Trial Outcomes & Findings for Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia Following Total Knee Arthroplasty (NCT NCT01683071)

Last Updated: 2020-12-09

Results Overview

AUC of NRS-R pain intensity scores through 72 hours. Pain intensity scores were measured on an 11-point NRS (0=no pain and 10=worst possible pain)

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

297 participants

Primary outcome timeframe

0-72 hours

Results posted on

2020-12-09

Participant Flow

Participants were recruited between September 24, 2012 and December 20, 2013 at 23 sites in the US

An unblinded dose selection committee reviewed Part 1 results for the primary endpoint, total postsurgical opioid consumption, time to first opioid rescue, and safety data, and recommended a dose level and sample size for Part 2.

Participant milestones

Participant milestones
Measure	(Part 1) EXPAREL 67 mg 5 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 15 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively	(Part 1) EXPAREL 133 mg 10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively	(Part 1) EXPAREL 266 mg 20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively	(Part 1) Placebo 20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively	(Part 2) EXPAREL 266 mg 20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively	(Part 2) Placebo 20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
Part 1 STARTED	25	26	25	25	0	0
Part 1 COMPLETED	21	22	22	20	0	0
Part 1 NOT COMPLETED	4	4	3	5	0	0
Part 2 STARTED	0	0	0	0	99	97
Part 2 COMPLETED	0	0	0	0	82	82
Part 2 NOT COMPLETED	0	0	0	0	17	15

Reasons for withdrawal

Reasons for withdrawal
Measure	(Part 1) EXPAREL 67 mg 5 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 15 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively	(Part 1) EXPAREL 133 mg 10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively	(Part 1) EXPAREL 266 mg 20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively	(Part 1) Placebo 20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively	(Part 2) EXPAREL 266 mg 20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively	(Part 2) Placebo 20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
Part 1 Lack of Efficacy	1	0	0	3	0	0
Part 1 Withdrawal by Subject	1	2	2	1	0	0
Part 1 Surgery Cancelled	1	0	0	0	0	0
Part 1 Did not receive study drug	1	0	0	1	0	0
Part 1 Early termination; met exclusion criteria	0	2	1	0	0	0
Part 2 Lack of Efficacy	0	0	0	0	3	4
Part 2 Lost to Follow-up	0	0	0	0	2	0
Part 2 Withdrawal by Subject	0	0	0	0	3	3
Part 2 Surgery cancelled	0	0	0	0	4	2
Part 2 Did not receive study drug	0	0	0	0	2	1
Part 2 Met exclusion criterion	0	0	0	0	1	1
Part 2 Protocol deviation	0	0	0	0	1	2
Part 2 Withdrawal by investigator decision	0	0	0	0	1	2

