Trial Outcomes & Findings for A Study of Tirzepatide (LY3298176) in Healthy Participants and Participants With Type 2 Diabetes (T2DM) (NCT NCT02759107)

Last Updated: 2024-01-16

Results Overview

Number of participants with one or more SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

142 participants

Primary outcome timeframe

Baseline through Day 43 (Part A) and Day 57 (Part B and C)

Results posted on

2024-01-16

Participant Flow

Participant milestones

Participant milestones
Measure	Part A Placebo Participants received placebo by subcutaneous (SC) injection.	Part A 0.25 mg Tirzepatide Participants received single dose of 0.25 milligram (mg) Tirzepatide by subcutaneous injection.	Part A 0.5mg Tirzepatide Participants received single dose of 0.5mg Tirzepatide by subcutaneous injection.	Part A 1mg Tirzepatide Participants received single dose of 1mg Tirzepatide by subcutaneous injection.	Part A 2.5mg Tirzepatide Participants received single dose of 2.5mg Tirzepatide by subcutaneous injection.	Part A 5mg Tirzepatide Participants received single dose of 5mg Tirzepatide by subcutaneous injection.	Part A 8mg Tirzepatide Participants received single dose of 8mg Tirzepatide by subcutaneous injection.	Part B Placebo Participants received placebo by subcutaneous injection.	Part B 1.5mg Dulaglutide Participants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection.	Part B 0.5mg Tirzepatide Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part B 1.5mg Tirzepatide Participants received 1.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part B 4.5mg Tirzepatide Participants received 4.5mg Tirzepatide once weekly for four weeks by subcutaneous injections.	Part B 5, 5, 8,10mg Tirzepatide Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 8mg QW followed by 10mg QW.	Part C Placebo Participants received placebo by subcutaneous injection.	Part C 0.5mg Tirzepatide Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part C 5mg Tirzepatide Participants received 5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part C 5, 5, 10,10mg Tirzepatide Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 10mg QW.	Part C 5, 5, 10,15mg Tirzepatide Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 15mg QW.
Overall Study STARTED	14	6	12	5	6	6	7	4	4	6	6	6	7	11	9	9	12	12
Overall Study Received at Least One Dose of Study Drug	14	6	12	5	6	6	7	4	4	6	6	6	7	11	9	9	12	12
Overall Study COMPLETED	14	6	12	5	6	6	7	4	4	5	6	6	5	11	9	8	12	10
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	1	0	0	2	0	0	1	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A Placebo Participants received placebo by subcutaneous (SC) injection.	Part A 0.25 mg Tirzepatide Participants received single dose of 0.25 milligram (mg) Tirzepatide by subcutaneous injection.	Part A 0.5mg Tirzepatide Participants received single dose of 0.5mg Tirzepatide by subcutaneous injection.	Part A 1mg Tirzepatide Participants received single dose of 1mg Tirzepatide by subcutaneous injection.	Part A 2.5mg Tirzepatide Participants received single dose of 2.5mg Tirzepatide by subcutaneous injection.	Part A 5mg Tirzepatide Participants received single dose of 5mg Tirzepatide by subcutaneous injection.	Part A 8mg Tirzepatide Participants received single dose of 8mg Tirzepatide by subcutaneous injection.	Part B Placebo Participants received placebo by subcutaneous injection.	Part B 1.5mg Dulaglutide Participants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection.	Part B 0.5mg Tirzepatide Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part B 1.5mg Tirzepatide Participants received 1.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part B 4.5mg Tirzepatide Participants received 4.5mg Tirzepatide once weekly for four weeks by subcutaneous injections.	Part B 5, 5, 8,10mg Tirzepatide Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 8mg QW followed by 10mg QW.	Part C Placebo Participants received placebo by subcutaneous injection.	Part C 0.5mg Tirzepatide Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part C 5mg Tirzepatide Participants received 5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part C 5, 5, 10,10mg Tirzepatide Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 10mg QW.	Part C 5, 5, 10,15mg Tirzepatide Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 15mg QW.
Overall Study Adverse Event	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	1	0	2
Overall Study Scheduling Conflict	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0

