Trial Outcomes & Findings for A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis (NCT NCT01240915)

Last Updated: 2016-02-23

Results Overview

Modified Baron Score is an instrument designed to measure endoscopic activity of ulcerative colitis. It classifies the mucosal inflammation in 4 grades (0=normal, 1=granular mucosa with an abnormal vascular pattern, 2=friable mucosa, 3=microulceration with spontaneous bleeding, 4=gross ulceration with spontaneous bleeding).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

105 participants

Primary outcome timeframe

Baseline and Week 8

Results posted on

2016-02-23

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1: Placebo, MultiStem 300 Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.	Cohort 2: Placebo, MultiStem 750 Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 1: MultiStem 300, Placebo Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Overall Study STARTED	2	3	2	4	6	23	25	19	21
Overall Study COMPLETED	0	2	2	1	2	13	17	15	13
Overall Study NOT COMPLETED	2	1	0	3	4	10	8	4	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Placebo, MultiStem 300 Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.	Cohort 2: Placebo, MultiStem 750 Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Overall Study Adverse Event	0	0	1	0	2	0	0	1
Overall Study Lost to Follow-up	0	0	0	1	1	0	1	1
Overall Study Withdrawal by Subject	2	1	2	0	4	2	3	3
Overall Study Other	0	0	0	2	0	0	0	0
Overall Study Insufficient Clinical Response	0	0	0	1	3	6	0	3

Baseline Characteristics

A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Placebo, MultiStem 300 n=2 Participants Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.	Cohort 2: Placebo, MultiStem 750 n=3 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 1: MultiStem 300 or MultiStem 300 (x3), Placebo n=6 Participants Participants received either a single dose of MultiStem 300 Million Cells infusion on Day 1 or 3 doses on Day 1, Week 1, and Week 2; followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo n=6 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 n=23 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo n=25 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 n=19 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo n=21 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Total n=105 Participants Total of all reporting groups
Age, Continuous	61.0 years STANDARD_DEVIATION 7.1 • n=5 Participants	52.0 years STANDARD_DEVIATION 7.0 • n=7 Participants	49.3 years STANDARD_DEVIATION 14.1 • n=5 Participants	40.0 years STANDARD_DEVIATION 14.0 • n=4 Participants	43.4 years STANDARD_DEVIATION 12.8 • n=21 Participants	38.8 years STANDARD_DEVIATION 13.4 • n=8 Participants	39.8 years STANDARD_DEVIATION 12.5 • n=8 Participants	42.5 years STANDARD_DEVIATION 15.7 • n=24 Participants	42.2 years STANDARD_DEVIATION 13.7 • n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	7 Participants n=21 Participants	12 Participants n=8 Participants	3 Participants n=8 Participants	7 Participants n=24 Participants	36 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	16 Participants n=21 Participants	13 Participants n=8 Participants	16 Participants n=8 Participants	14 Participants n=24 Participants	69 Participants n=42 Participants

PRIMARY outcome

Timeframe: Baseline and Week 8

Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint. Baseline observation carried forward (BOCF) was used for treatment failures.

Outcome measures

Outcome measures
Measure	Pooled MultiStem n=48 Participants All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.	Pooled Placebo n=40 Participants All participants who received placebo infusion on Day 1 in Cohort 3.	Cohort 1: MultiStem 300, Placebo Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Change From Baseline in Endoscopic Score (as Measured by Modified Baron Score) at Week 8 Baseline	3.13 scores on a scale Standard Deviation 1.104	3.10 scores on a scale Standard Deviation 1.128	—	—	—	—	—	—	—
Change From Baseline in Endoscopic Score (as Measured by Modified Baron Score) at Week 8 Change at Week 8	0.10 scores on a scale Standard Deviation 1.134	-0.30 scores on a scale Standard Deviation 1.091	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and Week 4

Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.

Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.

Outcome measures

Outcome measures
Measure	Pooled MultiStem n=48 Participants All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.	Pooled Placebo n=40 Participants All participants who received placebo infusion on Day 1 in Cohort 3.	Cohort 1: MultiStem 300, Placebo Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Change From Baseline in Rectal Bleeding Mayo Subscore at Week 4 Baseline	1.42 scores on a scale Standard Deviation 0.942	1.23 scores on a scale Standard Deviation 0.832	—	—	—	—	—	—	—
Change From Baseline in Rectal Bleeding Mayo Subscore at Week 4 Change at Week 4	-0.44 scores on a scale Standard Deviation 0.943	-0.38 scores on a scale Standard Deviation 0.705	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and Week 8

Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.

Outcome measures

Outcome measures
Measure	Pooled MultiStem n=48 Participants All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.	Pooled Placebo n=40 Participants All participants who received placebo infusion on Day 1 in Cohort 3.	Cohort 1: MultiStem 300, Placebo Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Change From Baseline in Rectal Bleeding Mayo Subscore at Week 8	-0.46 scores on a scale Standard Deviation 1.051	-0.43 scores on a scale Standard Deviation 0.874	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline up to Week 52

Population: The safety analysis population consisted of all participants who received at least 1 dose of study medication.

An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.

Outcome measures

Outcome measures
Measure	Pooled MultiStem n=2 Participants All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.	Pooled Placebo n=3 Participants All participants who received placebo infusion on Day 1 in Cohort 3.	Cohort 1: MultiStem 300, Placebo n=2 Participants Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo n=4 Participants Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo n=6 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 n=23 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo n=25 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 n=19 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo n=21 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	2 participants	3 participants	0 participants	4 participants	5 participants	20 participants	18 participants	16 participants	19 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	1 participants	0 participants	0 participants	3 participants	0 participants	7 participants	4 participants	5 participants	4 participants

