Trial Outcomes & Findings for Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (Vocacapsaicin) (NCT NCT04203537)

NCT ID: NCT04203537

Last Updated: 2024-05-08

Results Overview

Mean area under the curve (AUC) of the Numeric Rating Scale (NRS) weighted sum of pain intensity scores (at rest) from 0-10 where 0 is no pain and 10 is the worst pain imaginable for CA-008 compared to placebo. AUC is calculated using the standard trapezoidal rule from serial measures of NRS taken every 4 hours from 0-96 hours following surgery and twice daily from 96h to Day 15

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 193 participants
• Primary outcome timeframe: 0 to Day 15 post dose
• Results posted on: 2024-05-08

Participant Flow

Part A consisted of 3 small, sequential, placebo-controlled, dose-escalation cohorts evaluating 36, 60 and 90 mg for safety. Part B evaluated 36 and 60 mg compared to placebo in parallel, randomized groups. Efficacy data from Part A remained blinded until the end of Part B and these data were pooled for analysis.

Of the 193 enrolled participants, 193 met inclusion criteria and were randomized to treatment. 1 patient randomized to the 36 mg cohort and 1 patient randomized to the 60 mg cohort received placebo. These two patients were included in the placebo group. The efficacy and safety data from Parts A and B of the study are pooled by treatment group for the placebo, 30 mg and 60 mg treatment groups.

Participant milestones

Measure	CA-008 36 mg (Patients From Part A) Single administration CA-008 (vocacapsaicin): Local administration during surgery	CA-008 60 mg (Patients From Part A) Single administration CA-008 (vocacapsaicin): Local administration during surgery	CA-008 90 mg (Patients From Part A) Single administration CA-008 (vocacapsaicin): Local administration during surgery	Placebo (Patients From Part A) Single administration Placebo: Local administration during surgery	CA-008 36 mg (Patients From Part B) Single administration CA-008 (vocacapsaicin): Local administration during surgery	CA-008 60 mg (Patients From Part B) Single administration CA-008 (vocacapsaicin): Local administration during surgery	Placebo (Patients From Part B) Single administration Placebo: Local administration during surgery
Overall Study STARTED	6	6	6	6	54	55	60
Overall Study COMPLETED	6	6	6	6	54	55	60
Overall Study NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (Vocacapsaicin)

Baseline characteristics by cohort

Measure	CA-008 36 mg n=60 Participants Single administration CA-008: Local administration during surgery	CA-008 60 mg n=61 Participants Single administration CA-008: Local administration during surgery	CA-008 90 mg n=6 Participants Single administration CA-008: Local administration during surgery	Placebo n=66 Participants Single administration Placebo: Local administration during surgery	Total n=193 Participants Total of all reporting groups
Age, Continuous	63.9 years STANDARD_DEVIATION 7.79 • n=5 Participants	63.1 years STANDARD_DEVIATION 7.82 • n=7 Participants	65.5 years STANDARD_DEVIATION 8.92 • n=5 Participants	59.7 years STANDARD_DEVIATION 6.45 • n=4 Participants	62.3 years STANDARD_DEVIATION 7.59 • n=21 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	32 Participants n=7 Participants	4 Participants n=5 Participants	39 Participants n=4 Participants	104 Participants n=21 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	29 Participants n=7 Participants	2 Participants n=5 Participants	27 Participants n=4 Participants	89 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	16 Participants n=7 Participants	0 Participants n=5 Participants	12 Participants n=4 Participants	39 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=5 Participants	45 Participants n=7 Participants	5 Participants n=5 Participants	54 Participants n=4 Participants	153 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 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
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	10 Participants n=7 Participants	0 Participants n=5 Participants	9 Participants n=4 Participants	32 Participants n=21 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants	45 Participants n=7 Participants	5 Participants n=5 Participants	56 Participants n=4 Participants	151 Participants n=21 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
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

PRIMARY outcome

Timeframe: 0 to Day 15 post dose

Population: 193 patients - Modified Intent-to-Treat One patient who was randomized to CA-008 36 mg, but actually received Placebo is included in CA-008 36 mg. One patient who was randomized to CA-008 60 mg, but actually received Placebo is included in CA-008 60 mg.

Mean area under the curve (AUC) of the Numeric Rating Scale (NRS) weighted sum of pain intensity scores (at rest) from 0-10 where 0 is no pain and 10 is the worst pain imaginable for CA-008 compared to placebo. AUC is calculated using the standard trapezoidal rule from serial measures of NRS taken every 4 hours from 0-96 hours following surgery and twice daily from 96h to Day 15

