Trial Outcomes & Findings for Study of the Gut Hormone Analogue Y14 in Adult Subjects (NCT NCT03673111)

Last Updated: 2025-03-18

Results Overview

As assessed by reporting of adverse events, vital signs, physical examination, clinical laboratory safety assessments, and ECG parameters. Possibly or definitely related to study drug

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

77 participants

Primary outcome timeframe

Up to 73 days after dosing

Results posted on

2025-03-18

Participant Flow

Single ascending dose - Part A: Cohort A1 comprised 4 subjects (3 active and 1 placebo): each volunteer was dosed in three treatment periods (TP) with three ascending dose levels (doses 1 mg, 2 mg, 6 mg Y14), with minimum washouts of 1 week between Day 1 of each TP. Within each TP three subjects were given the study drug and one placebo (sterile 0.9% \[w/v\] saline. Each volunteer in Cohort A2 onwards was dosed only once. Multiple ascending dose - Part B: Each participant received up to 5 doses

Participant milestones

Participant milestones
Measure	Y14 Single Ascending Dose (A1: TP1, TP2 & TP3) Sequential cross-over group received either Saline or 1 mg dose Y14 (A1) single dose, subcutaneous injection in the first treatment period; Saline or 2 mg dose Y14 single dose, subcutaneous injection in the second period, Saline or 6 mg dose Y14 single dose, subcutaneous injection in the third treatment period. Treatment periods were 12-15 days apart.	9.0 mg (A2) Y14 single dose, subcutaneous Y14: Gut hormone analogue	9 mg (A3) Y14 single dose, subcutaneous Y14: Gut hormone analogue	9 mg (A4) Y14 single dose, subcutaneous Y14: Gut hormone analogue	18.0 mg (A5) Y14 single dose, subcutaneous Y14: Gut hormone analogue	36.0 mg (A6) Y14 single dose, subcutaneous Y14: Gut hormone analogue	18 mg (A7) Y14 single dose, subcutaneous Y14: Gut hormone analogue	36 mg (A8) Y14 single dose, subcutaneous Y14: Gut hormone analogue	36 mg (A9) Y14 single dose, subcutaneous Y14: Gut hormone analogue	Placebo SAD (A2-A9) 0.9% saline Placebo: 0.9% saline	Placebo (Part B) 0.9% saline multiple subcutaneous injection: 5 injections over a 4 week treatment period	9-26.0 mg (B1) Y14 multiple dose, subcutaneous 5 doses over a 4 week treatment period: escalating doses up to maximum 26 mg Y14: Gut hormone analogue	9-36 mg (B2) Y14 multiple dose, subcutaneous 4 doses over a 4 week treatment period: escalating doses up to maximum 36 mg Y14: Gut hormone analogue	12-36 mg (B3) Y14 multiple dose, subcutaneous 4 doses over a 4 week treatment period: escalating doses up to a maximum of 36 mg Y14: Gut hormone analogue
Overall Study STARTED	5	5	5	5	5	5	5	5	5	8	6	6	6	6
Overall Study COMPLETED	4	5	5	5	5	5	5	5	5	8	5	6	6	6
Overall Study NOT COMPLETED	1	0	0	0	0	0	0	0	0	0	1	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Y14 Single Ascending Dose (A1: TP1, TP2 & TP3) Sequential cross-over group received either Saline or 1 mg dose Y14 (A1) single dose, subcutaneous injection in the first treatment period; Saline or 2 mg dose Y14 single dose, subcutaneous injection in the second period, Saline or 6 mg dose Y14 single dose, subcutaneous injection in the third treatment period. Treatment periods were 12-15 days apart.	9.0 mg (A2) Y14 single dose, subcutaneous Y14: Gut hormone analogue	9 mg (A3) Y14 single dose, subcutaneous Y14: Gut hormone analogue	9 mg (A4) Y14 single dose, subcutaneous Y14: Gut hormone analogue	18.0 mg (A5) Y14 single dose, subcutaneous Y14: Gut hormone analogue	36.0 mg (A6) Y14 single dose, subcutaneous Y14: Gut hormone analogue	18 mg (A7) Y14 single dose, subcutaneous Y14: Gut hormone analogue	36 mg (A8) Y14 single dose, subcutaneous Y14: Gut hormone analogue	36 mg (A9) Y14 single dose, subcutaneous Y14: Gut hormone analogue	Placebo SAD (A2-A9) 0.9% saline Placebo: 0.9% saline	Placebo (Part B) 0.9% saline multiple subcutaneous injection: 5 injections over a 4 week treatment period	9-26.0 mg (B1) Y14 multiple dose, subcutaneous 5 doses over a 4 week treatment period: escalating doses up to maximum 26 mg Y14: Gut hormone analogue	9-36 mg (B2) Y14 multiple dose, subcutaneous 4 doses over a 4 week treatment period: escalating doses up to maximum 36 mg Y14: Gut hormone analogue	12-36 mg (B3) Y14 multiple dose, subcutaneous 4 doses over a 4 week treatment period: escalating doses up to a maximum of 36 mg Y14: Gut hormone analogue
Overall Study Protocol Violation	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Overall Study Adverse Event	1	0	0	0	0	0	0	0	0	0	0	0	0	0