PRIMARY outcome

Timeframe: Baseline up to Week 52

Population: The safety analysis population consisted of all participants who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Pooled MultiStem n=2 Participants All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.	Pooled Placebo n=3 Participants All participants who received placebo infusion on Day 1 in Cohort 3.	Cohort 1: MultiStem 300, Placebo n=2 Participants Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo n=4 Participants Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo n=6 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 n=23 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo n=25 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 n=19 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo n=21 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) BLOOD AND LYMPHATIC SYSTEM DISORDERS	0 participants	0 participants	0 participants	0 participants	0 participants	5 participants	0 participants	3 participants	4 participants
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) CARDIAC DISORDERS	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	1 participants	1 participants
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) EAR AND LABYRINTH DISORDERS	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	1 participants	1 participants
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) EYE DISORDERS	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	3 participants
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) GASTROINTESTINAL DISORDERS	2 participants	1 participants	0 participants	2 participants	4 participants	13 participants	10 participants	11 participants	12 participants
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) GENERAL DISORDERS	2 participants	1 participants	0 participants	3 participants	1 participants	8 participants	5 participants	5 participants	6 participants
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) IMMUNE SYSTEM DISORDERS	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	2 participants	0 participants	0 participants
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) INFECTIONS AND INFESTATIONS	1 participants	1 participants	0 participants	1 participants	1 participants	10 participants	9 participants	9 participants	7 participants
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) INJURY, POISONING AND PROCEDURAL COMPLICATIONS	0 participants	1 participants	0 participants	1 participants	0 participants	2 participants	2 participants	2 participants	1 participants
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) INVESTIGATIONS	0 participants	1 participants	0 participants	0 participants	1 participants	4 participants	1 participants	5 participants	3 participants
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) METABOLISM AND NUTRITION DISORDERS	0 participants	0 participants	0 participants	1 participants	0 participants	2 participants	0 participants	1 participants	1 participants
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	0 participants	2 participants	0 participants	0 participants	2 participants	6 participants	5 participants	2 participants	1 participants
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) NERVOUS SYSTEM DISORDERS	0 participants	1 participants	0 participants	1 participants	1 participants	1 participants	3 participants	9 participants	6 participants
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) PSYCHIATRIC DISORDERS	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	1 participants	3 participants	2 participants
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) RENAL AND URINARY DISORDERS	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	1 participants	0 participants	0 participants
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	1 participants	1 participants	0 participants	0 participants	0 participants	5 participants	5 participants	1 participants	4 participants
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) SKIN AND SUBCUTANEOUS TISSUE DISORDERS	0 participants	0 participants	0 participants	1 participants	1 participants	4 participants	4 participants	3 participants	2 participants
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) SURGICAL AND MEDICAL PROCEDURES	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	1 participants	0 participants
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) VASCULAR DISORDERS	0 participants	0 participants	0 participants	0 participants	2 participants	1 participants	1 participants	2 participants	1 participants
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) ENDOCRINE DISORDERS	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	1 participants	0 participants

PRIMARY outcome

Timeframe: Baseline up to Week 52

Population: The safety analysis population consisted of all participants who received at least 1 dose of study medication.

The intensity grades were defined as follows: mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function; severe=interferes significantly with participant's usual function.

Outcome measures

Outcome measures
Measure	Pooled MultiStem n=2 Participants All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.	Pooled Placebo n=3 Participants All participants who received placebo infusion on Day 1 in Cohort 3.	Cohort 1: MultiStem 300, Placebo n=2 Participants Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo n=4 Participants Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo n=6 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 n=23 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo n=25 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 n=19 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo n=21 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Number of Treatment-Emergent AEs by Severity Mild AEs	6 adverse events	16 adverse events	0 adverse events	8 adverse events	13 adverse events	61 adverse events	35 adverse events	56 adverse events	48 adverse events
Number of Treatment-Emergent AEs by Severity Moderate AEs	4 adverse events	0 adverse events	0 adverse events	5 adverse events	2 adverse events	33 adverse events	31 adverse events	21 adverse events	17 adverse events
Number of Treatment-Emergent AEs by Severity Severe AEs	1 adverse events	0 adverse events	0 adverse events	4 adverse events	0 adverse events	13 adverse events	8 adverse events	4 adverse events	3 adverse events

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 16

Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.

Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.

Outcome measures

Outcome measures
Measure	Pooled MultiStem n=2 Participants All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.	Pooled Placebo n=3 Participants All participants who received placebo infusion on Day 1 in Cohort 3.	Cohort 1: MultiStem 300, Placebo n=2 Participants Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo n=4 Participants Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo n=6 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 n=23 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo n=25 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 n=19 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo n=21 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16 Change at Week 12 (n=0,0,0,0,0,22,25,17,19)	NA scores on a scale Standard Deviation NA No participants were analyzed in this arm at Week 12.	NA scores on a scale Standard Deviation NA No participants were analyzed in this arm at Week 12.	NA scores on a scale Standard Deviation NA No participants were analyzed in this arm at Week 12.	NA scores on a scale Standard Deviation NA No participants were analyzed in this arm at Week 12.	NA scores on a scale Standard Deviation NA No participants were analyzed in this arm at Week 12.	-0.77 scores on a scale Standard Deviation 0.869	-0.64 scores on a scale Standard Deviation 1.114	-0.53 scores on a scale Standard Deviation 0.874	-0.47 scores on a scale Standard Deviation 0.905
Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16 Change at Week 16 (n=2,3,2,4,6,21,24,17,19)	-1.50 scores on a scale Standard Deviation 0.707	-1.00 scores on a scale Standard Deviation 1.000	0.00 scores on a scale Standard Deviation 0.000	0.00 scores on a scale Standard Deviation 0.816	-0.60 scores on a scale Standard Deviation 1.140	-0.57 scores on a scale Standard Deviation 0.978	-0.92 scores on a scale Standard Deviation 1.100	-0.47 scores on a scale Standard Deviation 0.874	-0.58 scores on a scale Standard Deviation 0.838

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: The safety analysis population consisted of all participants who received at least 1 dose of study medication; n=the number of participants analyzed at that time point in the respective arms.

The total number of participants with laboratory test abnormalities with or without regard to baseline abnormality was assessed. Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, platelet count, white blood cell \[WBC\] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, erythrocyte sedimentation rate); chemistry (blood urea nitrogen and creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy (only if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase); other (follicle-stimulating hormone, human chorionic gonadotropin, stool microbiology, creatinine kinase, direct bilirubin, indirect bilirubin, gamma-glutamyl transferase, international normalized ratio.

Outcome measures

Outcome measures
Measure	Pooled MultiStem n=2 Participants All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.	Pooled Placebo n=3 Participants All participants who received placebo infusion on Day 1 in Cohort 3.	Cohort 1: MultiStem 300, Placebo n=2 Participants Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo n=4 Participants Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo n=6 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 n=23 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo n=25 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 n=19 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo n=21 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Number of Participants With Laboratory Test Abnormalities Normal/Abnormal Baseline(n=2,3,2,4,6,23,25,19,21)	2 participants	2 participants	1 participants	4 participants	4 participants	14 participants	20 participants	15 participants	17 participants
Number of Participants With Laboratory Test Abnormalities Normal Baseline (n=2,3,2,4,6,23,25,19,21)	2 participants	2 participants	1 participants	3 participants	4 participants	9 participants	16 participants	12 participants	13 participants
Number of Participants With Laboratory Test Abnormalities Abnormal Baseline (n=2,3,2,2,3,22,19,15,18)	1 participants	1 participants	1 participants	1 participants	2 participants	7 participants	4 participants	4 participants	6 participants

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The safety analysis population consisted of all participants who received at least 1 dose of study medication.