Baseline Characteristics

A Study of Tirzepatide (LY3298176) in Healthy Participants and Participants With Type 2 Diabetes (T2DM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A Placebo n=14 Participants Participants received placebo by subcutaneous (SC) injection.	Part A 0.25 mg Tirzepatide n=6 Participants Participants received single dose of 0.25mg Tirzepatide by subcutaneous injection.	Part A 0.5mg Tirzepatide n=12 Participants Participants received single dose of 0.5mg Tirzepatide by subcutaneous injection.	Part A 1mg Tirzepatide n=5 Participants Participants received single dose of 1mg Tirzepatide by subcutaneous injection.	Part A 2.5mg Tirzepatide n=6 Participants Participants received single dose of 2.5mg Tirzepatide by subcutaneous injection.	Part A 5mg Tirzepatide n=6 Participants Participants received single dose of 5mg Tirzepatide by subcutaneous injection.	Part A 8mg Tirzepatide n=7 Participants Participants received single dose of 8mg Tirzepatide by subcutaneous injection.	Part B Placebo n=4 Participants Participants received placebo by subcutaneous injection.	Part B 1.5mg Dulaglutide n=4 Participants Participants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection.	Part B 0.5mg Tirzepatide n=6 Participants Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part B 1.5mg Tirzepatide n=6 Participants Participants received 1.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part B 4.5mg Tirzepatide n=6 Participants Participants received 4.5mg Tirzepatide once weekly for four weeks by subcutaneous injections.	Part B 5, 5, 8,10mg Tirzepatide n=7 Participants Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 8mg QW followed by 10mg QW.	Part C Placebo n=11 Participants Participants received placebo by subcutaneous injection.	Part C 0.5mg Tirzepatide n=9 Participants Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part C 5mg Tirzepatide n=9 Participants Participants received 5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part C 5, 5, 10,10mg Tirzepatide n=12 Participants Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 10mg QW.	Part C 5, 5, 10,15mg Tirzepatide n=12 Participants Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 15mg QW.	Total n=142 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=2 Participants	0 Participants n=102 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=99 Participants	6 Participants n=107 Participants	12 Participants n=206 Participants	4 Participants n=7 Participants	6 Participants n=31 Participants	6 Participants n=30 Participants	7 Participants n=3 Participants	4 Participants n=6 Participants	4 Participants n=114 Participants	6 Participants	6 Participants n=19 Participants	6 Participants n=4 Participants	7 Participants n=7 Participants	7 Participants n=7 Participants	7 Participants n=3 Participants	8 Participants n=4 Participants	12 Participants n=2 Participants	11 Participants n=102 Participants	133 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants	4 Participants n=7 Participants	2 Participants n=3 Participants	1 Participants n=4 Participants	0 Participants n=2 Participants	1 Participants n=102 Participants	9 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	6 Participants n=4 Participants	0 Participants n=7 Participants	4 Participants n=7 Participants	6 Participants n=3 Participants	7 Participants n=4 Participants	2 Participants n=2 Participants	6 Participants n=102 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=99 Participants	5 Participants n=107 Participants	11 Participants n=206 Participants	4 Participants n=7 Participants	6 Participants n=31 Participants	6 Participants n=30 Participants	7 Participants n=3 Participants	4 Participants n=6 Participants	4 Participants n=114 Participants	6 Participants	6 Participants n=19 Participants	0 Participants n=4 Participants	7 Participants n=7 Participants	7 Participants n=7 Participants	3 Participants n=3 Participants	2 Participants n=4 Participants	10 Participants n=2 Participants	6 Participants n=102 Participants	108 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants	10 Participants n=7 Participants	9 Participants n=3 Participants	8 Participants n=4 Participants	7 Participants n=2 Participants	12 Participants n=102 Participants	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=99 Participants	6 Participants n=107 Participants	12 Participants n=206 Participants	5 Participants n=7 Participants	6 Participants n=31 Participants	6 Participants n=30 Participants	7 Participants n=3 Participants	4 Participants n=6 Participants	4 Participants n=114 Participants	6 Participants	6 Participants n=19 Participants	6 Participants n=4 Participants	7 Participants n=7 Participants	1 Participants n=7 Participants	0 Participants n=3 Participants	1 Participants n=4 Participants	5 Participants n=2 Participants	0 Participants n=102 Participants	96 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=2 Participants	0 Participants n=102 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants	1 Participants n=7 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=2 Participants	0 Participants n=102 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=99 Participants	6 Participants n=107 Participants	12 Participants n=206 Participants	5 Participants n=7 Participants	6 Participants n=31 Participants	6 Participants n=30 Participants	7 Participants n=3 Participants	4 Participants n=6 Participants	4 Participants n=114 Participants	6 Participants	6 Participants n=19 Participants	5 Participants n=4 Participants	7 Participants n=7 Participants	1 Participants n=7 Participants	0 Participants n=3 Participants	1 Participants n=4 Participants	5 Participants n=2 Participants	0 Participants n=102 Participants	94 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	1 Participants n=4 Participants	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=2 Participants	0 Participants n=102 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants	2 Participants n=7 Participants	0 Participants n=3 Participants	1 Participants n=4 Participants	0 Participants n=2 Participants	1 Participants n=102 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants	7 Participants n=7 Participants	9 Participants n=3 Participants	7 Participants n=4 Participants	7 Participants n=2 Participants	11 Participants n=102 Participants	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=2 Participants	0 Participants n=102 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=2 Participants	0 Participants n=102 Participants	0 Participants n=5 Participants
Region of Enrollment Singapore	14 Participants n=99 Participants	6 Participants n=107 Participants	12 Participants n=206 Participants	5 Participants n=7 Participants	6 Participants n=31 Participants	6 Participants n=30 Participants	7 Participants n=3 Participants	4 Participants n=6 Participants	4 Participants n=114 Participants	6 Participants	6 Participants n=19 Participants	6 Participants n=4 Participants	7 Participants n=7 Participants	1 Participants n=7 Participants	0 Participants n=3 Participants	1 Participants n=4 Participants	5 Participants n=2 Participants	0 Participants n=102 Participants	96 Participants n=5 Participants
Region of Enrollment United States	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants	10 Participants n=7 Participants	9 Participants n=3 Participants	8 Participants n=4 Participants	7 Participants n=2 Participants	12 Participants n=102 Participants	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline through Day 43 (Part A) and Day 57 (Part B and C)