Baseline Characteristics

Study of the Gut Hormone Analogue Y14 in Adult Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SAD A1 n=5 Participants Sequential cross-over group received either Saline or 1 mg dose Y14 (A1) single dose, subcutaneous injection in the first treatment period; Saline or 2 mg dose Y14 single dose, subcutaneous injection in the second period, Saline or 6 mg dose Y14 single dose, subcutaneous injection in the third treatment period. Treatment periods were 12-15 days apart.	9.0 mg (A2) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	9 mg (A3) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	9 mg (A4) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	18.0 mg (A5) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	36.0 mg (A6) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	18 mg (A7) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	36 mg (A8) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	36 mg (A9) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	Placebo SAD A2-A9 n=8 Participants 0.9% saline Placebo: 0.9% saline	Placebo (Part B) n=6 Participants 0.9% saline multiple subcutaneous injection: 5 injections over a 4 week treatment period	9-26.0 mg (B1) n=6 Participants Y14 multiple dose, subcutaneous 5 doses over a 4 week treatment period: escalating dose up to 26 mg Y14: Gut hormone analogue	9-36 mg (B2) n=6 Participants Y14 multiple dose, subcutaneous 5 doses over a 4 week treatment period: escalating dose up to 36 mg Y14: Gut hormone analogue	12-36 mg (B3) n=6 Participants Y14 multiple dose, subcutaneous 5 doses over a 4 week treatment period: escalating dose up to 36 mg. Y14: Gut hormone analogue	Total n=77 Participants Total of all reporting groups
Age, Continuous	49.2 years STANDARD_DEVIATION 13.44 • n=5 Participants	28.2 years STANDARD_DEVIATION 5.02 • n=7 Participants	47.8 years STANDARD_DEVIATION 10.8 • n=5 Participants	41.2 years STANDARD_DEVIATION 13.3 • n=4 Participants	45.6 years STANDARD_DEVIATION 14.9 • n=21 Participants	47.8 years STANDARD_DEVIATION 1.5 • n=8 Participants	40.4 years STANDARD_DEVIATION 13.3 • n=8 Participants	44.2 years STANDARD_DEVIATION 12.5 • n=24 Participants	37.0 years STANDARD_DEVIATION 12.2 • n=42 Participants	44.8 years STANDARD_DEVIATION 11.5 • n=42 Participants	49.5 years STANDARD_DEVIATION 11.9 • n=42 Participants	36.7 years STANDARD_DEVIATION 10.0 • n=42 Participants	42.3 years STANDARD_DEVIATION 9.6 • n=36 Participants	40.8 years STANDARD_DEVIATION 9.7 • n=36 Participants	42.6 years STANDARD_DEVIATION 11.6 • n=24 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=8 Participants	5 Participants n=8 Participants	5 Participants n=24 Participants	5 Participants n=42 Participants	8 Participants n=42 Participants	6 Participants n=42 Participants	6 Participants n=42 Participants	6 Participants n=36 Participants	6 Participants n=36 Participants	77 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	2 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=36 Participants	0 Participants n=36 Participants	8 Participants n=24 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=8 Participants	4 Participants n=8 Participants	4 Participants n=24 Participants	5 Participants n=42 Participants	5 Participants n=42 Participants	5 Participants n=42 Participants	5 Participants n=42 Participants	5 Participants n=36 Participants	6 Participants n=36 Participants	66 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants
Region of Enrollment United Kingdom	5 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants	5 participants n=4 Participants	5 participants n=21 Participants	5 participants n=8 Participants	5 participants n=8 Participants	5 participants n=24 Participants	5 participants n=42 Participants	8 participants n=42 Participants	6 participants n=42 Participants	6 participants n=42 Participants	6 participants n=36 Participants	6 participants n=36 Participants	77 participants n=24 Participants
Body Weight (kg)	89.0 kg STANDARD_DEVIATION 12.41 • n=5 Participants	101.6 kg STANDARD_DEVIATION 12.7 • n=7 Participants	100.4 kg STANDARD_DEVIATION 11.3 • n=5 Participants	86.2 kg STANDARD_DEVIATION 11.78 • n=4 Participants	101.6 kg STANDARD_DEVIATION 9.6 • n=21 Participants	93.3 kg STANDARD_DEVIATION 5.60 • n=8 Participants	87.4 kg STANDARD_DEVIATION 13.3 • n=8 Participants	92.4 kg STANDARD_DEVIATION 16.47 • n=24 Participants	88.6 kg STANDARD_DEVIATION 7.4 • n=42 Participants	97.5 kg STANDARD_DEVIATION 14.9 • n=42 Participants	93.2 kg STANDARD_DEVIATION 14.8 • n=42 Participants	97.5 kg STANDARD_DEVIATION 14.0 • n=42 Participants	95.2 kg STANDARD_DEVIATION 9.8 • n=36 Participants	92.0 kg STANDARD_DEVIATION 8.1 • n=36 Participants	92.0 kg STANDARD_DEVIATION 12.09 • n=24 Participants
BMI (kg/m^2)	29.2 kg/m^2 STANDARD_DEVIATION 2.05 • n=5 Participants	30.0 kg/m^2 STANDARD_DEVIATION 2.70 • n=7 Participants	30.8 kg/m^2 STANDARD_DEVIATION 1.9 • n=5 Participants	27.6 kg/m^2 STANDARD_DEVIATION 2.4 • n=4 Participants	30.6 kg/m^2 STANDARD_DEVIATION 1.8 • n=21 Participants	28.8 kg/m^2 STANDARD_DEVIATION 1.87 • n=8 Participants	27.0 kg/m^2 STANDARD_DEVIATION 2.9 • n=8 Participants	30.6 kg/m^2 STANDARD_DEVIATION 4.2 • n=24 Participants	26.6 kg/m^2 STANDARD_DEVIATION 0.9 • n=42 Participants	30.1 kg/m^2 STANDARD_DEVIATION 2.9 • n=42 Participants	29.7 kg/m^2 STANDARD_DEVIATION 3.1 • n=42 Participants	30.2 kg/m^2 STANDARD_DEVIATION 3.9 • n=42 Participants	30.2 kg/m^2 STANDARD_DEVIATION 2.9 • n=36 Participants	29.5 kg/m^2 STANDARD_DEVIATION 2.1 • n=36 Participants	29.3 kg/m^2 STANDARD_DEVIATION 2.7 • n=24 Participants