Baseline Characteristics

One participant in the Part 2 placebo group did not have type of anesthesia recorded and therefore was not included in this analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	(Part 1) EXPAREL 67 mg n=22 Participants 5 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 15 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively	(Part 1) EXPAREL 133 mg n=24 Participants 10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively	(Part 1) EXPAREL 266 mg n=24 Participants 20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively	(Part 1) Placebo n=24 Participants 20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively	(Part 2) EXPAREL 266 mg n=92 Participants 20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively	(Part 2) Placebo n=92 Participants 20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively	Total n=278 Participants Total of all reporting groups
Age, Continuous	68.5 years STANDARD_DEVIATION 8.41 • n=22 Participants	65.7 years STANDARD_DEVIATION 7.30 • n=24 Participants	66.4 years STANDARD_DEVIATION 8.94 • n=24 Participants	66.1 years STANDARD_DEVIATION 12.17 • n=24 Participants	66.4 years STANDARD_DEVIATION 10.35 • n=92 Participants	63.6 years STANDARD_DEVIATION 8.76 • n=92 Participants	65.0 years STANDARD_DEVIATION 9.67 • n=278 Participants
Sex: Female, Male Female	8 Participants n=22 Participants	16 Participants n=24 Participants	14 Participants n=24 Participants	14 Participants n=24 Participants	52 Participants n=92 Participants	57 Participants n=92 Participants	161 Participants n=278 Participants
Sex: Female, Male Male	14 Participants n=22 Participants	8 Participants n=24 Participants	10 Participants n=24 Participants	10 Participants n=24 Participants	40 Participants n=92 Participants	35 Participants n=92 Participants	117 Participants n=278 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=22 Participants	1 Participants n=24 Participants	2 Participants n=24 Participants	3 Participants n=24 Participants	8 Participants n=92 Participants	9 Participants n=92 Participants	24 Participants n=278 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=22 Participants	23 Participants n=24 Participants	22 Participants n=24 Participants	21 Participants n=24 Participants	84 Participants n=92 Participants	83 Participants n=92 Participants	254 Participants n=278 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=22 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=92 Participants	0 Participants n=92 Participants	0 Participants n=278 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=22 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=92 Participants	1 Participants n=92 Participants	1 Participants n=278 Participants
Race (NIH/OMB) Asian	1 Participants n=22 Participants	0 Participants n=24 Participants	1 Participants n=24 Participants	0 Participants n=24 Participants	2 Participants n=92 Participants	0 Participants n=92 Participants	4 Participants n=278 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=22 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=92 Participants	0 Participants n=92 Participants	0 Participants n=278 Participants
Race (NIH/OMB) Black or African American	1 Participants n=22 Participants	2 Participants n=24 Participants	2 Participants n=24 Participants	4 Participants n=24 Participants	15 Participants n=92 Participants	14 Participants n=92 Participants	38 Participants n=278 Participants
Race (NIH/OMB) White	20 Participants n=22 Participants	22 Participants n=24 Participants	21 Participants n=24 Participants	20 Participants n=24 Participants	75 Participants n=92 Participants	76 Participants n=92 Participants	234 Participants n=278 Participants
Race (NIH/OMB) More than one race	0 Participants n=22 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=92 Participants	1 Participants n=92 Participants	1 Participants n=278 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=22 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=92 Participants	0 Participants n=92 Participants	0 Participants n=278 Participants
Region of Enrollment United States	22 participants n=22 Participants	24 participants n=24 Participants	24 participants n=24 Participants	24 participants n=24 Participants	92 participants n=92 Participants	92 participants n=92 Participants	278 participants n=278 Participants
American Society of Anesthesiologists (ASA) classification 1	0 Participants n=22 Participants	0 Participants n=24 Participants	1 Participants n=24 Participants	0 Participants n=24 Participants	7 Participants n=92 Participants	3 Participants n=92 Participants	11 Participants n=278 Participants
American Society of Anesthesiologists (ASA) classification 2	11 Participants n=22 Participants	16 Participants n=24 Participants	13 Participants n=24 Participants	15 Participants n=24 Participants	38 Participants n=92 Participants	49 Participants n=92 Participants	142 Participants n=278 Participants
American Society of Anesthesiologists (ASA) classification 3	11 Participants n=22 Participants	8 Participants n=24 Participants	10 Participants n=24 Participants	9 Participants n=24 Participants	47 Participants n=92 Participants	40 Participants n=92 Participants	125 Participants n=278 Participants
American Society of Anesthesiologists (ASA) classification >/= 4	0 Participants n=22 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=92 Participants	0 Participants n=92 Participants	0 Participants n=278 Participants
Type of Anesthesia General	15 Participants n=22 Participants • One participant in the Part 2 placebo group did not have type of anesthesia recorded and therefore was not included in this analysis.	17 Participants n=24 Participants • One participant in the Part 2 placebo group did not have type of anesthesia recorded and therefore was not included in this analysis.	12 Participants n=24 Participants • One participant in the Part 2 placebo group did not have type of anesthesia recorded and therefore was not included in this analysis.	21 Participants n=24 Participants • One participant in the Part 2 placebo group did not have type of anesthesia recorded and therefore was not included in this analysis.	62 Participants n=92 Participants • One participant in the Part 2 placebo group did not have type of anesthesia recorded and therefore was not included in this analysis.	56 Participants n=91 Participants • One participant in the Part 2 placebo group did not have type of anesthesia recorded and therefore was not included in this analysis.	183 Participants n=277 Participants • One participant in the Part 2 placebo group did not have type of anesthesia recorded and therefore was not included in this analysis.