Population: All randomized participants who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Tirzepatide (Part A) n=42 Participants Participants received escalating doses of either 0.25mg or 0.5mg or 1mg, or 2.5mg or 5mg or 8mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Placebo (Part A) n=14 Participants Participants received placebo once weekly for four weeks by subcutaneous injection.	Tirzepatide (Part B) n=25 Participants Participants received escalating doses of either 0.5mg or 1.5mg or 4.5mg or titrated doses of 5mg, 5mg, 8mg and 10mg once weekly for four weeks by subcutaneous injection.	Placebo (Part B) n=4 Participants Participants received placebo once weekly for four weeks by subcutaneous injection.	Dulaglutide (Part B) n=4 Participants Participants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection.	Tirzepatide (Part C) n=42 Participants Participants received either 0.5mg or 5mg or titrated doses of 5mg,5mg,10mg,10mg or 5mg,5mg,10mg,15mg Tirzepatide once weekly for four weeks by subcutaneous injection	Placebo (Part C) n=11 Participants Participants received placebo once weekly for four weeks by subcutaneous injection.
Number of Participants With One or More Serious Adverse Event(s) (SAEs)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Predose, 8hours(h), 24h,48h,72h,96h,120h,168h,336h postdose, day 29, day 43

Population: All randomized participants in part A who received at least one dose of Tirzepatide and had evaluable PK data.

Area under the concentration versus time curve from zero to infinity (AUC \[0-∞\]) of Tirzepatide in Part A.

Outcome measures

Outcome measures
Measure	Tirzepatide (Part A) n=6 Participants Participants received escalating doses of either 0.25mg or 0.5mg or 1mg, or 2.5mg or 5mg or 8mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Placebo (Part A) n=12 Participants Participants received placebo once weekly for four weeks by subcutaneous injection.	Tirzepatide (Part B) n=5 Participants Participants received escalating doses of either 0.5mg or 1.5mg or 4.5mg or titrated doses of 5mg, 5mg, 8mg and 10mg once weekly for four weeks by subcutaneous injection.	Placebo (Part B) n=6 Participants Participants received placebo once weekly for four weeks by subcutaneous injection.	Dulaglutide (Part B) n=5 Participants Participants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection.	Tirzepatide (Part C) n=7 Participants Participants received either 0.5mg or 5mg or titrated doses of 5mg,5mg,10mg,10mg or 5mg,5mg,10mg,15mg Tirzepatide once weekly for four weeks by subcutaneous injection	Placebo (Part C) Participants received placebo once weekly for four weeks by subcutaneous injection.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part A.	5760 Hour * nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 22	12000 Hour * nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 24	22600 Hour * nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 14	53200 Hour * nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 36	90500 Hour * nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 15	169000 Hour * nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 8	—

SECONDARY outcome

Timeframe: Predose, 8hours(h), 24h,48h,72h,168h postdose

Population: All randomized participants in part B who received at least one dose of the Tirzepatide and had evaluable PK data.

