Trial Outcomes & Findings for Study of CA-008 (Vocacapsaicin) in Total Knee Arthroplasty (NCT NCT03731364)

NCT ID: NCT03731364

Last Updated: 2022-02-15

Results Overview

Primary Efficacy Endpoint for the Pilot Stage. Time-specific mean pain intensity scores at Time 96 hours for CA-008 vs. placebo based on a 10-point numerical rating scale (NRS) from 0-10 where 0 is no pain and 10 is the worst pain imaginable).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 55 participants
• Primary outcome timeframe: At 96 hours
• Results posted on: 2022-02-15

Participant Flow

One subject in Cohort 3, CA-008 15 mg had an adverse event before receiving treatment and was discontinued from the study without receiving study drug. This subject is not included in the results section

Participant milestones

Measure	CA-008 5 mg (0.05 mg/mL) Cohort 1 Cohort 1 (5 mg), was prepared at 0.05 mg/mL CA-008	Placebo - Cohort 1 Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active	CA-008 10 mg (0.1 mg/mL) Cohort 2 Cohort 2 (10 mg), was prepared at 0.1 mg/mL CA-008	CA-008 15 mg (0.15 mg/mL) Cohort 3 Cohort 3 (15 mg), was prepared at 0.15 mg/mL CA-008	Placebo - Cohorts 2 and 3 Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active
Overall Study STARTED	9	9	13	13	11
Overall Study COMPLETED	9	9	12	11	10
Overall Study NOT COMPLETED	0	0	1	2	1

Reasons for withdrawal

Measure	CA-008 5 mg (0.05 mg/mL) Cohort 1 Cohort 1 (5 mg), was prepared at 0.05 mg/mL CA-008	Placebo - Cohort 1 Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active	CA-008 10 mg (0.1 mg/mL) Cohort 2 Cohort 2 (10 mg), was prepared at 0.1 mg/mL CA-008	CA-008 15 mg (0.15 mg/mL) Cohort 3 Cohort 3 (15 mg), was prepared at 0.15 mg/mL CA-008	Placebo - Cohorts 2 and 3 Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active
Overall Study Adverse Event	0	0	1	2	1

Baseline Characteristics

Study of CA-008 (Vocacapsaicin) in Total Knee Arthroplasty

Baseline characteristics by cohort

Measure	CA-008 5 mg (0.05 mg/mL) Cohort 1 n=9 Participants Cohort 1 (5 mg), was prepared at 0.05 mg/mL CA-008	Placebo - Cohort 1 n=9 Participants Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active	CA-008 10 mg (0.1 mg/mL) Cohort 2 n=13 Participants Cohort 2 (10 mg), was prepared at 0.1 mg/mL CA-008	CA-008 15 mg (0.15 mg/mL) Cohort 3 n=12 Participants Cohort 3 (15 mg), was prepared at 0.15 mg/mL CA-008	Placebo - Cohorts 2 and 3 n=11 Participants Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active	Total n=54 Participants Total of all reporting groups
Age, Continuous	64.9 years STANDARD_DEVIATION 9.62 • n=5 Participants	61.4 years STANDARD_DEVIATION 7.67 • n=7 Participants	66.8 years STANDARD_DEVIATION 7.30 • n=5 Participants	67.0 years STANDARD_DEVIATION 8.57 • n=4 Participants	64.8 years STANDARD_DEVIATION 7.26 • n=21 Participants	65.2 years STANDARD_DEVIATION 8.00 • n=10 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	6 Participants n=4 Participants	4 Participants n=21 Participants	29 Participants n=10 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	7 Participants n=21 Participants	25 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	7 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants	10 Participants n=4 Participants	10 Participants n=21 Participants	47 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	7 Participants n=10 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	9 Participants n=21 Participants	45 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Region of Enrollment United States	9 participants n=5 Participants	9 participants n=7 Participants	13 participants n=5 Participants	12 participants n=4 Participants	11 participants n=21 Participants	54 participants n=10 Participants

PRIMARY outcome

Timeframe: At 96 hours

Population: Safety Population

Primary Efficacy Endpoint for the Pilot Stage. Time-specific mean pain intensity scores at Time 96 hours for CA-008 vs. placebo based on a 10-point numerical rating scale (NRS) from 0-10 where 0 is no pain and 10 is the worst pain imaginable).

Outcome measures

Measure	CA-008 5 mg (0.05 mg/mL) Cohort 1 n=9 Participants Cohort 1 (5 mg), was prepared at 0.05 mg/mL CA-008	Placebo - Cohort 1 n=9 Participants Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active	CA-008 10 mg (0.1 mg/mL) Cohort 2 n=13 Participants Cohort 2 (10 mg), was prepared at 0.1 mg/mL CA-008	CA-008 15 mg (0.15 mg/mL) Cohort 3 n=12 Participants Cohort 3 (15 mg), was prepared at 0.15 mg/mL CA-008	Placebo - Cohorts 2 and 3 n=11 Participants Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active
Time-specific Mean Pain Intensity Scores (NRS) at Time 96 Hours for CA-008 vs. Placebo	3.8 scores on a scale Standard Deviation 2.11	5.1 scores on a scale Standard Deviation 2.85	4.9 scores on a scale Standard Deviation 2.02	4.8 scores on a scale Standard Deviation 3.47	5.5 scores on a scale Standard Deviation 2.91

PRIMARY outcome

Timeframe: From 0 hours to 96 hours

Population: Safety Population

Primary Efficacy Endpoint for Stage 2. Area Under the Curve (AUC) of the NRS current pain intensity scores from Time 0 hours to 96 hours at rest (AUC0 to 96h) where 0 is no pain and 10 is the worst pain imaginable for CA-008 compared to placebo. •

During the inpatient stay, NRS at rest beginning with the PACU admission may be assessed once the subject is awake.

The maximum is an NRS score of 10 x all 96 hours = 960 NRS units*hrs; the minimum is 0 x 96h = 0 NRS units*hrs

Outcome measures

Measure	CA-008 5 mg (0.05 mg/mL) Cohort 1 n=9 Participants Cohort 1 (5 mg), was prepared at 0.05 mg/mL CA-008	Placebo - Cohort 1 n=9 Participants Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active	CA-008 10 mg (0.1 mg/mL) Cohort 2 n=13 Participants Cohort 2 (10 mg), was prepared at 0.1 mg/mL CA-008	CA-008 15 mg (0.15 mg/mL) Cohort 3 n=12 Participants Cohort 3 (15 mg), was prepared at 0.15 mg/mL CA-008	Placebo - Cohorts 2 and 3 n=11 Participants Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active
CA-008 Dose vs. Placebo Comparison: Area Under the Curve (AUC) 0 to 96 Hours	476.13 NRS units*hours Standard Deviation 182.315	593.93 NRS units*hours Standard Deviation 178.958	529.51 NRS units*hours Standard Deviation 147.247	532.14 NRS units*hours Standard Deviation 188.144	539.43 NRS units*hours Standard Deviation 217.047

SECONDARY outcome

Timeframe: Time 0 hours to Time 96 hours: Opioid Free 0 hours to 96 hours

Population: Safety Population

Key Secondary Efficacy Endpoints for Stage 2. For each CA-008 dose vs. placebo comparison, percentage of subjects who do not require opioids.

Outcome measures

Measure	CA-008 5 mg (0.05 mg/mL) Cohort 1 n=9 Participants Cohort 1 (5 mg), was prepared at 0.05 mg/mL CA-008	Placebo - Cohort 1 n=9 Participants Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active	CA-008 10 mg (0.1 mg/mL) Cohort 2 n=13 Participants Cohort 2 (10 mg), was prepared at 0.1 mg/mL CA-008	CA-008 15 mg (0.15 mg/mL) Cohort 3 n=12 Participants Cohort 3 (15 mg), was prepared at 0.15 mg/mL CA-008	Placebo - Cohorts 2 and 3 n=11 Participants Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active
Percentage of Subjects Who do Not Require Opioids	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: OC from Time 0 hours to Time 96 hours: OC 0 hours to 96 hours

Population: Safety Population

Key Secondary Efficacy Endpoints for Stage 2. Mean total postoperative opioid consumption (in daily oral morphine equivalents) for CA-008 compared to placebo

Outcome measures

Measure	CA-008 5 mg (0.05 mg/mL) Cohort 1 n=9 Participants Cohort 1 (5 mg), was prepared at 0.05 mg/mL CA-008	Placebo - Cohort 1 n=9 Participants Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active	CA-008 10 mg (0.1 mg/mL) Cohort 2 n=13 Participants Cohort 2 (10 mg), was prepared at 0.1 mg/mL CA-008	CA-008 15 mg (0.15 mg/mL) Cohort 3 n=12 Participants Cohort 3 (15 mg), was prepared at 0.15 mg/mL CA-008	Placebo - Cohorts 2 and 3 n=11 Participants Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active
Total Opioid Consumption (in Daily Oral Morphine Equivalents)	244.17 mg morphine equivalents Standard Deviation 170.578	321.33 mg morphine equivalents Standard Deviation 137.462	242.77 mg morphine equivalents Standard Deviation 133.667	365.25 mg morphine equivalents Standard Deviation 201.161	280.36 mg morphine equivalents Standard Deviation 174.278

Adverse Events

CA-008 5 mg (0.05 mg/mL) Cohort 1

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo - Cohort 1

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

CA-008 10 mg (0.1 mg/mL) Cohort 2

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

CA-008 15 mg (0.15 mg/mL) Cohort 3

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo - Cohorts 2 and 3

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	CA-008 5 mg (0.05 mg/mL) Cohort 1 n=9 participants at risk Cohort 1 (5 mg), was prepared at 0.05 mg/mL CA-008	Placebo - Cohort 1 n=9 participants at risk Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active	CA-008 10 mg (0.1 mg/mL) Cohort 2 n=13 participants at risk Cohort 2 (10 mg), was prepared at 0.1 mg/mL CA-008	CA-008 15 mg (0.15 mg/mL) Cohort 3 n=12 participants at risk Cohort 3 (15 mg), was prepared at 0.15 mg/mL CA-008	Placebo - Cohorts 2 and 3 n=11 participants at risk Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active
General disorders Perforated ulcer	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	9.1% 1/11 • Number of events 1 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Nervous system disorders Cerebrovascular accident	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	8.3% 1/12 • Number of events 1 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Nervous system disorders Seizure	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	8.3% 1/12 • Number of events 1 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Vascular disorders Deep vein thrombosis	11.1% 1/9 • Number of events 1 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.

Other adverse events

Measure	CA-008 5 mg (0.05 mg/mL) Cohort 1 n=9 participants at risk Cohort 1 (5 mg), was prepared at 0.05 mg/mL CA-008	Placebo - Cohort 1 n=9 participants at risk Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active	CA-008 10 mg (0.1 mg/mL) Cohort 2 n=13 participants at risk Cohort 2 (10 mg), was prepared at 0.1 mg/mL CA-008	CA-008 15 mg (0.15 mg/mL) Cohort 3 n=12 participants at risk Cohort 3 (15 mg), was prepared at 0.15 mg/mL CA-008	Placebo - Cohorts 2 and 3 n=11 participants at risk Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active
Cardiac disorders Sinus tachycardia	55.6% 5/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	15.4% 2/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	25.0% 3/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	54.5% 6/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Abdominal distension	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Constipation	22.2% 2/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	33.3% 3/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	25.0% 3/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Dyspepsia	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	15.4% 2/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Nausea	55.6% 5/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	55.6% 5/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	61.5% 8/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	41.7% 5/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	36.4% 4/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Vomiting	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	30.8% 4/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	41.7% 5/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	18.2% 2/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
General disorders Application site pain	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	22.2% 2/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
General disorders Instillation site induration	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
General disorders Oedema peripheral	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	8.3% 1/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	9.1% 1/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
General disorders Perforated ulcer	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	9.1% 1/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
General disorders Peripheral swelling	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	9.1% 1/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
General disorders Pyrexia	33.3% 3/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	22.2% 2/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	30.8% 4/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	16.7% 2/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	9.1% 1/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Infections and infestations Respiratory tract infection	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Infections and infestations Upper respiratory tract infection	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Infections and infestations Urinary tract infection	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	8.3% 1/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Injury, poisoning and procedural complications Contusion	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	16.7% 2/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Injury, poisoning and procedural complications Deep vein thrombosis postoperative	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	7.7% 1/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Injury, poisoning and procedural complications Incision site vesicles	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	9.1% 1/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	8.3% 1/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Injury, poisoning and procedural complications Post procedural haematoma	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	22.2% 2/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	9.1% 1/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Injury, poisoning and procedural complications Post procedural haemorrhage	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	9.1% 1/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Injury, poisoning and procedural complications Post procedural oedema	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	7.7% 1/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Injury, poisoning and procedural complications Postoperative wound complication	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	8.3% 1/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	8.3% 1/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	9.1% 1/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Injury, poisoning and procedural complications Wound secretion	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Investigations Electrocardiogram QT prolonged	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	8.3% 1/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	7.7% 1/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	8.3% 1/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	9.1% 1/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	9.1% 1/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders Groin pain	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	15.4% 2/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	8.3% 1/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Nervous system disorders Allodynia	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Nervous system disorders Cerebrovascular accident	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	8.3% 1/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Nervous system disorders Dizziness	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	7.7% 1/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	16.7% 2/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Nervous system disorders Dysarthria	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	8.3% 1/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Nervous system disorders Headache	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Nervous system disorders Paraesthesia	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Nervous system disorders Seizure	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	8.3% 1/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Nervous system disorders Tremor	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	7.7% 1/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Psychiatric disorders Anxiety	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	7.7% 1/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Renal and urinary disorders Pollakiuria	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Renal and urinary disorders Urinary retention	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	8.3% 1/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	7.7% 1/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Respiratory depression	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	8.3% 1/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Blister	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	8.3% 1/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	9.1% 1/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	7.7% 1/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	16.7% 2/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Rash	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	7.7% 1/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Surgical and medical procedures Post procedural drainage	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	9.1% 1/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Vascular disorders Deep vein thrombosis	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Vascular disorders Hot flush	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Vascular disorders Hypertension	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	15.4% 2/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	33.3% 4/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	18.2% 2/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Vascular disorders Hypotension	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	11.1% 1/9 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	15.4% 2/13 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	16.7% 2/12 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/11 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.

Additional Information

Nancy Wu

Concentric Analgesics

Phone: (415) 484-7921

Email: nancy@concentricanalgesics.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60