Type of Anesthesia Spinal	6 Participants n=22 Participants • One participant in the Part 2 placebo group did not have type of anesthesia recorded and therefore was not included in this analysis.	7 Participants n=24 Participants • One participant in the Part 2 placebo group did not have type of anesthesia recorded and therefore was not included in this analysis.	12 Participants n=24 Participants • One participant in the Part 2 placebo group did not have type of anesthesia recorded and therefore was not included in this analysis.	3 Participants n=24 Participants • One participant in the Part 2 placebo group did not have type of anesthesia recorded and therefore was not included in this analysis.	28 Participants n=92 Participants • One participant in the Part 2 placebo group did not have type of anesthesia recorded and therefore was not included in this analysis.	35 Participants n=91 Participants • One participant in the Part 2 placebo group did not have type of anesthesia recorded and therefore was not included in this analysis.	91 Participants n=277 Participants • One participant in the Part 2 placebo group did not have type of anesthesia recorded and therefore was not included in this analysis.
Type of Anesthesia Other	1 Participants n=22 Participants • One participant in the Part 2 placebo group did not have type of anesthesia recorded and therefore was not included in this analysis.	0 Participants n=24 Participants • One participant in the Part 2 placebo group did not have type of anesthesia recorded and therefore was not included in this analysis.	0 Participants n=24 Participants • One participant in the Part 2 placebo group did not have type of anesthesia recorded and therefore was not included in this analysis.	0 Participants n=24 Participants • One participant in the Part 2 placebo group did not have type of anesthesia recorded and therefore was not included in this analysis.	2 Participants n=92 Participants • One participant in the Part 2 placebo group did not have type of anesthesia recorded and therefore was not included in this analysis.	0 Participants n=91 Participants • One participant in the Part 2 placebo group did not have type of anesthesia recorded and therefore was not included in this analysis.	3 Participants n=277 Participants • One participant in the Part 2 placebo group did not have type of anesthesia recorded and therefore was not included in this analysis.
Duration of Surgery	85.8 minutes STANDARD_DEVIATION 25.53 • n=22 Participants • One participant in the Part 2 placebo group did not have duration of surgery recorded and therefore was not included in this analysis.	88.5 minutes STANDARD_DEVIATION 27.96 • n=24 Participants • One participant in the Part 2 placebo group did not have duration of surgery recorded and therefore was not included in this analysis.	96.0 minutes STANDARD_DEVIATION 37.94 • n=24 Participants • One participant in the Part 2 placebo group did not have duration of surgery recorded and therefore was not included in this analysis.	85.0 minutes STANDARD_DEVIATION 35.53 • n=24 Participants • One participant in the Part 2 placebo group did not have duration of surgery recorded and therefore was not included in this analysis.	94.1 minutes STANDARD_DEVIATION 34.43 • n=92 Participants • One participant in the Part 2 placebo group did not have duration of surgery recorded and therefore was not included in this analysis.	94.9 minutes STANDARD_DEVIATION 37.54 • n=91 Participants • One participant in the Part 2 placebo group did not have duration of surgery recorded and therefore was not included in this analysis.	94.5 minutes STANDARD_DEVIATION 35.9 • n=277 Participants • One participant in the Part 2 placebo group did not have duration of surgery recorded and therefore was not included in this analysis.
Incision length	16.51 cm STANDARD_DEVIATION 2.457 • n=22 Participants • One participant in the Part 1 EXPAREL 266 mg group, one participant in the Part 2 EXPAREL 266 mg group, and three participants in the Part 2 placebo group did not have incision length recorded and therefore were not included in this analysis.	14.98 cm STANDARD_DEVIATION 3.650 • n=24 Participants • One participant in the Part 1 EXPAREL 266 mg group, one participant in the Part 2 EXPAREL 266 mg group, and three participants in the Part 2 placebo group did not have incision length recorded and therefore were not included in this analysis.	15.23 cm STANDARD_DEVIATION 2.834 • n=23 Participants • One participant in the Part 1 EXPAREL 266 mg group, one participant in the Part 2 EXPAREL 266 mg group, and three participants in the Part 2 placebo group did not have incision length recorded and therefore were not included in this analysis.	18.25 cm STANDARD_DEVIATION 3.870 • n=24 Participants • One participant in the Part 1 EXPAREL 266 mg group, one participant in the Part 2 EXPAREL 266 mg group, and three participants in the Part 2 placebo group did not have incision length recorded and therefore were not included in this analysis.	16.92 cm STANDARD_DEVIATION 4.987 • n=91 Participants • One participant in the Part 1 EXPAREL 266 mg group, one participant in the Part 2 EXPAREL 266 mg group, and three participants in the Part 2 placebo group did not have incision length recorded and therefore were not included in this analysis.	16.29 cm STANDARD_DEVIATION 5.189 • n=89 Participants • One participant in the Part 1 EXPAREL 266 mg group, one participant in the Part 2 EXPAREL 266 mg group, and three participants in the Part 2 placebo group did not have incision length recorded and therefore were not included in this analysis.	16.6 cm STANDARD_DEVIATION 5.08 • n=273 Participants • One participant in the Part 1 EXPAREL 266 mg group, one participant in the Part 2 EXPAREL 266 mg group, and three participants in the Part 2 placebo group did not have incision length recorded and therefore were not included in this analysis.