PRIMARY outcome

Timeframe: Up to 73 days after dosing

As assessed by reporting of adverse events, vital signs, physical examination, clinical laboratory safety assessments, and ECG parameters. Possibly or definitely related to study drug

Outcome measures

Outcome measures
Measure	6.0 mg (A1) TP3 n=3 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	9.0 mg (A2) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	9 mg (A3) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	9 mg (A4) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	18.0 mg (A5) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	36.0 mg (A6) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	18 mg (A7) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	36 mg (A8) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	36 mg (A9) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	Placebo SAD A2-A9 n=8 Participants 0.9% saline Placebo: 0.9% saline	Placebo (Part B) n=6 Participants 0.9% saline multiple subcutaneous injection: 5 injections over a 4 week treatment period	9 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	12 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	16 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	20 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	26 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	9 mg Y14 (B2) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	24 mg Y14 (B2) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	36 mg Y14 (B2) 1st Dose n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	36mg Y14 (B2) 2nd Dose n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	12 mg Y14 (B3) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	24 mg Y14 (B3) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	36 mg Y14 (B3) 1st Dose Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	36 mg Y14 (B3) 2nd Dose Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	Placebo (A1) n=3 Participants 0.9% saline single subcutaneous injection	1.0 mg (A1) TP1 n=3 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	2.0 mg (A1) TP2 n=3 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (Safety and Tolerability)	3 Participants	5 Participants	4 Participants	1 Participants	5 Participants	5 Participants	4 Participants	5 Participants	5 Participants	3 Participants	3 Participants	5 Participants	4 Participants	6 Participants	5 Participants	6 Participants	6 Participants	6 Participants	5 Participants	6 Participants	5 Participants	6 Participants	—	—	2 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: For Part A, Cohorts A3 to A9 - up to 840 hour post dose. For Part B - up to day 70 post 1st dose