Area under the concentration versus time curve during 1 dosing interval (AUC \[0-τ\]) of Tirzepatide in Part B. τ equals 168 hours.

Outcome measures

Outcome measures
Measure	Tirzepatide (Part A) n=6 Participants Participants received escalating doses of either 0.25mg or 0.5mg or 1mg, or 2.5mg or 5mg or 8mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Placebo (Part A) n=6 Participants Participants received placebo once weekly for four weeks by subcutaneous injection.	Tirzepatide (Part B) n=6 Participants Participants received escalating doses of either 0.5mg or 1.5mg or 4.5mg or titrated doses of 5mg, 5mg, 8mg and 10mg once weekly for four weeks by subcutaneous injection.	Placebo (Part B) n=7 Participants Participants received placebo once weekly for four weeks by subcutaneous injection.	Dulaglutide (Part B) Participants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection.	Tirzepatide (Part C) Participants received either 0.5mg or 5mg or titrated doses of 5mg,5mg,10mg,10mg or 5mg,5mg,10mg,15mg Tirzepatide once weekly for four weeks by subcutaneous injection	Placebo (Part C) Participants received placebo once weekly for four weeks by subcutaneous injection.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part B	6000 Hour * nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 23	16300 Hour * nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 13	53300 Hour * nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 19	56900 Hour * nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 10	—	—	—

SECONDARY outcome

Timeframe: Predose, 8hours(h), 24h,48h,72h,168h postdose

Population: All randomized participants in part C who received at least one dose of Tirzepatide and had evaluable PK data.

Area under the concentration versus time curve during 1 dosing interval (AUC \[0-τ\]) of Tirzepatide in Part C. τ equals 168 hours.

Outcome measures

Outcome measures
Measure	Tirzepatide (Part A) n=9 Participants Participants received escalating doses of either 0.25mg or 0.5mg or 1mg, or 2.5mg or 5mg or 8mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Placebo (Part A) n=8 Participants Participants received placebo once weekly for four weeks by subcutaneous injection.	Tirzepatide (Part B) n=12 Participants Participants received escalating doses of either 0.5mg or 1.5mg or 4.5mg or titrated doses of 5mg, 5mg, 8mg and 10mg once weekly for four weeks by subcutaneous injection.	Placebo (Part B) n=10 Participants Participants received placebo once weekly for four weeks by subcutaneous injection.	Dulaglutide (Part B) Participants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection.	Tirzepatide (Part C) Participants received either 0.5mg or 5mg or titrated doses of 5mg,5mg,10mg,10mg or 5mg,5mg,10mg,15mg Tirzepatide once weekly for four weeks by subcutaneous injection	Placebo (Part C) Participants received placebo once weekly for four weeks by subcutaneous injection.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part C	4770 Hour * nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 30	50500 Hour * nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 20	41900 Hour * nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 26	37990 Hour * nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 21	—	—	—

SECONDARY outcome

Timeframe: Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 2

Population: All randomized participants in part C who received at least one dose of Tirzepatide and had evaluable day 2 PD data.

PD: Glucose area under the concentration versus time curve from time 0 to 2 hours (AUC\[0-2h\]) in Part C. Ratio to Baseline (Day -1) AUC (0-2h).

Outcome measures

Outcome measures
Measure	Tirzepatide (Part A) n=9 Participants Participants received escalating doses of either 0.25mg or 0.5mg or 1mg, or 2.5mg or 5mg or 8mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Placebo (Part A) n=9 Participants Participants received placebo once weekly for four weeks by subcutaneous injection.	Tirzepatide (Part B) n=12 Participants Participants received escalating doses of either 0.5mg or 1.5mg or 4.5mg or titrated doses of 5mg, 5mg, 8mg and 10mg once weekly for four weeks by subcutaneous injection.	Placebo (Part B) n=12 Participants Participants received placebo once weekly for four weeks by subcutaneous injection.	Dulaglutide (Part B) Participants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection.	Tirzepatide (Part C) Participants received either 0.5mg or 5mg or titrated doses of 5mg,5mg,10mg,10mg or 5mg,5mg,10mg,15mg Tirzepatide once weekly for four weeks by subcutaneous injection	Placebo (Part C) Participants received placebo once weekly for four weeks by subcutaneous injection.
Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 2 to Baseline (Part C)	0.99 ratio Interval 0.79 to 1.11	0.72 ratio Interval 0.58 to 0.81	0.65 ratio Interval 0.53 to 0.73	0.73 ratio Interval 0.59 to 0.81	—	—	—