PRIMARY outcome

Timeframe: 0-72 hours

Population: Efficacy population: all participants in the safety analysis set who underwent the planned surgery, with analysis based on randomized treatment (regardless of treatment received)

AUC of NRS-R pain intensity scores through 72 hours. Pain intensity scores were measured on an 11-point NRS (0=no pain and 10=worst possible pain)

Outcome measures

Outcome measures
Measure	(Part 1) EXPAREL 67 mg n=22 Participants 5 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 15 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively EXPAREL: EXPAREL 67 mg, 133 mg, or 266 mg	(Part 1) EXPAREL 133 mg n=24 Participants 10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively EXPAREL: EXPAREL 67 mg, 133 mg, or 266 mg	(Part 1) EXPAREL 266 mg n=24 Participants 20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively EXPAREL: EXPAREL 67 mg, 133 mg, or 266 mg	(Part 1) Placebo n=24 Participants 20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively Placebo: Normal saline 20 mL	(Part 2) EXPAREL 266 mg n=92 Participants 20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively EXPAREL: EXPAREL 67 mg, 133 mg, or 266 mg	(Part 2) Placebo n=91 Participants 20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively Placebo: Normal saline 20 mL
Area Under the Curve (AUC) of Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours	533.4 score on a scale * hr Standard Deviation 33.15	427.2 score on a scale * hr Standard Deviation 31.73	436.2 score on a scale * hr Standard Deviation 31.79	530.5 score on a scale * hr Standard Deviation 31.73	418.9 score on a scale * hr Standard Deviation 16.86	515.5 score on a scale * hr Standard Deviation 16.95

SECONDARY outcome

Timeframe: 0-72 hours

Population: Efficacy population: all participants in the safety analysis set who underwent the planned surgery, with analysis based on randomized treatment (regardless of treatment received)

Total postsurgical opioid consumption of opioid rescue pain medication (converted to IV morphine equivalents) through 72 hours

Outcome measures

Outcome measures
Measure	(Part 1) EXPAREL 67 mg n=22 Participants 5 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 15 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively EXPAREL: EXPAREL 67 mg, 133 mg, or 266 mg	(Part 1) EXPAREL 133 mg n=24 Participants 10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively EXPAREL: EXPAREL 67 mg, 133 mg, or 266 mg	(Part 1) EXPAREL 266 mg n=24 Participants 20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively EXPAREL: EXPAREL 67 mg, 133 mg, or 266 mg	(Part 1) Placebo n=24 Participants 20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively Placebo: Normal saline 20 mL	(Part 2) EXPAREL 266 mg n=92 Participants 20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively EXPAREL: EXPAREL 67 mg, 133 mg, or 266 mg	(Part 2) Placebo n=91 Participants 20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively Placebo: Normal saline 20 mL
Total Postsurgical Opioid Consumption Through 72 Hours	126.69 mg morphine equivalents Standard Deviation 75.972	100.35 mg morphine equivalents Standard Deviation 53.177	105.96 mg morphine equivalents Standard Deviation 53.402	124.78 mg morphine equivalents Standard Deviation 58.743	93.19 mg morphine equivalents Standard Deviation 58.133	122.08 mg morphine equivalents Standard Deviation 70.312

SECONDARY outcome

Timeframe: 0-72 hours

Population: Efficacy population: all participants in the safety analysis set who underwent the planned surgery, with analysis based on randomized treatment (regardless of treatment received)