Vital signs assessment included pulse rate, systolic blood pressure (SBP) and diastolic blood pressure (DBP). Criteria for vital sign values meeting potential clinical concern included: SBP \<90 millimeters of mercury (mm Hg) and \>=30 mm Hg increase/decrease from baseline, DBP \<50 mm Hg and \>=20 mm Hg increase/decrease from baseline, pulse rate \<40 or \>120 beats per minute (bpm),

Outcome measures

Outcome measures
Measure	Pooled MultiStem n=2 Participants All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.	Pooled Placebo n=3 Participants All participants who received placebo infusion on Day 1 in Cohort 3.	Cohort 1: MultiStem 300, Placebo n=2 Participants Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo n=4 Participants Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo n=6 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 n=23 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo n=25 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 n=19 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo n=21 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Number of Participants With Potentially Clinically Significant Vital Signs Findings Supine SBP <90 mm Hg	0 participants	0 participants	0 participants	0 participants	2 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Vital Signs Findings Supine DBP <50 mm Hg	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Vital Signs Findings Supine Pulse Rate <40 bpm	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Vital Signs Findings Supine Pulse Rate >120 bpm	0 participants	0 participants	0 participants	0 participants	0 participants	3 participants	0 participants	1 participants	0 participants
Number of Participants With Potentially Clinically Significant Vital Signs Findings Supine SBP >=30 mm Hg Increase From Baseline	0 participants	0 participants	0 participants	1 participants	1 participants	1 participants	3 participants	1 participants	2 participants
Number of Participants With Potentially Clinically Significant Vital Signs Findings Supine DBP >=20 mm Hg Increase From Baseline	2 participants	0 participants	0 participants	1 participants	0 participants	3 participants	0 participants	2 participants	4 participants
Number of Participants With Potentially Clinically Significant Vital Signs Findings Supine SBP >=30 mm Hg Decrease From Baseline	0 participants	0 participants	0 participants	1 participants	0 participants	1 participants	1 participants	1 participants	1 participants
Number of Participants With Potentially Clinically Significant Vital Signs Findings Supine DBP >=20 mm Hg Decrease From Baseline	1 participants	1 participants	0 participants	0 participants	0 participants	6 participants	1 participants	3 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12 and 16

Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.

Fecal calprotectin, a very stable marker, is a 36kDa calcium and zinc binding protein which is neutrophil-derived. It represents 60% of cytosolic proteins in granulocytes and is a measurement of neutrophil migration to the gastrointestinal tract.

Outcome measures

Outcome measures
Measure	Pooled MultiStem n=2 Participants All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.	Pooled Placebo n=3 Participants All participants who received placebo infusion on Day 1 in Cohort 3.	Cohort 1: MultiStem 300, Placebo n=2 Participants Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo n=4 Participants Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo n=6 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 n=23 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo n=25 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 n=19 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo n=21 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 Baseline (n=2,3,1,4,5,21,23,19,20)	690.7549 fold change Geometric Coefficient of Variation 17	1189.8169 fold change Geometric Coefficient of Variation 22	739.2300 fold change Geometric Coefficient of Variation NA Only 1 participant was analyzed.	898.2758 fold change Geometric Coefficient of Variation 89	874.1363 fold change Geometric Coefficient of Variation 1462	576.5796 fold change Geometric Coefficient of Variation 237	476.1504 fold change Geometric Coefficient of Variation 222	513.2139 fold change Geometric Coefficient of Variation 208	821.1953 fold change Geometric Coefficient of Variation 220
Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 Change at Week 4 (n=2,3,1,3,5,20,21,18,19)	0.6297 fold change Geometric Coefficient of Variation 50	1.8680 fold change Geometric Coefficient of Variation 103	2.0264 fold change Geometric Coefficient of Variation NA Only 1 participant was analyzed.	2.0549 fold change Geometric Coefficient of Variation 112	1.0940 fold change Geometric Coefficient of Variation 91	1.2196 fold change Geometric Coefficient of Variation 158	0.8179 fold change Geometric Coefficient of Variation 314	1.0541 fold change Geometric Coefficient of Variation 166	0.6722 fold change Geometric Coefficient of Variation 193
Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 Change at Week 8 (n=1,2,1,3,2,18,20,17,20)	2.4504 fold change Geometric Coefficient of Variation NA Only 1 participant was analyzed.	2.4559 fold change Geometric Coefficient of Variation 51	2.6199 fold change Geometric Coefficient of Variation NA Only 1 participant was analyzed.	0.5744 fold change Geometric Coefficient of Variation 52	0.3282 fold change Geometric Coefficient of Variation 2	1.0704 fold change Geometric Coefficient of Variation 220	0.7462 fold change Geometric Coefficient of Variation 235	0.8598 fold change Geometric Coefficient of Variation 227	0.3479 fold change Geometric Coefficient of Variation 242
Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 Change at Week 12 (n=0,0,0,0,0,20,21,17,18)	NA fold change Geometric Coefficient of Variation NA No participants were analyzed in this arm at Week 12.	NA fold change Geometric Coefficient of Variation NA No participants were analyzed in this arm at Week 12.	NA fold change Geometric Coefficient of Variation NA No participants were analyzed in this arm at Week 12.	NA fold change Geometric Coefficient of Variation NA No participants were analyzed in this arm at Week 12.	NA fold change Geometric Coefficient of Variation NA No participants were analyzed in this arm at Week 12.	0.9947 fold change Geometric Coefficient of Variation 171	0.8269 fold change Geometric Coefficient of Variation 310	0.8788 fold change Geometric Coefficient of Variation 293	0.5279 fold change Geometric Coefficient of Variation 171
Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 Change at Week 16 (n=2,3,1,4,4,18,18,16,17)	2.1672 fold change Geometric Coefficient of Variation 49	0.7679 fold change Geometric Coefficient of Variation 32	1.1956 fold change Geometric Coefficient of Variation NA Only 1 participant was analyzed.	0.4459 fold change Geometric Coefficient of Variation 139	0.2474 fold change Geometric Coefficient of Variation 4517	0.6473 fold change Geometric Coefficient of Variation 277	0.8486 fold change Geometric Coefficient of Variation 149	0.5473 fold change Geometric Coefficient of Variation 309	0.5275 fold change Geometric Coefficient of Variation 243

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12 and 16

Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.

CRP is an acute-phase protein which provides an objective criterion of inflammatory activity. CRP has a short half-life (19 hours) and therefore rises early after the onset of inflammation and rapidly decreases after resolution of the inflammation. It is induced by interleukin-6, TNF-alpha and other pro-inflammatory cytokines that are produced within the intestinal lamina propria.