Population: PK Parameters: N/A= For the doses given to cohorts A1, A2 and A3, Y14 was below the LLOQ(\<0.2 ng/mL) in most samples (BLQ=below the limit of quantification), so the data for cohort A4 onwards are presented. Only subjects receiving Y14 were analysed

The maximum observed concentration

Outcome measures

Outcome measures
Measure	6.0 mg (A1) TP3 n=3 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	9.0 mg (A2) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	9 mg (A3) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	9 mg (A4) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	18.0 mg (A5) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	36.0 mg (A6) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	18 mg (A7) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	36 mg (A8) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	36 mg (A9) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	Placebo SAD A2-A9 n=8 Participants 0.9% saline Placebo: 0.9% saline	Placebo (Part B) n=6 Participants 0.9% saline multiple subcutaneous injection: 5 injections over a 4 week treatment period	9 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	12 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	16 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	20 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	26 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	9 mg Y14 (B2) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	24 mg Y14 (B2) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	36 mg Y14 (B2) 1st Dose n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	36mg Y14 (B2) 2nd Dose n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	12 mg Y14 (B3) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	24 mg Y14 (B3) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	36 mg Y14 (B3) 1st Dose n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	36 mg Y14 (B3) 2nd Dose n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	Placebo (A1) n=3 Participants 0.9% saline single subcutaneous injection	1.0 mg (A1) TP1 n=3 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	2.0 mg (A1) TP2 n=3 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue
Cmax	NA ng/mL Geometric Coefficient of Variation NA BLQ	NA ng/mL Geometric Coefficient of Variation NA BLQ	NA ng/mL Geometric Coefficient of Variation NA BLQ	0.459 ng/mL Geometric Coefficient of Variation 44	0.383 ng/mL Geometric Coefficient of Variation 46	0.607 ng/mL Geometric Coefficient of Variation 111	0.677 ng/mL Geometric Coefficient of Variation 66	0.908 ng/mL Geometric Coefficient of Variation 81	0.704 ng/mL Geometric Coefficient of Variation 59	NA ng/mL Geometric Coefficient of Variation NA BLQ	NA ng/mL Geometric Coefficient of Variation NA BLQ	0.640 ng/mL Geometric Coefficient of Variation 39	0.870 ng/mL Geometric Coefficient of Variation 26	1.32 ng/mL Geometric Coefficient of Variation 35	1.64 ng/mL Geometric Coefficient of Variation 19	1.48 ng/mL Geometric Coefficient of Variation 49	0.389 ng/mL Geometric Coefficient of Variation 41	0.702 ng/mL Geometric Coefficient of Variation 52	1.4 ng/mL Geometric Coefficient of Variation 21	1.1 ng/mL Geometric Coefficient of Variation 66	0.355 ng/mL Geometric Coefficient of Variation 37	0.787 ng/mL Geometric Coefficient of Variation 35	1.35 ng/mL Geometric Coefficient of Variation 20	1.54 ng/mL Geometric Coefficient of Variation 41	NA ng/mL Geometric Coefficient of Variation NA BLQ	NA ng/mL Geometric Coefficient of Variation NA BLQ	NA ng/mL Geometric Coefficient of Variation NA BLQ

SECONDARY outcome

Timeframe: Up to 72hr after dosing

Population: PK Parameters: N/A = For the doses given to cohorts A1, A2, A3 and A5, Y14 was below the LLOQ(\<0.2 ng/mL) in most samples (BLQ=below the limit of quantification), so the data for cohort A4 and cohort A6 onwards are presented. Only subjects receiving Y14 were analysed

The area under the concentration versus time curve from time zero to 72 h postdose, calculated by the mixed linear/log trapezoidal rule