Outcome measures

Measure	CA-008 36 mg (0.3 mg/mL Concentration) n=61 Participants Single administration CA-008: Local administration during surgery	CA-008 60 mg (0.5 mg/mL Concentration) n=62 Participants Single administration CA-008: Local administration during surgery	CA-008 90 mg (0.75 mg/mL Concentration) n=6 Participants Single administration CA-008: Local administration during surgery	Placebo n=64 Participants Single administration Placebo: Local administration during surgery
Pain Intensity Scores AUC 12-96 hour	367.41 scores on a scale*hours Standard Deviation 137.561	415.27 scores on a scale*hours Standard Deviation 140.967	373.92 scores on a scale*hours Standard Deviation 175.834	447.05 scores on a scale*hours Standard Deviation 108.596
Pain Intensity Scores AUC 0-96 hour	397.68 scores on a scale*hours Standard Deviation 152.002	448.02 scores on a scale*hours Standard Deviation 155.948	403.08 scores on a scale*hours Standard Deviation 172.515	481.97 scores on a scale*hours Standard Deviation 120.535
Pain Intensity Scores AUC 0-Day 15	1235.36 scores on a scale*hours Standard Deviation 608.259	1530.93 scores on a scale*hours Standard Deviation 571.337	1629.97 scores on a scale*hours Standard Deviation 437.951	1452.08 scores on a scale*hours Standard Deviation 493.622

SECONDARY outcome

Timeframe: 0 to Day 15 post dose

Population: 193 patients - Modified Intent-to-Treat One patient who was randomized to CA-008 36 mg, but actually received Placebo is included in CA-008 36 mg. One patient who was randomized to CA-008 60 mg, but actually received Placebo is included in CA-008 60 mg. Opioid consumption (OC) in oral morphine equivalent dose (OME)

CA-008 versus placebo comparison, total opioid consumption in oral morphine equivalents

Outcome measures

Measure	CA-008 36 mg (0.3 mg/mL Concentration) n=61 Participants Single administration CA-008: Local administration during surgery	CA-008 60 mg (0.5 mg/mL Concentration) n=62 Participants Single administration CA-008: Local administration during surgery	CA-008 90 mg (0.75 mg/mL Concentration) n=6 Participants Single administration CA-008: Local administration during surgery	Placebo n=64 Participants Single administration Placebo: Local administration during surgery
Total Opioid Consumption OC12-96 hours	141.37 mg morphine equivalents Standard Deviation 75.98	165.92 mg morphine equivalents Standard Deviation 81.48	151.04 mg morphine equivalents Standard Deviation 70.59	206.26 mg morphine equivalents Standard Deviation 82.11
Total Opioid Consumption OC0-96 hours	154.795 mg morphine equivalents Standard Deviation 85.95	183.74 mg morphine equivalents Standard Deviation 89.74	177.29 mg morphine equivalents Standard Deviation 66.67	219.94 mg morphine equivalents Standard Deviation 88.19
Total Opioid Consumption OC 0- Day 15	206.04 mg morphine equivalents Standard Deviation 132.99	275.07 mg morphine equivalents Standard Deviation 155.14	263.54 mg morphine equivalents Standard Deviation 138.11	319.12 mg morphine equivalents Standard Deviation 164.62

Adverse Events

CA-008 36 mg

Serious events: 2 serious events

Other events: 54 other events

Deaths: 0 deaths

CA-008 60 mg

Serious events: 1 serious events

Other events: 58 other events

Deaths: 0 deaths

CA-008 90 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 66 other events

Deaths: 0 deaths

Serious adverse events

Measure	CA-008 36 mg n=60 participants at risk Single administration CA-008: Local administration during surgery	CA-008 60 mg n=61 participants at risk Single administration CA-008: Local administration during surgery	CA-008 90 mg n=6 participants at risk Single administration CA-008: Local administration during surgery	Placebo n=66 participants at risk Single administration Placebo: Local administration during surgery
Cardiac disorders Myocardial Infarction	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Immune system disorders Drug hypersensitivity	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Pulmonary embolism	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.