Outcome measures

Outcome measures
Measure	Pooled MultiStem n=2 Participants All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.	Pooled Placebo n=3 Participants All participants who received placebo infusion on Day 1 in Cohort 3.	Cohort 1: MultiStem 300, Placebo n=2 Participants Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo n=4 Participants Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo n=6 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 n=23 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo n=25 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 n=19 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo n=21 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 Baseline (n=2,3,2,4,6,22,25,19,20)	1.272 fold change Geometric Coefficient of Variation 45	1.527 fold change Geometric Coefficient of Variation 118	0.229 fold change Geometric Coefficient of Variation 34	0.578 fold change Geometric Coefficient of Variation 37	0.180 fold change Geometric Coefficient of Variation 74	0.613 fold change Geometric Coefficient of Variation 339	0.542 fold change Geometric Coefficient of Variation 236	0.397 fold change Geometric Coefficient of Variation 157	0.453 fold change Geometric Coefficient of Variation 297
Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 Change at Week 4 (n=2,3,2,3,6,21,25,18,20)	0.289 fold change Geometric Coefficient of Variation 9	0.555 fold change Geometric Coefficient of Variation 82	1.937 fold change Geometric Coefficient of Variation 42	1.285 fold change Geometric Coefficient of Variation 60	1.446 fold change Geometric Coefficient of Variation 54	0.891 fold change Geometric Coefficient of Variation 147	0.764 fold change Geometric Coefficient of Variation 140	0.999 fold change Geometric Coefficient of Variation 103	0.588 fold change Geometric Coefficient of Variation 132
Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 Change at Week 8 (n=1,3,1,3,5,21,25,19,20)	1.390 fold change Geometric Coefficient of Variation NA Only 1 participant was analyzed.	0.745 fold change Geometric Coefficient of Variation 49	2.331 fold change Geometric Coefficient of Variation NA Only 1 participant was analyzed.	1.172 fold change Geometric Coefficient of Variation 20	1.555 fold change Geometric Coefficient of Variation 31	1.189 fold change Geometric Coefficient of Variation 146	0.759 fold change Geometric Coefficient of Variation 207	1.200 fold change Geometric Coefficient of Variation 113	0.623 fold change Geometric Coefficient of Variation 150
Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 Change at Week 12 (n=0,0,0,0,0,21,24,17,18)	NA fold change Geometric Coefficient of Variation NA No participants were analyzed in this arm at Week 12.	NA fold change Geometric Coefficient of Variation NA No participants were analyzed in this arm at Week 12.	NA fold change Geometric Coefficient of Variation NA No participants were analyzed in this arm at Week 12.	NA fold change Geometric Coefficient of Variation NA No participants were analyzed in this arm at Week 12.	NA fold change Geometric Coefficient of Variation NA No participants were analyzed in this arm at Week 12.	0.937 fold change Geometric Coefficient of Variation 211	0.710 fold change Geometric Coefficient of Variation 365	0.782 fold change Geometric Coefficient of Variation 149	0.373 fold change Geometric Coefficient of Variation 155
Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 Change at Week 16 (n=2,3,2,4,5,20,24,17,18)	0.956 fold change Geometric Coefficient of Variation 164	0.481 fold change Geometric Coefficient of Variation 56	0.606 fold change Geometric Coefficient of Variation 248	0.869 fold change Geometric Coefficient of Variation 14	1.184 fold change Geometric Coefficient of Variation 54	0.776 fold change Geometric Coefficient of Variation 156	0.425 fold change Geometric Coefficient of Variation 176	0.612 fold change Geometric Coefficient of Variation 133	0.417 fold change Geometric Coefficient of Variation 197

SECONDARY outcome

Timeframe: Week 4, 8, 12 and 16

Mayo subscores for rectal bleeding range from 0 to 3 (0=no blood seen; 1=streaks of blood with stool less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes).

Outcome measures

Outcome measures
Measure	Pooled MultiStem n=2 Participants All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.	Pooled Placebo n=3 Participants All participants who received placebo infusion on Day 1 in Cohort 3.	Cohort 1: MultiStem 300, Placebo n=2 Participants Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo n=4 Participants Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo n=6 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 n=23 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo n=25 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 n=19 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo n=21 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 Week 4	50.0 percentage of participants	66.7 percentage of participants	50.0 percentage of participants	33.3 percentage of participants	40.0 percentage of participants	52.2 percentage of participants	28.0 percentage of participants	31.6 percentage of participants	42.9 percentage of participants
Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 Week 8	50.0 percentage of participants	66.7 percentage of participants	50.0 percentage of participants	33.3 percentage of participants	40.0 percentage of participants	47.8 percentage of participants	36.0 percentage of participants	31.6 percentage of participants	47.6 percentage of participants
Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 Week 12	NA percentage of participants No participants were analyzed in this arm at Week 12.	NA percentage of participants No participants were analyzed in this arm at Week 12.	NA percentage of participants No participants were analyzed in this arm at Week 12.	NA percentage of participants No participants were analyzed in this arm at Week 12.	NA percentage of participants No participants were analyzed in this arm at Week 12.	60.9 percentage of participants	40.0 percentage of participants	47.4 percentage of participants	42.9 percentage of participants
Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 Week 16	50.0 percentage of participants	100 percentage of participants	50.0 percentage of participants	50.0 percentage of participants	40.0 percentage of participants	47.8 percentage of participants	48.0 percentage of participants	36.8 percentage of participants	52.4 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Pooled MultiStem n=2 Participants All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.	Pooled Placebo n=3 Participants All participants who received placebo infusion on Day 1 in Cohort 3.	Cohort 1: MultiStem 300, Placebo n=2 Participants Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo n=4 Participants Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo n=6 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 n=23 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo n=25 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 n=19 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo n=21 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Percentage of Participants in Endoscopic Remission at Week 8	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	4.3 percentage of participants	4.0 percentage of participants	0 percentage of participants	9.5 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Clinical remission is defined as a total Mayo score of 2 points or lower, with no individual subscores exceeding 1 point.

Outcome measures

Outcome measures
Measure	Pooled MultiStem n=2 Participants All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.	Pooled Placebo n=3 Participants All participants who received placebo infusion on Day 1 in Cohort 3.	Cohort 1: MultiStem 300, Placebo n=2 Participants Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo n=4 Participants Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo n=6 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 n=23 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo n=25 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 n=19 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo n=21 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Percentage of Participants in Clinical Remission at Week 8	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	8.0 percentage of participants	0 percentage of participants	19.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12 and 16

Mayo subscores for rectal bleeding range from 0 to 3 (0=no blood seen; 1=streaks of blood with stool less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes). A decrease from baseline score indicates improvement.