Outcome measures

Outcome measures
Measure	6.0 mg (A1) TP3 n=3 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	9.0 mg (A2) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	9 mg (A3) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	9 mg (A4) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	18.0 mg (A5) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	36.0 mg (A6) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	18 mg (A7) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	36 mg (A8) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	36 mg (A9) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	Placebo SAD A2-A9 n=8 Participants 0.9% saline Placebo: 0.9% saline	Placebo (Part B) n=6 Participants 0.9% saline multiple subcutaneous injection: 5 injections over a 4 week treatment period	9 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	12 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	16 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	20 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	26 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	9 mg Y14 (B2) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	24 mg Y14 (B2) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	36 mg Y14 (B2) 1st Dose n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	36mg Y14 (B2) 2nd Dose n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	12 mg Y14 (B3) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	24 mg Y14 (B3) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	36 mg Y14 (B3) 1st Dose n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	36 mg Y14 (B3) 2nd Dose n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	Placebo (A1) n=3 Participants 0.9% saline single subcutaneous injection	1.0 mg (A1) TP1 n=3 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	2.0 mg (A1) TP2 n=3 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue
AUC 0-72h	NA ng.h/mL Geometric Coefficient of Variation NA BLQ	NA ng.h/mL Geometric Coefficient of Variation NA BLQ	NA ng.h/mL Geometric Coefficient of Variation NA BLQ	16.4 ng.h/mL Geometric Coefficient of Variation 83	NA ng.h/mL Geometric Coefficient of Variation NA BLQ	24.4 ng.h/mL Geometric Coefficient of Variation 21	26.3 ng.h/mL Geometric Coefficient of Variation 105	34.0 ng.h/mL Geometric Coefficient of Variation 50	33.4 ng.h/mL Geometric Coefficient of Variation 51	NA ng.h/mL Geometric Coefficient of Variation NA BLQ	NA ng.h/mL Geometric Coefficient of Variation NA BLQ	19.7 ng.h/mL Geometric Coefficient of Variation 89.7	53.2 ng.h/mL Geometric Coefficient of Variation 21	76.7 ng.h/mL Geometric Coefficient of Variation 26	89.6 ng.h/mL Geometric Coefficient of Variation 17	81.2 ng.h/mL Geometric Coefficient of Variation 45	10.1 ng.h/mL Geometric Coefficient of Variation 303	38.1 ng.h/mL Geometric Coefficient of Variation 34	82.1 ng.h/mL Geometric Coefficient of Variation 21	63.6 ng.h/mL Geometric Coefficient of Variation 76	9.67 ng.h/mL Geometric Coefficient of Variation 165	40.4 ng.h/mL Geometric Coefficient of Variation 36	86.6 ng.h/mL Geometric Coefficient of Variation 22	87.2 ng.h/mL Geometric Coefficient of Variation 34	NA ng.h/mL Geometric Coefficient of Variation NA BLQ	NA ng.h/mL Geometric Coefficient of Variation NA BLQ	NA ng.h/mL Geometric Coefficient of Variation NA BLQ

SECONDARY outcome

Timeframe: Up to 168h after dosing

Population: PK Parameters: N/A = For the doses given to cohorts A1, A2, A3 and A4, Y14 was below the LLOQ(\<0.2 ng/mL) in most samples (BLQ=below the limit of quantification), so the data for cohort A5 onwards are presented. Only subjects receiving Y14 were analysed

The area under the concentration versus time curve within a (168 h) dosing interval, calculated by the mixed linear/log trapezoidal rule (equivalent to AUC0-168h, which was calculated as the area under the concentration versus time curve from time zero to 168 h post-dose after a single dose, calculated by the mixed linear/log trapezoidal rule).