SECONDARY outcome

Timeframe: Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 23

Population: All randomized participants in part C who received at least one dose of Tirzepatide and had evaluable day 23 PD data.

PD: Glucose area under the concentration versus time curve from time 0 to 2 hours (AUC\[0-2h\]) in Part C. Ratio to Baseline (Day -1) AUC (0-2h).

Outcome measures

Outcome measures
Measure	Tirzepatide (Part A) n=9 Participants Participants received escalating doses of either 0.25mg or 0.5mg or 1mg, or 2.5mg or 5mg or 8mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Placebo (Part A) n=7 Participants Participants received placebo once weekly for four weeks by subcutaneous injection.	Tirzepatide (Part B) n=12 Participants Participants received escalating doses of either 0.5mg or 1.5mg or 4.5mg or titrated doses of 5mg, 5mg, 8mg and 10mg once weekly for four weeks by subcutaneous injection.	Placebo (Part B) n=11 Participants Participants received placebo once weekly for four weeks by subcutaneous injection.	Dulaglutide (Part B) Participants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection.	Tirzepatide (Part C) Participants received either 0.5mg or 5mg or titrated doses of 5mg,5mg,10mg,10mg or 5mg,5mg,10mg,15mg Tirzepatide once weekly for four weeks by subcutaneous injection	Placebo (Part C) Participants received placebo once weekly for four weeks by subcutaneous injection.
Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 23 to Baseline (Part C)	0.96 ratio Interval 0.83 to 1.16	0.61 ratio Interval 0.52 to 0.75	0.58 ratio Interval 0.51 to 0.7	0.57 ratio Interval 0.5 to 0.69	—	—	—

Adverse Events

Part A - Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part A - 0.25mg Tirzepatide

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part A - 0.5mg Tirzepatide

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Part A - 1mg Tirzepatide

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part A - 2.5mg Tirzepatide

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part A - 5mg Tirzepatide

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part A - 8mg Tirzepatide

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part B - Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part B - 1.5mg Dulaglutide

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part B - 0.5mg Tirzepatide

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part B - 1.5mg Tirzepatide

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part B - 4.5mg Tirzepatide

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part B - 5, 5, 8,10mg Tirzepatide

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part C - Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part C - 0.5mg Tirzepatide

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part C - 5mg Tirzepatide

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part C - 5, 5, 10,10mg Tirzepatide

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Part C - 5, 5, 10,15mg Tirzepatide

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A - Placebo n=14 participants at risk Participants received placebo by subcutaneous (SC) injection.	Part A - 0.25mg Tirzepatide n=6 participants at risk Participants received 0.25mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part A - 0.5mg Tirzepatide n=12 participants at risk Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part A - 1mg Tirzepatide n=5 participants at risk Participants received 1mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part A - 2.5mg Tirzepatide n=6 participants at risk Participants received 2.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part A - 5mg Tirzepatide n=6 participants at risk Participants received 5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part A - 8mg Tirzepatide n=7 participants at risk Participants received 8mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part B - Placebo n=4 participants at risk Participants received placebo by subcutaneous injection.	Part B - 1.5mg Dulaglutide n=4 participants at risk Participants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection.	Part B - 0.5mg Tirzepatide n=6 participants at risk Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part B - 1.5mg Tirzepatide n=6 participants at risk Participants received 1.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part B - 4.5mg Tirzepatide n=6 participants at risk Participants received 4.5mg Tirzepatide once weekly for four weeks by subcutaneous injections.	Part B - 5, 5, 8,10mg Tirzepatide n=7 participants at risk Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 8mg QW followed by 10mg QW.	Part C - Placebo n=11 participants at risk Participants received placebo by subcutaneous injection.	Part C - 0.5mg Tirzepatide n=9 participants at risk Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part C - 5mg Tirzepatide n=9 participants at risk Participants received 5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part C - 5, 5, 10,10mg Tirzepatide n=12 participants at risk Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 10mg QW.	Part C - 5, 5, 10,15mg Tirzepatide n=12 participants at risk Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 15mg QW.
Cardiac disorders Atrioventricular block second degree	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 1/4 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.