Outcome measures

Outcome measures
Measure	Pooled MultiStem n=2 Participants All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.	Pooled Placebo n=3 Participants All participants who received placebo infusion on Day 1 in Cohort 3.	Cohort 1: MultiStem 300, Placebo n=2 Participants Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo n=4 Participants Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo n=6 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 n=23 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo n=25 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 n=19 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo n=21 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 Week 4	100 percentage of participants	66.7 percentage of participants	0 percentage of participants	0 percentage of participants	40.0 percentage of participants	43.5 percentage of participants	48.0 percentage of participants	21.1 percentage of participants	38.1 percentage of participants
Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 Week 8	100 percentage of participants	33.3 percentage of participants	0 percentage of participants	0 percentage of participants	40.0 percentage of participants	34.8 percentage of participants	48.0 percentage of participants	31.6 percentage of participants	47.6 percentage of participants
Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 Week 12	NA percentage of participants No participants were analyzed in this arm at Week 12.	NA percentage of participants No participants were analyzed in this arm at Week 12.	NA percentage of participants No participants were analyzed in this arm at Week 12.	NA percentage of participants No participants were analyzed in this arm at Week 12.	NA percentage of participants No participants were analyzed in this arm at Week 12.	54.5 percentage of participants	60.0 percentage of participants	41.2 percentage of participants	52.6 percentage of participants
Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 Week 16	100 percentage of participants	66.7 percentage of participants	0 percentage of participants	25.0 percentage of participants	60.0 percentage of participants	47.6 percentage of participants	58.3 percentage of participants	35.3 percentage of participants	47.4 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Endoscopic response is defined as a decrease in modified Baron endoscopic score from baseline of at least 2 points.

Outcome measures

Outcome measures
Measure	Pooled MultiStem n=2 Participants All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.	Pooled Placebo n=3 Participants All participants who received placebo infusion on Day 1 in Cohort 3.	Cohort 1: MultiStem 300, Placebo n=2 Participants Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo n=4 Participants Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo n=6 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 n=23 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo n=25 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 n=19 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo n=21 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Percentage of Participants With Endoscopic Response at Week 8	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	8.7 percentage of participants	8.0 percentage of participants	10.5 percentage of participants	19.0 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Clinical response is defined as a decrease in total Mayo score from baseline of at least 3 points and at least 30 percent (%), with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1.

Outcome measures

Outcome measures
Measure	Pooled MultiStem n=2 Participants All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.	Pooled Placebo n=3 Participants All participants who received placebo infusion on Day 1 in Cohort 3.	Cohort 1: MultiStem 300, Placebo n=2 Participants Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo n=4 Participants Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo n=6 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 n=23 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo n=25 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 n=19 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo n=21 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Percentage of Participants in Clinical Response at Week 8	50.0 percentage of participants	33.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	4.3 percentage of participants	24.0 percentage of participants	15.8 percentage of participants	42.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.

Mayo Score is an instrument designed to measure disease activity of ulcerative colitis, with total score ranging from 0 to 12. It consists of 4 subscores (stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy, and physician global assessment \[PGA\]), each graded from 0 to 3, with higher scores indicating more severe disease.

Outcome measures

Outcome measures
Measure	Pooled MultiStem n=2 Participants All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.	Pooled Placebo n=3 Participants All participants who received placebo infusion on Day 1 in Cohort 3.	Cohort 1: MultiStem 300, Placebo n=2 Participants Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo n=4 Participants Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo n=6 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 n=23 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo n=25 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 n=19 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo n=21 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Change From Baseline in Total Mayo Scores at Week 8 Baseline (n=2,3,2,4,6,23,25,19,21)	10.00 scores on a scale Standard Deviation 2.828	7.33 scores on a scale Standard Deviation 1.155	8.50 scores on a scale Standard Deviation 0.707	7.75 scores on a scale Standard Deviation 0.957	7.50 scores on a scale Standard Deviation 2.258	8.74 scores on a scale Standard Deviation 1.839	8.48 scores on a scale Standard Deviation 2.143	8.47 scores on a scale Standard Deviation 1.806	8.14 scores on a scale Standard Deviation 2.220
Change From Baseline in Total Mayo Scores at Week 8 Change at Week 8 (n=2,3,2,3,5,23,25,19,21)	-2.00 scores on a scale Standard Deviation 1.414 • Interval -1.84 to 0.33	0.00 scores on a scale Standard Deviation 2.646 • Interval -2.32 to -0.3	1.00 scores on a scale Standard Deviation 1.414 • Interval -2.11 to 0.18	0.33 scores on a scale Standard Deviation 0.577 • Interval -3.37 to -1.15	-0.60 scores on a scale Standard Deviation 0.894	-0.78 scores on a scale Standard Deviation 2.088	-1.20 scores on a scale Standard Deviation 2.872	-0.89 scores on a scale Standard Deviation 2.132	-2.00 scores on a scale Standard Deviation 2.683

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12 and 16

Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.

Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo Score ranges from 0 to 12 points. It consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease. A Partial Mayo Score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). Higher scores indicate more severe disease.

Outcome measures

Outcome measures
Measure	Pooled MultiStem n=2 Participants All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.	Pooled Placebo n=3 Participants All participants who received placebo infusion on Day 1 in Cohort 3.	Cohort 1: MultiStem 300, Placebo n=2 Participants Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo n=4 Participants Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo n=6 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 n=23 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo n=25 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 n=19 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo n=21 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 Baseline (n=2,3,2,4,6,23,25,19,21)	7.50 scores on a scale Standard Deviation 2.121	5.33 scores on a scale Standard Deviation 0.577	6.00 scores on a scale Standard Deviation 1.414	5.75 scores on a scale Standard Deviation 0.500	5.50 scores on a scale Standard Deviation 1.378	6.22 scores on a scale Standard Deviation 1.347	6.08 scores on a scale Standard Deviation 1.605	6.00 scores on a scale Standard Deviation 1.202	5.71 scores on a scale Standard Deviation 1.736
Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 Change at Week 4 (n=2,3,2,3,5,23,25,19,21)	-3.00 scores on a scale Standard Deviation 0.000 • Interval -1.84 to 0.33	-2.00 scores on a scale Standard Deviation 1.732 • Interval -2.32 to -0.3	-0.50 scores on a scale Standard Deviation 0.707 • Interval -2.11 to 0.18	0.67 scores on a scale Standard Deviation 1.528 • Interval -3.37 to -1.15	-0.40 scores on a scale Standard Deviation 1.140	-1.00 scores on a scale Standard Deviation 1.414	-0.96 scores on a scale Standard Deviation 1.791	-1.16 scores on a scale Standard Deviation 1.675	-1.24 scores on a scale Standard Deviation 1.895
Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 Change at Week 8 (n=2,3,2,3,5,23,25,19,21)	-2.00 scores on a scale Standard Deviation 1.414	-1.00 scores on a scale Standard Deviation 1.732	0.50 scores on a scale Standard Deviation 0.707	0.33 scores on a scale Standard Deviation 0.577	-0.80 scores on a scale Standard Deviation 1.095	-0.91 scores on a scale Standard Deviation 1.756	-1.12 scores on a scale Standard Deviation 2.472	-0.79 scores on a scale Standard Deviation 1.653	-1.62 scores on a scale Standard Deviation 2.037
Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 Change at Week 12 (n=0,0,0,0,0,22,25,17,19)	NA scores on a scale Standard Deviation NA No participants were analyzed in this arm at Week 12.	NA scores on a scale Standard Deviation NA No participants were analyzed in this arm at Week 12.	NA scores on a scale Standard Deviation NA No participants were analyzed in this arm at Week 12.	NA scores on a scale Standard Deviation NA No participants were analyzed in this arm at Week 12.	NA scores on a scale Standard Deviation NA No participants were analyzed in this arm at Week 12.	-1.91 scores on a scale Standard Deviation 1.974	-1.52 scores on a scale Standard Deviation 2.312	-2.06 scores on a scale Standard Deviation 2.135	-2.11 scores on a scale Standard Deviation 2.622
Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 Change at Week 16 (2,3,2,4,5,21,24,17,19)	-1.50 scores on a scale Standard Deviation 0.707	-3.00 scores on a scale Standard Deviation 3.000	-1.00 scores on a scale Standard Deviation 2.828	-1.25 scores on a scale Standard Deviation 3.403	-2.20 scores on a scale Standard Deviation 1.924	-1.86 scores on a scale Standard Deviation 2.081	-2.54 scores on a scale Standard Deviation 2.621	-2.41 scores on a scale Standard Deviation 2.181	-2.63 scores on a scale Standard Deviation 2.033