Outcome measures

Outcome measures
Measure	6.0 mg (A1) TP3 n=3 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	9.0 mg (A2) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	9 mg (A3) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	9 mg (A4) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	18.0 mg (A5) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	36.0 mg (A6) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	18 mg (A7) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	36 mg (A8) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	36 mg (A9) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	Placebo SAD A2-A9 n=8 Participants 0.9% saline Placebo: 0.9% saline	Placebo (Part B) n=6 Participants 0.9% saline multiple subcutaneous injection: 5 injections over a 4 week treatment period	9 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	12 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	16 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	20 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	26 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	9 mg Y14 (B2) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	24 mg Y14 (B2) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	36 mg Y14 (B2) 1st Dose n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	36mg Y14 (B2) 2nd Dose n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	12 mg Y14 (B3) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	24 mg Y14 (B3) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	36 mg Y14 (B3) 1st Dose n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	36 mg Y14 (B3) 2nd Dose n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	Placebo (A1) n=3 Participants 0.9% saline single subcutaneous injection	1.0 mg (A1) TP1 n=3 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	2.0 mg (A1) TP2 n=3 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue
AUC 0-τ	NA ng.h/mL Geometric Coefficient of Variation NA BLQ	NA ng.h/mL Geometric Coefficient of Variation NA BLQ	NA ng.h/mL Geometric Coefficient of Variation NA BLQ	NA ng.h/mL Geometric Coefficient of Variation NA BLQ	64.0 ng.h/mL Geometric Coefficient of Variation 105	164 ng.h/mL Geometric Coefficient of Variation 199	65.2 ng.h/mL Geometric Coefficient of Variation 126	78.2 ng.h/mL Geometric Coefficient of Variation 47	59.2 ng.h/mL Geometric Coefficient of Variation 84.6	NA ng.h/mL Geometric Coefficient of Variation NA BLQ	NA ng.h/mL Geometric Coefficient of Variation NA BLQ	24.8 ng.h/mL Geometric Coefficient of Variation 127	108 ng.h/mL Geometric Coefficient of Variation 18.7	139 ng.h/mL Geometric Coefficient of Variation 17	153 ng.h/mL Geometric Coefficient of Variation 16	144 ng.h/mL Geometric Coefficient of Variation 53	15.6 ng.h/mL Geometric Coefficient of Variation 598	107 ng.h/mL Geometric Coefficient of Variation 31	159 ng.h/mL Geometric Coefficient of Variation 25	154 ng.h/mL Geometric Coefficient of Variation 76	17.0 ng.h/mL Geometric Coefficient of Variation 298	106 ng.h/mL Geometric Coefficient of Variation 28	193 ng.h/mL Geometric Coefficient of Variation 19	225 ng.h/mL Geometric Coefficient of Variation 48	NA ng.h/mL Geometric Coefficient of Variation NA BLQ	NA ng.h/mL Geometric Coefficient of Variation NA BLQ	NA ng.h/mL Geometric Coefficient of Variation NA BLQ

SECONDARY outcome

Timeframe: For Part A, Cohorts A3 to A9 - up to 840 hour post dose. For Part B - up to day 70 post 1st dose

Population: PK Parameters: NA= Values below the limit of quantification (BLQ) For the doses given to cohorts in Part A, Y14 was below the lower limit of quantification (\<0.2 ng/mL) in most samples and it was not possible to estimate an unambiguous Tmax or T1/2 due to the extended PK profile of Y14. Therefore the data for Part B only are presented. Participants who received placebo were not assessed for this measure, therefore only subjects receiving Y14 were analysed

Drug Half-life (t1/2) is defined as the amount of time (hours) required for the drug concentration to be reduced to exactly half its initial concentration or amount in blood. The apparent terminal half-life, calculated from Loge 2 / λz: For Part A cohorts, it was not possible to estimate an unambiguous Tmax or T1/2 due to the extended PK profile of Y14. For Part B cohorts, no individual administered dose half-life data were collected for this outcome, but one half-life value was measured after all doses had been administered and these values were analysed only for the treated-arms that is B1, B2 and B3.

Outcome measures

Outcome measures
Measure	6.0 mg (A1) TP3 n=3 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	9.0 mg (A2) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	9 mg (A3) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	9 mg (A4) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	18.0 mg (A5) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	36.0 mg (A6) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	18 mg (A7) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	36 mg (A8) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	36 mg (A9) n=5 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	Placebo SAD A2-A9 0.9% saline Placebo: 0.9% saline	Placebo (Part B) 0.9% saline multiple subcutaneous injection: 5 injections over a 4 week treatment period	9 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	12 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	16 mg Y14 (B1) n=6 Participants Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	20 mg Y14 (B1) Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	26 mg Y14 (B1) Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	9 mg Y14 (B2) Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	24 mg Y14 (B2) Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	36 mg Y14 (B2) 1st Dose Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	36mg Y14 (B2) 2nd Dose Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	12 mg Y14 (B3) Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	24 mg Y14 (B3) Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	36 mg Y14 (B3) 1st Dose Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	36 mg Y14 (B3) 2nd Dose Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	Placebo (A1) 0.9% saline single subcutaneous injection	1.0 mg (A1) TP1 n=3 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue	2.0 mg (A1) TP2 n=3 Participants Y14 single dose, subcutaneous Y14: Gut hormone analogue
T 1/2	NA hours Geometric Coefficient of Variation NA Not available (BLQ)	NA hours Geometric Coefficient of Variation NA Not available (BLQ)	NA hours Geometric Coefficient of Variation NA Not available (BLQ)	NA hours Geometric Coefficient of Variation NA Not available (BLQ)	NA hours Geometric Coefficient of Variation NA Not available (BLQ)	NA hours Geometric Coefficient of Variation NA Not available (BLQ)	NA hours Geometric Coefficient of Variation NA Not available (BLQ)	NA hours Geometric Coefficient of Variation NA Not available (BLQ)	NA hours Geometric Coefficient of Variation NA Not available (BLQ)	—	—	277 hours Geometric Coefficient of Variation 106	294 hours Geometric Coefficient of Variation 46	190 hours Geometric Coefficient of Variation 28	—	—	—	—	—	—	—	—	—	—	—	NA hours Geometric Coefficient of Variation NA Not available: Below the limit of quantification (BLQ)	NA hours Geometric Coefficient of Variation NA Not available (BLQ)