Other adverse events

Other adverse events
Measure	Part A - Placebo n=14 participants at risk Participants received placebo by subcutaneous (SC) injection.	Part A - 0.25mg Tirzepatide n=6 participants at risk Participants received 0.25mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part A - 0.5mg Tirzepatide n=12 participants at risk Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part A - 1mg Tirzepatide n=5 participants at risk Participants received 1mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part A - 2.5mg Tirzepatide n=6 participants at risk Participants received 2.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part A - 5mg Tirzepatide n=6 participants at risk Participants received 5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part A - 8mg Tirzepatide n=7 participants at risk Participants received 8mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part B - Placebo n=4 participants at risk Participants received placebo by subcutaneous injection.	Part B - 1.5mg Dulaglutide n=4 participants at risk Participants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection.	Part B - 0.5mg Tirzepatide n=6 participants at risk Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part B - 1.5mg Tirzepatide n=6 participants at risk Participants received 1.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part B - 4.5mg Tirzepatide n=6 participants at risk Participants received 4.5mg Tirzepatide once weekly for four weeks by subcutaneous injections.	Part B - 5, 5, 8,10mg Tirzepatide n=7 participants at risk Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 8mg QW followed by 10mg QW.	Part C - Placebo n=11 participants at risk Participants received placebo by subcutaneous injection.	Part C - 0.5mg Tirzepatide n=9 participants at risk Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part C - 5mg Tirzepatide n=9 participants at risk Participants received 5mg Tirzepatide once weekly for four weeks by subcutaneous injection.	Part C - 5, 5, 10,10mg Tirzepatide n=12 participants at risk Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 10mg QW.	Part C - 5, 5, 10,15mg Tirzepatide n=12 participants at risk Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 15mg QW.
General disorders Local swelling	7.1% 1/14 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Medical device site pruritus	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	33.3% 2/6 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Cardiac disorders Palpitations	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	14.3% 1/7 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Cardiac disorders Supraventricular tachycardia	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	11.1% 1/9 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Eye disorders Conjunctival haemorrhage	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	11.1% 1/9 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Gastrointestinal disorders Abdominal distension	7.1% 1/14 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	50.0% 3/6 • Number of events 4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	28.6% 2/7 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	50.0% 2/4 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	66.7% 4/6 • Number of events 5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	14.3% 1/7 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	11.1% 1/9 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 2/12 • Number of events 3 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	58.3% 7/12 • Number of events 7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 2/12 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	14.3% 1/7 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Gastrointestinal disorders Constipation	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 2/12 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 1/4 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 3 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	28.6% 2/7 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	9.1% 1/11 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	11.1% 1/9 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	11.1% 1/9 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 3/12 • Number of events 7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	41.7% 5/12 • Number of events 5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 1/4 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 3/12 • Number of events 3 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Gastrointestinal disorders Eructation	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 1/4 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	33.3% 4/12 • Number of events 4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Gastrointestinal disorders Faeces soft	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Gastrointestinal disorders Flatulence	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	11.1% 1/9 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	41.7% 5/12 • Number of events 5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Gastrointestinal disorders Gingival pain	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 1/4 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Gastrointestinal disorders Nausea	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	57.1% 4/7 • Number of events 4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 1/4 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 1/4 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	33.3% 2/6 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	42.9% 3/7 • Number of events 4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	11.1% 1/9 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	11.1% 1/9 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	50.0% 6/12 • Number of events 7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Gastrointestinal disorders Vomiting	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	33.3% 2/6 • Number of events 5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	42.9% 3/7 • Number of events 13 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 1/4 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	42.9% 3/7 • Number of events 29 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	11.1% 1/9 • Number of events 3 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	75.0% 9/12 • Number of events 33 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Administration site bruise	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Application site dermatitis	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	9.1% 1/11 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 2/12 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Application site erythema	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	20.0% 1/5 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 1/4 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	33.3% 2/6 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Application site pruritus	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Application site rash	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Application site reaction	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Asthenia	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Catheter site bruise	7.1% 1/14 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 2/12 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	20.0% 1/5 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	50.0% 2/4 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	14.3% 1/7 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	11.1% 1/9 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 2/12 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Catheter site erythema	7.1% 1/14 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 2/12 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	33.3% 2/6 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	14.3% 1/7 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	50.0% 2/4 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 1/4 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	14.3% 1/7 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Catheter site pain	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Catheter site phlebitis	7.1% 1/14 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Catheter site pruritus	7.1% 1/14 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Catheter site swelling	7.1% 1/14 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	33.3% 2/6 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	14.3% 1/7 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Catheter site urticaria	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Chest discomfort	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 1/4 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Chills	