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.

A 15 to 25 centimeter (cm) biopsy sample of inflamed mucosal tissue was taken from the worst affected area and scored using the Riley Index. The Riley Index is a histologic scoring system for the assessment of the activity and severity of ulcerative colitis, ranging from 0 to 24. It consists of 6 histologic features (acute inflammatory cell infiltrate, crypt abscesses, mucin depletion, surface epithelial integrity, chronic inflammatory cell infiltrate, and crypt architectural irregularities), all scored on a 4-point scale (higher scores indicate more severe disease).

Outcome measures

Outcome measures
Measure	Pooled MultiStem n=2 Participants All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.	Pooled Placebo n=3 Participants All participants who received placebo infusion on Day 1 in Cohort 3.	Cohort 1: MultiStem 300, Placebo n=2 Participants Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo n=4 Participants Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo n=6 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 n=23 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo n=25 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 n=19 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo n=21 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Change From Baseline in Biopsy Histology Scores at Week 8 Baseline(n=2,3,2,4,5,22,24,18,21)	9.0 scores on a scale Standard Deviation 1.41	9.7 scores on a scale Standard Deviation 3.79	11.0 scores on a scale Standard Deviation 2.83	7.0 scores on a scale Standard Deviation 3.92	10.8 scores on a scale Standard Deviation 3.77	9.4 scores on a scale Standard Deviation 4.37	10.4 scores on a scale Standard Deviation 4.24	9.9 scores on a scale Standard Deviation 4.17	9.7 scores on a scale Standard Deviation 5.14
Change From Baseline in Biopsy Histology Scores at Week 8 Change at Week 4 (n=2,3,1,3,5,21,24,15,20)	-3.5 scores on a scale Standard Deviation 4.95 • Interval -1.84 to 0.33	1.3 scores on a scale Standard Deviation 1.15 • Interval -2.32 to -0.3	-3.0 scores on a scale Standard Deviation NA • Interval -2.11 to 0.18 No standard deviation was calculated, as only 1 participant was analyzed.	-1.0 scores on a scale Standard Deviation 1.73 • Interval -3.37 to -1.15	-0.4 scores on a scale Standard Deviation 2.07	1.4 scores on a scale Standard Deviation 4.63	-1.0 scores on a scale Standard Deviation 3.76	0.9 scores on a scale Standard Deviation 4.09	-1.5 scores on a scale Standard Deviation 4.80

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.

Patient-reported diary data assessed the number of bowel movements (BM) per day when not having a flare and the presence of blood in the stools (rectal bleeding \[RB\]), if any.