Deaths: 0 deaths

36 mg Y14 (B3)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo (A1) n=3 participants at risk 0.9% saline single subcutaneous injection	1.0 mg (A1) TP1 n=3 participants at risk Y14 single dose, subcutaneous Y14: Gut hormone analogue	2.0 mg (A1) TP2 n=3 participants at risk Y14 single dose, subcutaneous Y14: Gut hormone analogue	6.0 mg (A1) TP3 n=3 participants at risk Y14 single dose, subcutaneous Y14: Gut hormone analogue	Placebo SAD (A2-A9) n=8 participants at risk 0.9% saline Placebo: 0.9% saline	9 mg (A4) n=5 participants at risk Y14 single dose, subcutaneous Y14: Gut hormone analogue	9 mg (A3) n=5 participants at risk Y14 single dose, subcutaneous Y14: Gut hormone analogue	9.0 mg (A2) n=5 participants at risk Y14 single dose, subcutaneous Y14: Gut hormone analogue	18 mg (A7) n=5 participants at risk Y14 single dose, subcutaneous Y14: Gut hormone analogue	18.0 mg (A5) n=5 participants at risk Y14 single dose, subcutaneous Y14: Gut hormone analogue	36 mg (A8) n=5 participants at risk Y14 single dose, subcutaneous Y14: Gut hormone analogue	36.0 mg (A6) n=5 participants at risk Y14 single dose, subcutaneous Y14: Gut hormone analogue	36 mg (A9) n=5 participants at risk Y14 single dose, subcutaneous Y14: Gut hormone analogue	Placebo (Part B) n=6 participants at risk 0.9% saline multiple subcutaneous injection: 5 injections over a 4 week treatment period	9 mg Y14 (B1) n=6 participants at risk Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	9 mg Y14 (B2) n=6 participants at risk Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	12 mg Y14 (B1) n=6 participants at risk Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	12 mg Y14 (B3) n=6 participants at risk Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	16 mg Y14 (B1) n=6 participants at risk Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	20 mg Y14 (B1) n=6 participants at risk Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	24 mg Y14 (B2) n=6 participants at risk Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	24 mg Y14 (B3) n=6 participants at risk Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	26 mg Y14 (B1) n=6 participants at risk Y14 multiple dose, subcutaneous injection: 1 of 5 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	36 mg Y14 (B2) n=6 participants at risk Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue	36 mg Y14 (B3) n=6 participants at risk Y14 multiple dose, subcutaneous injection: 1 of 4 doses over a 4 week treatment period at escalating doses. Y14: Gut hormone analogue
General disorders Feeling hot	33.3% 1/3 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
General disorders Early Satiety	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	12.5% 1/8 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
General disorders Fatigue	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	12.5% 1/8 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	60.0% 3/5 • Number of events 3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
General disorders Feeling abnormal	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
General disorders Feeling cold	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Ear and labyrinth disorders Ear discomfort	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 1/3 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	12.5% 1/8 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	40.0% 2/5 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Gastrointestinal disorders Abdominal tenderness	33.3% 1/3 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 1/3 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Gastrointestinal disorders Constipation	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	40.0% 2/5 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	50.0% 3/6 • Number of events 3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	50.0% 3/6 • Number of events 4 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Gastrointestinal disorders Dry Mouth	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	12.5% 1/8 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Gastrointestinal disorders Gastrointestinal sounds abnormal	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 1/3 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	25.0% 2/8 • Number of events 3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	60.0% 3/5 • Number of events 3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	80.0% 4/5 • Number of events 4 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	80.0% 4/5 • Number of events 5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	80.0% 4/5 • Number of events 4 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	100.0% 5/5 • Number of events 13 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	60.0% 3/5 • Number of events 3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	66.7% 4/6 • Number of events 7 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	66.7% 4/6 • Number of events 5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	50.0% 3/6 • Number of events 3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	50.0% 3/6 • Number of events 5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	50.0% 3/6 • Number of events 4 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Gastrointestinal disorders Retching	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Gastrointestinal disorders Vomiting	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	40.0% 2/5 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	60.0% 3/5 • Number of events 3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	60.0% 3/5 • Number of events 4 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	40.0% 2/5 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
General disorders Asthenia	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
General disorders Chest Pain	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
General disorders Injection site erythema	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 1/3 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	40.0% 2/5 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	66.7% 4/6 • Number of events 4 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	50.0% 3/6 • Number of events 3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	50.0% 3/6 • Number of events 4 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	100.0% 6/6 • Number of events 12 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
General disorders Injection site injuration	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 1/3 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
General disorders Injection site mass	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 1/3 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 1/3 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	12.5% 1/8 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	80.0% 4/5 • Number of events 4 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	100.0% 5/5 • Number of events 5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	100.0% 5/5 • Number of events 5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	80.0% 4/5 • Number of events 4 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	100.0% 5/5 • Number of events 5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	80.0% 4/5 • Number of events 5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	50.0% 3/6 • Number of events 3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	83.3% 5/6 • Number of events 5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	66.7% 4/6 • Number of events 4 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	50.0% 3/6 • Number of events 3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	66.7% 4/6 • Number of events 4 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	83.3% 5/6 • Number of events 5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	83.3% 5/6 • Number of events 5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	66.7% 4/6 • Number of events 7 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	100.0% 6/6 • Number of events 11 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
General disorders Injection site pain	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 1/3 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	60.0% 3/5 • Number of events 7 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	50.0% 3/6 • Number of events 3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	66.7% 4/6 • Number of events 6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
General disorders Injection site pruritus	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	40.0% 2/5 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
General disorders Injection site reaction	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	40.0% 2/5 • Number of events 3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
General disorders Pain	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
General disorders Pyrexia	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
General disorders Sensation of foreign body	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 1/3 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Immune system disorders Seasonal allergy	33.3% 1/3 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Infections and infestations Oral Herpes	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Infections and infestations Viral upper respiratory tract infection	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	80.0% 4/5 • Number of events 4 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	40.0% 2/5 • Number of events 3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	12.5% 1/8 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 1/3 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 1/3 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	80.0% 4/5 • Number of events 4 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	100.0% 5/5 • Number of events 5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	50.0% 3/6 • Number of events 4 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	12.5% 1/8 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Nervous system disorders Dizziness	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	40.0% 2/5 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	50.0% 3/6 • Number of events 3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Nervous system disorders Dysgeusia	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Nervous system disorders Headache	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 1/3 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	40.0% 2/5 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	40.0% 2/5 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	40.0% 2/5 • Number of events 5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	40.0% 2/5 • Number of events 5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	50.0% 3/6 • Number of events 8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 4 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	50.0% 3/6 • Number of events 4 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 4 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	50.0% 3/6 • Number of events 4 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	50.0% 3/6 • Number of events 4 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 4 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 1/3 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	20.0% 1/5 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 1/3 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	12.5% 1/8 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Gastrointestinal disorders Abdominal discomfort	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Gastrointestinal disorders Anal pruritus	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Gastrointestinal disorders Change of bowel habit	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Gastrointestinal disorders Faeces hard	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Gastrointestinal disorders Haematochezia	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Gastrointestinal disorders Mouth ulceration	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Gastrointestinal disorders Paraesthesia oral	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
General disorders Feeling of body temperature change	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
General disorders Injection site oedema	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
General disorders Injection site swelling	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
General disorders Mass	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
General disorders Thirst	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Infections and infestations Epididymitis	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Infections and infestations Urinary tract infection	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Injury, poisoning and procedural complications Limb injury	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Investigations Blood glucose decreased	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Metabolism and nutrition disorders Appetite disorder	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Metabolism and nutrition disorders Food craving	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Nervous system disorders Lethargy	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Nervous system disorders Somnolence	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	33.3% 2/6 • Number of events 2 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
Surgical and medical procedures Tooth extraction	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/3 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/8 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/5 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	16.7% 1/6 • Number of events 1 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).	0.00% 0/6 • Up to 21 weeks from participant start date The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).

Additional Information

Professor Tricia Tan

Imperial College London

Phone: 020 8383 8038

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place