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Feeling hot	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	28.6% 2/7 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	28.6% 2/7 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Injection site bruising	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Injection site erythema	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	14.3% 1/7 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Injection site haematoma	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	11.1% 1/9 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Injection site pain	7.1% 1/14 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 3/12 • Number of events 3 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	20.0% 1/5 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Injection site pruritus	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Injection site swelling	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	14.3% 1/7 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Pain	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Pyrexia	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 1/4 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Vessel puncture site bruise	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	33.3% 4/12 • Number of events 4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	14.3% 1/7 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 1/4 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 1/4 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 2/12 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Vessel puncture site erythema	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
General disorders Vessel puncture site pain	7.1% 1/14 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Infections and infestations Nasopharyngitis	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Infections and infestations Rhinitis	7.1% 1/14 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	20.0% 1/5 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Infections and infestations Upper respiratory tract infection	14.3% 2/14 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	33.3% 4/12 • Number of events 4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	14.3% 1/7 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 1/4 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	9.1% 1/11 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	22.2% 2/9 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 2/12 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Injury, poisoning and procedural complications Post procedural diarrhoea	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	9.1% 1/11 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Injury, poisoning and procedural complications Procedural dizziness	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	11.1% 1/9 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Injury, poisoning and procedural complications Procedural nausea	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	11.1% 1/9 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Injury, poisoning and procedural complications Procedural vomiting	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	11.1% 1/9 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Investigations Alanine aminotransferase increased	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Investigations Hepatic enzyme increased	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Investigations Lipase abnormal	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	11.1% 1/9 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Investigations Lipase increased	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	14.3% 1/7 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Investigations Pancreatic enzymes increased	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	9.1% 1/11 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Investigations Weight decreased	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 2/12 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 2/12 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Metabolism and nutrition disorders Decreased appetite	7.1% 1/14 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	66.7% 4/6 • Number of events 6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	85.7% 6/7 • Number of events 7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 1/4 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	83.3% 5/6 • Number of events 9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	57.1% 4/7 • Number of events 9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	9.1% 1/11 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	22.2% 2/9 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	66.7% 6/9 • Number of events 7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	41.7% 5/12 • Number of events 11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	91.7% 11/12 • Number of events 11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	14.3% 1/7 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Musculoskeletal and connective tissue disorders Neck pain	7.1% 1/14 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	14.3% 1/7 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Nervous system disorders Dizziness	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	14.3% 1/7 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 1/4 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	33.3% 2/6 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Nervous system disorders Headache	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	33.3% 2/6 • Number of events 4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	14.3% 1/7 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 1/4 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	28.6% 2/7 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	11.1% 1/9 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 2/12 • Number of events 3 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 3/12 • Number of events 3 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Nervous system disorders Lethargy	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	14.3% 1/7 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Psychiatric disorders Food aversion	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Psychiatric disorders Initial insomnia	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Renal and urinary disorders Haematuria	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	11.1% 1/9 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Renal and urinary disorders Pollakiuria	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	14.3% 1/7 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 2/12 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	25.0% 1/4 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	28.6% 2/7 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 2/12 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	20.0% 1/5 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Skin and subcutaneous tissue disorders Milia	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Skin and subcutaneous tissue disorders Pruritus	7.1% 1/14 • Number of events 2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Skin and subcutaneous tissue disorders Skin tightness	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Surgical and medical procedures Hysterectomy	— 0/0 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	— 0/0 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	— 0/0 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	— 0/0 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	— 0/0 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	— 0/0 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	— 0/0 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	— 0/0 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	— 0/0 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	— 0/0 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	16.7% 1/6 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/2 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.
Vascular disorders Orthostatic hypotension	0.00% 0/14 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/5 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/4 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/6 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/7 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/11 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/9 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	8.3% 1/12 • Number of events 1 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/12 • Baseline to end of study (Up to 57 days) All randomized participants who received at least 1 dose of the study drug.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60