Time to first opioid rescue medication consumed through 72 hours

Outcome measures

Outcome measures
Measure	(Part 1) EXPAREL 67 mg n=22 Participants 5 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 15 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively EXPAREL: EXPAREL 67 mg, 133 mg, or 266 mg	(Part 1) EXPAREL 133 mg n=24 Participants 10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively EXPAREL: EXPAREL 67 mg, 133 mg, or 266 mg	(Part 1) EXPAREL 266 mg n=24 Participants 20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively EXPAREL: EXPAREL 67 mg, 133 mg, or 266 mg	(Part 1) Placebo n=24 Participants 20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively Placebo: Normal saline 20 mL	(Part 2) EXPAREL 266 mg n=92 Participants 20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively EXPAREL: EXPAREL 67 mg, 133 mg, or 266 mg	(Part 2) Placebo n=91 Participants 20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively Placebo: Normal saline 20 mL
Time to First Opioid Rescue Through 72 Hours	0.49 hours Interval 0.3 to 0.65	0.37 hours Interval 0.283 to 0.7	1.29 hours Interval 0.367 to 2.35	0.41 hours Interval 0.3 to 0.55	0.44 hours Interval 0.4 to 0.533	0.43 hours Interval 0.367 to 0.567

Adverse Events

(Part 1) EXPAREL 67 mg

Serious events: 4 serious events

Other events: 19 other events

Deaths: 0 deaths

(Part 1) EXPAREL 133 mg

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

(Part 1) EXPAREL 266 mg

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

(Part 1) Placebo

Serious events: 3 serious events

Other events: 21 other events

Deaths: 0 deaths

(Part 2) EXPAREL 266 mg

Serious events: 8 serious events

Other events: 82 other events

Deaths: 0 deaths

(Part 2) Placebo

Serious events: 9 serious events

Other events: 83 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	(Part 1) EXPAREL 67 mg n=22 participants at risk 5 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 15 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively	(Part 1) EXPAREL 133 mg n=24 participants at risk 10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively	(Part 1) EXPAREL 266 mg n=24 participants at risk 20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively	(Part 1) Placebo n=24 participants at risk 20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively	(Part 2) EXPAREL 266 mg n=92 participants at risk 20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively	(Part 2) Placebo n=92 participants at risk 20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
Blood and lymphatic system disorders Anemia	9.1% 2/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.2% 1/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	1.1% 1/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	2.2% 2/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Infections and infestations Cellulitis	4.5% 1/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Infections and infestations Device Related Infection	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.2% 1/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Infections and infestations Wound Infection	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.2% 1/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	1.1% 1/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Injury, poisoning and procedural complications Wound Dehiscence	4.5% 1/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.2% 1/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Injury, poisoning and procedural complications Wound Decomposition	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.2% 1/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Injury, poisoning and procedural complications Wound Necrosis	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.2% 1/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
General disorders Local Swelling	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.2% 1/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Investigations Liver function test abnormal	4.5% 1/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Nervous system disorders Syncope	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.2% 1/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	1.1% 1/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Renal and urinary disorders Acute Prerenal Failure	4.5% 1/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.2% 1/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Vascular disorders Deep Vein Thrombosis	4.5% 1/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Infections and infestations Pneumonia	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	1.1% 1/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	1.1% 1/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Infections and infestations Urinary Tract Infection	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	2.2% 2/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
General disorders Pyrexia	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.3% 4/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	1.1% 1/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
General disorders Edema	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	1.1% 1/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
General disorders Systemic Inflammatory Response Syndrome	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	1.1% 1/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Gastrointestinal disorders ileus	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	1.1% 1/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	1.1% 1/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	1.1% 1/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Metabolism and nutrition disorders Hypovolemia	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	1.1% 1/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Vascular disorders Orthostatic Hypotension	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	1.1% 1/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	1.1% 1/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Cardiac disorders Cardiac Failure Congestive	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	1.1% 1/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Cardiac disorders Myocardial Infarction	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	1.1% 1/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Immune system disorders Type IV Hypersensitivity Reaction	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	1.1% 1/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary Congestion	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	1.1% 1/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.