Outcome measures

Outcome measures
Measure	Pooled MultiStem n=2 Participants All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.	Pooled Placebo n=3 Participants All participants who received placebo infusion on Day 1 in Cohort 3.	Cohort 1: MultiStem 300, Placebo n=2 Participants Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo n=4 Participants Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo n=6 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 n=23 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo n=25 Participants Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 n=19 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo n=21 Participants Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 BM: Change at Week 8 (n=2,3,2,3,6,23,23,16,19)	-1.67 scores on a scale Standard Deviation 3.771	-0.86 scores on a scale Standard Deviation 3.517	3.18 scores on a scale Standard Deviation 0.758	0.17 scores on a scale Standard Deviation 2.754	0.41 scores on a scale Standard Deviation 2.131	-0.89 scores on a scale Standard Deviation 2.864	-1.15 scores on a scale Standard Deviation 2.833	0.18 scores on a scale Standard Deviation 2.531	-1.41 scores on a scale Standard Deviation 3.208
Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 RB: Baseline (n=2,3,2,4,6,23,25,19,21)	1.25 scores on a scale Standard Deviation 1.061	1.17 scores on a scale Standard Deviation 1.258	1.00 scores on a scale Standard Deviation 1.414	1.00 scores on a scale Standard Deviation 0.816	1.33 scores on a scale Standard Deviation 0.816	1.20 scores on a scale Standard Deviation 0.974	1.46 scores on a scale Standard Deviation 0.978	0.97 scores on a scale Standard Deviation 0.950	1.05 scores on a scale Standard Deviation 0.820
Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 BM: Baseline(n=2,3,2,4,6,23,25,19,21)	12.50 scores on a scale Standard Deviation 4.950	8.00 scores on a scale Standard Deviation 2.784	6.75 scores on a scale Standard Deviation 2.475	11.75 scores on a scale Standard Deviation 10.508	8.42 scores on a scale Standard Deviation 3.089	7.50 scores on a scale Standard Deviation 3.490	7.78 scores on a scale Standard Deviation 3.781	7.50 scores on a scale Standard Deviation 3.571	6.88 scores on a scale Standard Deviation 4.886
Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 BM: Change at Week 1 (n=2,3,2,4,5,23,25,19,21)	-1.60 scores on a scale Standard Deviation 2.263 • Interval -1.84 to 0.33	-1.89 scores on a scale Standard Deviation 1.766 • Interval -2.32 to -0.3	4.15 scores on a scale Standard Deviation 2.845 • Interval -2.11 to 0.18	-0.60 scores on a scale Standard Deviation 2.177 • Interval -3.37 to -1.15	0.40 scores on a scale Standard Deviation 1.300	-0.42 scores on a scale Standard Deviation 1.509	-0.59 scores on a scale Standard Deviation 1.657	-0.56 scores on a scale Standard Deviation 1.215	-0.81 scores on a scale Standard Deviation 3.421
Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 BM: Change at Week 4 (n=2,2,2,3,5,23,23,16,19	-1.43 scores on a scale Standard Deviation 3.435	-1.89 scores on a scale Standard Deviation 5.101	2.36 scores on a scale Standard Deviation 0.505	0.17 scores on a scale Standard Deviation 2.038	1.31 scores on a scale Standard Deviation 1.432	-0.81 scores on a scale Standard Deviation 2.088	0.28 scores on a scale Standard Deviation 3.956	-0.63 scores on a scale Standard Deviation 1.856	-1.08 scores on a scale Standard Deviation 2.575
Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 BM: Change at Week 12 (n=1,1,1,2,2,21,25,16,18)	0.14 scores on a scale Standard Deviation NA No standard deviation was calculated as only 1 participant was analyzed.	1.43 scores on a scale Standard Deviation NA No standard deviation was calculated as only 1 participant was analyzed.	1.57 scores on a scale Standard Deviation NA No standard deviation was calculated as only 1 participant was analyzed.	-1.68 scores on a scale Standard Deviation 2.374	0.00 scores on a scale Standard Deviation 0.000	-0.67 scores on a scale Standard Deviation 3.152	-0.59 scores on a scale Standard Deviation 4.426	-1.77 scores on a scale Standard Deviation 2.301	-2.02 scores on a scale Standard Deviation 3.502
Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 BM: Change at Week 16 (n=1,3,2,3,4,22,24,16,18)	0.00 scores on a scale Standard Deviation NA No standard deviation was calculated as only 1 participant was analyzed.	-2.51 scores on a scale Standard Deviation 3.716	1.72 scores on a scale Standard Deviation 0.596	-0.12 scores on a scale Standard Deviation 2.324	-2.45 scores on a scale Standard Deviation 2.208	-1.81 scores on a scale Standard Deviation 3.278	-2.17 scores on a scale Standard Deviation 3.523	-1.68 scores on a scale Standard Deviation 2.899	-1.86 scores on a scale Standard Deviation 3.616
Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 RB: Change at Week 1 (n=2,3,2,4,5,23,25,19,21)	-0.32 scores on a scale Standard Deviation 0.253	-1.00 scores on a scale Standard Deviation 1.167	-0.33 scores on a scale Standard Deviation 0.471	-0.12 scores on a scale Standard Deviation 0.158	-0.30 scores on a scale Standard Deviation 0.415	-0.36 scores on a scale Standard Deviation 0.697	-0.24 scores on a scale Standard Deviation 0.605	-0.05 scores on a scale Standard Deviation 0.574	-0.10 scores on a scale Standard Deviation 0.408
Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 RB: Change at Week 4 (n=2,2,2,3,5,23,23,16,19)	-0.75 scores on a scale Standard Deviation 0.354	-0.29 scores on a scale Standard Deviation 1.010	-0.25 scores on a scale Standard Deviation 0.354	0.14 scores on a scale Standard Deviation 0.378	-0.71 scores on a scale Standard Deviation 0.990	-0.34 scores on a scale Standard Deviation 0.883	-0.47 scores on a scale Standard Deviation 0.840	-0.27 scores on a scale Standard Deviation 0.738	-0.26 scores on a scale Standard Deviation 0.604
Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 RB: Change at Week 8 (n=2,3,2,3,6,22,23,13,20)	-0.75 scores on a scale Standard Deviation 0.354	-0.50 scores on a scale Standard Deviation 0.500	0.00 scores on a scale Standard Deviation 0.000	0.33 scores on a scale Standard Deviation 0.577	-0.47 scores on a scale Standard Deviation 1.035	-0.40 scores on a scale Standard Deviation 0.709	-0.51 scores on a scale Standard Deviation 0.805	-0.19 scores on a scale Standard Deviation 0.997	-0.51 scores on a scale Standard Deviation 0.967
Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 RB: Change at Week 12 (n=1,1,1,2,2,21,25,16,18)	-0.57 scores on a scale Standard Deviation NA No standard deviation was calculated as only 1 participant was analyzed.	0.00 scores on a scale Standard Deviation NA No standard deviation was calculated as only 1 participant was analyzed.	0.00 scores on a scale Standard Deviation NA No standard deviation was calculated as only 1 participant was analyzed.	0.00 scores on a scale Standard Deviation 0.000	0.00 scores on a scale Standard Deviation 0.000	-0.60 scores on a scale Standard Deviation 0.792	-0.49 scores on a scale Standard Deviation 1.084	-0.48 scores on a scale Standard Deviation 0.829	-0.39 scores on a scale Standard Deviation 0.783
Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 RB: Change at Week 16 (n=1,3,2,3,4,22,24,16,18)	-1.00 scores on a scale Standard Deviation NA No standard deviation was calculated as only 1 participant was analyzed.	-1.17 scores on a scale Standard Deviation 1.258	-0.10 scores on a scale Standard Deviation 0.141	0.33 scores on a scale Standard Deviation 0.577	-1.14 scores on a scale Standard Deviation 0.865	-0.41 scores on a scale Standard Deviation 0.936	-0.86 scores on a scale Standard Deviation 1.106	-0.41 scores on a scale Standard Deviation 0.838	-0.39 scores on a scale Standard Deviation 0.874

Adverse Events

Cohort 1: Placebo, MultiStem 300

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 2: Placebo, MultiStem 750

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 1: MultiStem 300, Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 1: MultiStem 300 (x3), Placebo

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 2: MultiStem 750, Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Cohort 3: MultiStem 750, MultiStem 750

Serious events: 7 serious events

Other events: 18 other events

Deaths: 0 deaths

Cohort 3: MultiStem 750, Placebo

Serious events: 4 serious events

Other events: 16 other events

Deaths: 0 deaths

Cohort 3: Placebo, MultiStem 750

Serious events: 5 serious events

Other events: 15 other events

Deaths: 0 deaths

Cohort 3: Placebo, Placebo

Serious events: 4 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Placebo, MultiStem 300 n=2 participants at risk Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.	Cohort 2: Placebo, MultiStem 750 n=3 participants at risk Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 1: MultiStem 300, Placebo n=2 participants at risk Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo n=4 participants at risk Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo n=6 participants at risk Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 n=23 participants at risk Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo n=25 participants at risk Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 n=19 participants at risk Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo n=21 participants at risk Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Cardiac disorders Ventricular tachycardia	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.8% 1/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Gastrointestinal disorders Colitis	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	25.0% 1/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.0% 1/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Gastrointestinal disorders Colitis ulcerative	50.0% 1/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	25.0% 1/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	21.7% 5/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.0% 1/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	10.5% 2/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	14.3% 3/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Gastrointestinal disorders Nausea	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Gastrointestinal disorders Vomiting	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Immune system disorders Hypersensitivity	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	25.0% 1/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Infections and infestations Abdominal abscess	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Infections and infestations Clostridium difficile colitis	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.8% 1/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Infections and infestations Clostridium difficile infection	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	8.0% 2/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Infections and infestations Gastroenteritis	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.0% 1/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Infections and infestations Pelvic sepsis	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Infections and infestations Perirectal abscess	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Infections and infestations Pneumonia	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Nervous system disorders Epilepsy	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Nervous system disorders Superior sagittal sinus thrombosis	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.8% 1/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Vascular disorders Diastolic hypertension	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.