Other adverse events

Measure	CA-008 36 mg n=60 participants at risk Single administration CA-008: Local administration during surgery	CA-008 60 mg n=61 participants at risk Single administration CA-008: Local administration during surgery	CA-008 90 mg n=6 participants at risk Single administration CA-008: Local administration during surgery	Placebo n=66 participants at risk Single administration Placebo: Local administration during surgery
Nervous system disorders Sinus headache	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Cardiac disorders Bradycardia	5.0% 3/60 • Number of events 3 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	6.6% 4/61 • Number of events 4 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	7.6% 5/66 • Number of events 5 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Cardiac disorders Tachycardia	21.7% 13/60 • Number of events 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.	27.9% 17/61 • Number of events 17 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	50.0% 3/6 • Number of events 3 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 12/66 • Number of events 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.
Gastrointestinal disorders Constipation	48.3% 29/60 • Number of events 29 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	52.5% 32/61 • Number of events 32 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	66.7% 4/6 • Number of events 4 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	45.5% 30/66 • Number of events 30 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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	40.0% 24/60 • Number of events 24 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	45.9% 28/61 • Number of events 28 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	83.3% 5/6 • Number of events 5 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 36/66 • Number of events 36 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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	15.0% 9/60 • Number of events 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.	18.0% 11/61 • Number of events 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.	16.7% 1/6 • 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.	22.7% 15/66 • Number of events 15 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Drug ineffective	5.0% 3/60 • Number of events 3 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	4.9% 3/61 • Number of events 3 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 1/6 • 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.	10.6% 7/66 • Number of events 7 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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	20.0% 12/60 • Number of events 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.	16.4% 10/61 • Number of events 10 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 2/6 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	6.1% 4/66 • Number of events 4 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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	8.3% 5/60 • Number of events 5 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	8.2% 5/61 • Number of events 5 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 1/6 • 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.	7.6% 5/66 • Number of events 5 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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	13.3% 8/60 • Number of events 8 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	3.3% 2/61 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 2/6 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	10.6% 7/66 • Number of events 7 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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	8.3% 5/60 • Number of events 5 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	11.5% 7/61 • Number of events 7 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	7.6% 5/66 • Number of events 5 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Hypoxia	5.0% 3/60 • Number of events 3 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	6.6% 4/61 • Number of events 4 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 1/6 • 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.	6.1% 4/66 • Number of events 4 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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	13.3% 8/60 • Number of events 8 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	14.8% 9/61 • Number of events 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% 2/6 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	15.2% 10/66 • Number of events 10 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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	5.0% 3/60 • Number of events 3 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	8.2% 5/61 • Number of events 5 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	6.1% 4/66 • Number of events 4 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Cardiac disorders Atrial fibrillation	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Cardiac disorders Myocardial infarction	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Cardiac disorders Supraventricular tachycardia	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Ear and labyrinth disorders Ear pain	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Eye disorders Eye irritation	1.7% 1/60 • 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.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Gastrointestinal disorders Abdominal pain	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Diarrhoea	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Flatulence	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Lip swelling	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Chills	1.7% 1/60 • 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.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Infusion site pruritus	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
General disorders Injection site bruising	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Injection site pain	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Injection site swelling	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Non-cardiac chest pain	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
General disorders Peripheral swelling	8.3% 5/60 • Number of events 5 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Immune system disorders Drug hypersensitivity	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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.	16.7% 1/6 • 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Cellulitis	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Injection site infection	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Infections and infestations Pharyngitis	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Postoperative wound infection	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Sinusitis	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Infections and infestations Urinary tract infection	1.7% 1/60 • 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.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 discharge	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Injury, poisoning and procedural complications Incision site haemorrhage	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 pain	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Injury, poisoning and procedural complications Incision site vesicles	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	3.3% 2/61 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	3.0% 2/66 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 fever	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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	1.7% 1/60 • 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.	3.3% 2/61 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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	3.3% 2/60 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	4.5% 3/66 • Number of events 3 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Alanine aminotransferase increased	3.3% 2/60 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Aspartate aminotransferase increased	3.3% 2/60 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Blood alkaline phosphatase increased	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Blood pressure decreased	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	4.5% 3/66 • Number of events 3 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Blood pressure increased	3.3% 2/60 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	4.9% 3/61 • Number of events 3 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	6.1% 4/66 • Number of events 4 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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	1.7% 1/60 • 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.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Investigations Gamma-glutamyltransferase increased	3.3% 2/60 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Haemoglobin decreased	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Gout	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	3.3% 2/61 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Metabolism and nutrition disorders Hypokalaemia	6.7% 4/60 • Number of events 4 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	3.0% 2/66 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypophosphataemia	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	4.5% 3/66 • Number of events 3 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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	1.7% 1/60 • 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.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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	1.7% 1/60 • 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.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Intervertebral disc protrusion	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Joint stiffness	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Muscle spasms	1.7% 1/60 • 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.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Musculoskeletal stiffness	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Myalgia	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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 Hypoaesthesia	1.7% 1/60 • 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.	3.3% 2/61 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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 Tremor	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	3.3% 2/61 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Insomnia	3.3% 2/60 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	3.3% 2/61 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Renal and urinary disorders Acute kidney injury	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Dysuria	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Renal failure	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Renal and urinary disorders Urinary incontinence	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Reproductive system and breast disorders Scrotal swelling	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Respiratory, thoracic and mediastinal disorders Bradypnoea	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Cough	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Oropharyngeal pain	3.3% 2/60 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	4.9% 3/61 • Number of events 3 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Pulmonary embolism	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Skin and subcutaneous tissue disorders Blister	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Skin and subcutaneous tissue disorders Ecchymosis	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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	1.7% 1/60 • 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	3.3% 2/61 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	4.5% 3/66 • Number of events 3 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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 Skin induration	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Vascular disorders Diastolic hypotension	3.3% 2/60 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Vascular disorders Haematoma	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	3.3% 2/61 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Vascular disorders Hypotension	3.3% 2/60 • Number of events 2 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/61 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.5% 1/66 • 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.
Blood and lymphatic system disorders Anaemia	0.00% 0/60 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	1.6% 1/61 • 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% 0/6 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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% 0/66 • Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29. The definition of 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