Other adverse events

Other adverse events
Measure	(Part 1) EXPAREL 67 mg n=22 participants at risk 5 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 15 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively	(Part 1) EXPAREL 133 mg n=24 participants at risk 10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively	(Part 1) EXPAREL 266 mg n=24 participants at risk 20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively	(Part 1) Placebo n=24 participants at risk 20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively	(Part 2) EXPAREL 266 mg n=92 participants at risk 20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively	(Part 2) Placebo n=92 participants at risk 20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
Gastrointestinal disorders Nausea	36.4% 8/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	58.3% 14/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	54.2% 13/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	37.5% 9/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	53.3% 49/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	66.3% 61/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Gastrointestinal disorders Constipation	13.6% 3/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	8.3% 2/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	25.0% 6/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.2% 1/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	34.8% 32/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	34.8% 32/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Gastrointestinal disorders Vomiting	4.5% 1/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.2% 1/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	8.3% 2/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	28.3% 26/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	41.3% 38/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
General disorders Pyrexia	36.4% 8/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	29.2% 7/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	33.3% 8/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	12.5% 3/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	30.4% 28/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	26.1% 24/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Nervous system disorders Dizziness	13.6% 3/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	12.5% 3/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	16.7% 4/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	25.0% 6/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	16.3% 15/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	20.7% 19/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Nervous system disorders Headache	4.5% 1/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	12.5% 3/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	8.3% 2/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.2% 1/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	5.4% 5/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.3% 4/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Nervous system disorders Tremor	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	8.3% 2/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Blood and lymphatic system disorders Anaemia	18.2% 4/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.2% 1/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	16.7% 4/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	8.3% 2/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	8.7% 8/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	5.4% 5/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Psychiatric disorders Insomnia	4.5% 1/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	8.3% 2/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	8.3% 2/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	16.7% 4/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	5.4% 5/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	12.0% 11/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Psychiatric disorders Confusional State	4.5% 1/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	8.3% 2/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	3.3% 3/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	3.3% 3/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Skin and subcutaneous tissue disorders Pruritis	4.5% 1/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	8.3% 2/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	8.3% 2/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	8.3% 2/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	35.9% 33/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	33.7% 31/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Skin and subcutaneous tissue disorders Pruritis Generalized	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.2% 1/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	12.5% 3/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	2.2% 2/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	2.2% 2/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Injury, poisoning and procedural complications Procedural Hypotension	9.1% 2/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	8.3% 2/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	12.5% 3/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	10.9% 10/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	6.5% 6/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Injury, poisoning and procedural complications Wound Dehiscence	9.1% 2/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.2% 1/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	2.2% 2/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Vascular disorders Hypertension	4.5% 1/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	8.3% 2/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	3.3% 3/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	6.5% 6/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Vascular disorders Hypotension	4.5% 1/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	8.3% 2/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	3.3% 3/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	8.7% 8/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Infections and infestations Cellulitis	9.1% 2/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	1.1% 1/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Investigations Body Temperature Increased	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	8.3% 2/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	6.5% 6/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.3% 4/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
General disorders Feeling Cold	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.2% 1/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	9.8% 9/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	8.7% 8/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
General disorders Local Swelling	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.2% 1/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	6.5% 6/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	5.4% 5/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.2% 1/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.2% 1/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	10.9% 10/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	12.0% 11/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Injury, poisoning and procedural complications Anemia Postoperative	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	4.2% 1/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	6.5% 6/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	9.8% 9/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Renal and urinary disorders Urinary Retention	4.5% 1/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	13.0% 12/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	6.5% 6/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Cardiac disorders Tachycardia	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	5.4% 5/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	6.5% 6/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.
Musculoskeletal and connective tissue disorders Mobility Decreased	0.00% 0/22 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	0.00% 0/24 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	6.5% 6/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.	5.4% 5/92 • From screening through postsurgical day 30 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set includes all subjects who received study drug, based on treatment received.

Additional Information

Pacira Medical Information

Pacira Pharmaceuticals, Inc.

Phone: 1-855-793-9727

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Results conducted at Site shall not be published before 1st multicenter publication by Sponsor but can proceed if there is no such publication ≤18 months after study completion/termination at all sites and all data have been received. Before submitting manuscript/materials to an outside person/entity, site shall give Sponsor 60 days to review and comment. Site shall, upon request, further delay publication/presentation for ≤120 days to allow Sponsor to protect its interests in Inventions.
Publication restrictions are in place

Restriction type: OTHER