Other adverse events

Other adverse events
Measure	Cohort 1: Placebo, MultiStem 300 n=2 participants at risk Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.	Cohort 2: Placebo, MultiStem 750 n=3 participants at risk Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 1: MultiStem 300, Placebo n=2 participants at risk Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 1: MultiStem 300 (x3), Placebo n=4 participants at risk Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.	Cohort 2: MultiStem 750, Placebo n=6 participants at risk Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: MultiStem 750, MultiStem 750 n=23 participants at risk Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: MultiStem 750, Placebo n=25 participants at risk Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.	Cohort 3: Placebo, MultiStem 750 n=19 participants at risk Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.	Cohort 3: Placebo, Placebo n=21 participants at risk Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	25.0% 1/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Gastrointestinal disorders Nausea	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	33.3% 2/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	13.0% 3/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.0% 1/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	9.5% 2/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	8.7% 2/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	17.4% 4/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	10.5% 2/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	14.3% 3/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Cardiac disorders Tachycardia	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Ear and labyrinth disorders Vertigo	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.8% 1/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Endocrine disorders Cushingoid	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.0% 1/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	13.0% 3/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	8.0% 2/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	9.5% 2/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.0% 1/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Gastrointestinal disorders Abdominal tenderness	50.0% 1/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	16.7% 1/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	21.7% 5/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	8.0% 2/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	15.8% 3/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	23.8% 5/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Gastrointestinal disorders Defaecation urgency	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	16.7% 1/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Gastrointestinal disorders Diarrhoea	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	13.0% 3/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Gastrointestinal disorders Dyspepsia	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.8% 1/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Gastrointestinal disorders Gastritis	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Gastrointestinal disorders Gastrooesophageal reflux disease	50.0% 1/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Gastrointestinal disorders Haematochezia	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	33.3% 1/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.0% 1/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Gastrointestinal disorders Painful defaecation	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Gastrointestinal disorders Perianal erythema	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	25.0% 1/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Gastrointestinal disorders Tongue disorder	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	33.3% 1/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Gastrointestinal disorders Vomiting	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.0% 1/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	10.5% 2/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
General disorders Asthenia	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	25.0% 1/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	13.0% 3/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
General disorders Chest discomfort	50.0% 1/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	16.7% 1/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	10.5% 2/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.8% 1/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
General disorders Chest pain	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	33.3% 1/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.0% 1/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.8% 1/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
General disorders Chills	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	33.3% 1/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	50.0% 2/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
General disorders Fatigue	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	8.7% 2/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	12.0% 3/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	9.5% 2/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
General disorders Influenza like illness	50.0% 1/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.0% 1/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
General disorders Oedema peripheral	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	9.5% 2/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
General disorders Pain	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	33.3% 1/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
General disorders Pyrexia	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	75.0% 3/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	8.7% 2/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	8.0% 2/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	9.5% 2/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Infections and infestations Bacteriuria	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Infections and infestations Bronchitis	50.0% 1/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Infections and infestations Cellulitis	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Infections and infestations Gastroenteritis	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Infections and infestations Influenza	50.0% 1/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Infections and infestations Nasopharyngitis	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	8.7% 2/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.0% 1/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	26.3% 5/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	19.0% 4/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Infections and infestations Pharyngitis	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Infections and infestations Sinusitis	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	33.3% 1/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	13.0% 3/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	8.0% 2/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Infections and infestations Upper respiratory tract infection	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	33.3% 1/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	25.0% 1/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	16.7% 1/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	8.7% 2/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	8.0% 2/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.8% 1/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Infections and infestations Urinary tract infection	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	25.0% 1/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	8.7% 2/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	8.0% 2/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Injury, poisoning and procedural complications Contusion	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	33.3% 1/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Injury, poisoning and procedural complications Fall	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	33.3% 1/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Injury, poisoning and procedural complications Incision site pain	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	25.0% 1/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Injury, poisoning and procedural complications Laceration	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.0% 1/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Injury, poisoning and procedural complications Skeletal injury	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	33.3% 1/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Investigations Antibody test	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Investigations Bacterial test	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	16.7% 1/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Investigations Blood albumin decreased	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Investigations Blood bilirubin increased	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Investigations Blood glucose increased	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Investigations Blood urine present	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	33.3% 1/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Investigations C-reactive protein increased	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Investigations Cold agglutinins	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Investigations Heart rate increased	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	16.7% 1/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Investigations Prostatic specific antigen increased	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	— 0/0 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/1 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/16 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/13 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/16 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	7.1% 1/14 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Investigations Weight decreased	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	8.7% 2/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.8% 1/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Vascular disorders Hypertension	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	13.0% 3/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.8% 1/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	33.3% 1/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	16.7% 1/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.0% 1/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	33.3% 1/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	8.0% 2/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	16.7% 1/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	13.0% 3/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.0% 1/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	33.3% 1/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.0% 1/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	16.7% 1/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Nervous system disorders Amnesia	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Nervous system disorders Dizziness	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	33.3% 1/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	16.7% 1/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.0% 1/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	10.5% 2/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Nervous system disorders Epilepsy	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Nervous system disorders Headache	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	12.0% 3/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	36.8% 7/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	28.6% 6/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Nervous system disorders Lethargy	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	25.0% 1/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Nervous system disorders Paraesthesia	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	10.5% 2/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Psychiatric disorders Anxiety	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.0% 1/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	15.8% 3/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Psychiatric disorders Confusional state	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Psychiatric disorders Depression	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	9.5% 2/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Psychiatric disorders Insomnia	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.0% 1/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.8% 1/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Respiratory, thoracic and mediastinal disorders Cough	50.0% 1/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	33.3% 1/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	13.0% 3/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	12.0% 3/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	50.0% 1/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.8% 1/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.8% 1/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Respiratory, thoracic and mediastinal disorders Nasal congestion	50.0% 1/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.0% 1/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.8% 1/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	50.0% 1/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	12.0% 3/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.8% 1/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	25.0% 1/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	16.7% 1/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Skin and subcutaneous tissue disorders Rash	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.3% 1/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	8.0% 2/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.8% 1/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	25.0% 1/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Surgical and medical procedures Ileostomy	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Vascular disorders Flushing	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	16.7% 1/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	5.3% 1/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	4.8% 1/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Vascular disorders Hot flush	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/3 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/2 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/4 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	16.7% 1/6 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/23 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/25 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/19 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.	0.00% 0/21 • Baseline up to 28 days after last study drug administration. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER