Abdominoplasty
Conditions
Keywords
pain, neurotoxin
Brief summary
To determine the safety and efficacy of single intra-operative treatment of Botulinum Neurotoxin Serotype E (EB-001) intramuscular (IM) injections into the Rectus Abdominus (RA) in participants undergoing abdominoplasty.
Interventions
BIOLOGICALBotulinum Neurotoxin Serotype E
Single botulinum neurotoxin serotype E injection into RA muscles during abdominoplasty surgery.
DRUGPlacebo
Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
23 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Men or women 23 to 55 years of age, inclusive 2. Scheduled to undergo elective abdominoplasty surgery with full length plication from xyphoid to pubis, and removal of skin/fat flap under general anesthesia (endotracheal or otherwise) without liposuction 3. American Society of Anesthesiologist (ASA) Physical Class 1-2.
Exclusion criteria
1. History of prior major abdominal surgery as judged by the investigator 2. Pre-existing lung disease that could impact participant safety in the opinion of the investigator 3. Pre-existing disorders of the neuromuscular junction (myasthenia gravis, Eaton- Lambert syndrome, or amyotrophic lateral Sclerosis) 4. At high risk of deep vein thrombosis as judged by the investigators determined by a Caprini score of 3 or higher 5. Slow vital capacity that is below 80% of normal value for respective race, age, height, and gender or below 2.5 Liters (L) of absolute volume 6. Pulse oximetry below 95% 7. Body weight less than 50 kg (110 pounds) or a Body Mass Index (BMI) of ≥ 32 8. Reported use of any botulinum toxin within 3 months prior to the date of surgery 9. Use of long acting opioids within 3 days or any opioid medication within 24 hours prior to surgery 10. Aminoglycoside intake within 48 hours prior to or during surgery 11. Participants on anti-depressant or anti-psychotic medications 12. Reported pain score of 2 or more at screening on the 11-point scale numerical pain rating scale-administered after an activity (NPRS-A) following an activity after and walking approximately 10 feet.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC) of Participant's Assessment of Pain Using the Numerical Pain Rating Scale (NPRS) at Rest Between 12 and 96 Hours Postsurgery (AUC12-96) | Every 2 hours from 12 to 96 hours postsurgery | The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 72 Hours Postsurgery (AUC0-72) | Every 2 hours from 0 to 72 hours postsurgery | The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule. |
| AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 48 Hours Postsurgery (AUC0-48) | Every 2 hours from 0 to 48 hours postsurgery | The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule. |
| AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 24 Hours Postsurgery (AUC0-24) | Every 2 hours from 0 to 24 hours postsurgery | The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule. |
| AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 12 and 24 Hours Postsurgery (AUC12-24) | Every 2 hours from 12 to 24 hours postsurgery | The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule. |
| AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 96 Hours Postsurgery | Every 2 hours from 0 to 96 hours postsurgery | The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule. |
| Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 8, 16, 24, 30, 36, 42, 48, 54, 60, 66, 72.78.84, and 96 hours after surgery; Days 8, 15 and 29 after discharge | The participant assessed their pain using the 11-point NPRS-A, after sitting up in the bed unassisted at an angle of approximately ≥ 45 degrees, swinging legs out, putting feet down, standing up, and walking approximately 10 feet, where: 0=no pain to 10=worst pain imaginable. |
| Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Days 5, 8, 15 and 29 | The participant assessed their overall pain control in the past 24 hours using the PGA 4-point scale where: 0=poor, 1=fair, 2=good and 3=excellent. |
| Number of Doses of Rescue Medications Used | Up to 96 hours postsurgery | — |
| Participants Overall Assessment of Pain Using the NPRS After Discharge | Days 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24 and 26 | The participant assessed their pain after discharge using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery. | 12 |
| Botulinum Neurotoxin Serotype E Dose 1 Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery. | 4 |
| Botulinum Neurotoxin Serotype E Dose 2 Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery. | 4 |
| Botulinum Neurotoxin Serotype E Dose 3 Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery. | 3 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Botulinum Neurotoxin Serotype E Dose 1 | Botulinum Neurotoxin Serotype E Dose 2 | Botulinum Neurotoxin Serotype E Dose 3 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 36.5 years STANDARD_DEVIATION 5.2 | 33.0 years STANDARD_DEVIATION 6.38 | 36.3 years STANDARD_DEVIATION 7.72 | 41.0 years STANDARD_DEVIATION 14 | 36.7 years STANDARD_DEVIATION 3.29 |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 3 Participants | 1 Participants | 2 Participants | 11 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 6 Participants | 1 Participants | 2 Participants | 1 Participants | 10 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 6 Participants | 3 Participants | 2 Participants | 2 Participants | 13 Participants |
| Race/Ethnicity, Customized Other/Mixed | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White or Caucasian | 6 Participants | 1 Participants | 2 Participants | 1 Participants | 10 Participants |
| Sex: Female, Male Female | 11 Participants | 4 Participants | 4 Participants | 3 Participants | 22 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 4 | 0 / 4 | 0 / 3 |
| other Total, other adverse events | 8 / 12 | 3 / 4 | 4 / 4 | 3 / 3 |
| serious Total, serious adverse events | 0 / 12 | 0 / 4 | 0 / 4 | 0 / 3 |
Outcome results
Primary
Area Under the Curve (AUC) of Participant's Assessment of Pain Using the Numerical Pain Rating Scale (NPRS) at Rest Between 12 and 96 Hours Postsurgery (AUC12-96)
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
Time frame: Every 2 hours from 12 to 96 hours postsurgery
Population: Modified Intent-to-treat (mITT) population included all randomized and treated participants with at least one post-injection pain score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Curve (AUC) of Participant's Assessment of Pain Using the Numerical Pain Rating Scale (NPRS) at Rest Between 12 and 96 Hours Postsurgery (AUC12-96) | 321.18 hour (hr)*score on a scale | Standard Deviation 217.993 |
| Botulinum Neurotoxin Serotype E Dose 1 | Area Under the Curve (AUC) of Participant's Assessment of Pain Using the Numerical Pain Rating Scale (NPRS) at Rest Between 12 and 96 Hours Postsurgery (AUC12-96) | 209.30 hour (hr)*score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 2 | Area Under the Curve (AUC) of Participant's Assessment of Pain Using the Numerical Pain Rating Scale (NPRS) at Rest Between 12 and 96 Hours Postsurgery (AUC12-96) | 415.40 hour (hr)*score on a scale | Standard Deviation 124.101 |
| Botulinum Neurotoxin Serotype E Dose 3 | Area Under the Curve (AUC) of Participant's Assessment of Pain Using the Numerical Pain Rating Scale (NPRS) at Rest Between 12 and 96 Hours Postsurgery (AUC12-96) | 372.53 hour (hr)*score on a scale | Standard Deviation 135.799 |
Secondary
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 24 Hours Postsurgery (AUC0-24)
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
Time frame: Every 2 hours from 0 to 24 hours postsurgery
Population: mITT population included all randomized and treated participants with at least one post-injection pain score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 24 Hours Postsurgery (AUC0-24) | 144.49 hr*score on a scale | Standard Deviation 46.693 |
| Botulinum Neurotoxin Serotype E Dose 1 | AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 24 Hours Postsurgery (AUC0-24) | 149.80 hr*score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 2 | AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 24 Hours Postsurgery (AUC0-24) | 155.53 hr*score on a scale | Standard Deviation 28.726 |
| Botulinum Neurotoxin Serotype E Dose 3 | AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 24 Hours Postsurgery (AUC0-24) | 146.30 hr*score on a scale | Standard Deviation 21.717 |
Secondary
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 48 Hours Postsurgery (AUC0-48)
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
Time frame: Every 2 hours from 0 to 48 hours postsurgery
Population: mITT population included all randomized and treated participants with at least one post-injection pain score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 48 Hours Postsurgery (AUC0-48) | 253.53 hr*score on a scale | Standard Deviation 106.862 |
| Botulinum Neurotoxin Serotype E Dose 1 | AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 48 Hours Postsurgery (AUC0-48) | 240.80 hr*score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 2 | AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 48 Hours Postsurgery (AUC0-48) | 283.20 hr*score on a scale | Standard Deviation 60.45 |
| Botulinum Neurotoxin Serotype E Dose 3 | AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 48 Hours Postsurgery (AUC0-48) | 274.47 hr*score on a scale | Standard Deviation 32.686 |
Secondary
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 72 Hours Postsurgery (AUC0-72)
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
Time frame: Every 2 hours from 0 to 72 hours postsurgery
Population: mITT population included all randomized and treated participants with at least one post-injection pain score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 72 Hours Postsurgery (AUC0-72) | 338.91 hr*score on a scale | Standard Deviation 173.785 |
| Botulinum Neurotoxin Serotype E Dose 1 | AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 72 Hours Postsurgery (AUC0-72) | 280.50 hr*score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 2 | AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 72 Hours Postsurgery (AUC0-72) | 416.70 hr*score on a scale | Standard Deviation 97.464 |
| Botulinum Neurotoxin Serotype E Dose 3 | AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 72 Hours Postsurgery (AUC0-72) | 372.47 hr*score on a scale | Standard Deviation 86.226 |
Secondary
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 96 Hours Postsurgery
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
Time frame: Every 2 hours from 0 to 96 hours postsurgery
Population: mITT population included all randomized and treated participants with at least one post-injection pain score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 96 Hours Postsurgery | 403.80 hr*score on a scale | Standard Deviation 229.152 |
| Botulinum Neurotoxin Serotype E Dose 1 | AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 96 Hours Postsurgery | 282.50 hr*score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 2 | AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 96 Hours Postsurgery | 506.83 hr*score on a scale | Standard Deviation 130.598 |
| Botulinum Neurotoxin Serotype E Dose 3 | AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 96 Hours Postsurgery | 450.97 hr*score on a scale | Standard Deviation 139.769 |
Secondary
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 12 and 24 Hours Postsurgery (AUC12-24)
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
Time frame: Every 2 hours from 12 to 24 hours postsurgery
Population: mITT population included all randomized and treated participants with at least one post-injection pain score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 12 and 24 Hours Postsurgery (AUC12-24) | 61.91 hr*score on a scale | Standard Deviation 32.21 |
| Botulinum Neurotoxin Serotype E Dose 1 | AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 12 and 24 Hours Postsurgery (AUC12-24) | 76.60 hr*score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 2 | AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 12 and 24 Hours Postsurgery (AUC12-24) | 64.10 hr*score on a scale | Standard Deviation 22.825 |
| Botulinum Neurotoxin Serotype E Dose 3 | AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 12 and 24 Hours Postsurgery (AUC12-24) | 67.83 hr*score on a scale | Standard Deviation 18.827 |
Secondary
Number of Doses of Rescue Medications Used
Time frame: Up to 96 hours postsurgery
Population: mITT population included all randomized and treated participants with at least one post-injection pain score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Doses of Rescue Medications Used | Oxycodone | 9.7 doses | Standard Deviation 5.92 |
| Placebo | Number of Doses of Rescue Medications Used | Opioid | 14.2 doses | Standard Deviation 7.4 |
| Botulinum Neurotoxin Serotype E Dose 1 | Number of Doses of Rescue Medications Used | Opioid | 8.0 doses | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Number of Doses of Rescue Medications Used | Oxycodone | 5.0 doses | — |
| Botulinum Neurotoxin Serotype E Dose 2 | Number of Doses of Rescue Medications Used | Opioid | 15.8 doses | Standard Deviation 6.9 |
| Botulinum Neurotoxin Serotype E Dose 2 | Number of Doses of Rescue Medications Used | Oxycodone | 11.8 doses | Standard Deviation 5.68 |
| Botulinum Neurotoxin Serotype E Dose 3 | Number of Doses of Rescue Medications Used | Opioid | 16.0 doses | Standard Deviation 6.08 |
| Botulinum Neurotoxin Serotype E Dose 3 | Number of Doses of Rescue Medications Used | Oxycodone | 11.7 doses | Standard Deviation 4.93 |
Secondary
Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories
The participant assessed their overall pain control in the past 24 hours using the PGA 4-point scale where: 0=poor, 1=fair, 2=good and 3=excellent.
Time frame: Days 5, 8, 15 and 29
Population: mITT population included all randomized and treated participants with at least one post-injection pain score.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 5 | PGA score 3 | 7 Participants |
| Placebo | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 8 | PGA score 3 | 7 Participants |
| Placebo | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 29 | PGA score 2 | 2 Participants |
| Placebo | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 8 | PGA score 0 | 0 Participants |
| Placebo | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 5 | PGA score 2 | 4 Participants |
| Placebo | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 8 | PGA score 2 | 4 Participants |
| Placebo | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 29 | PGA score 3 | 9 Participants |
| Placebo | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 8 | PGA score 1 | 0 Participants |
| Placebo | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 15 | PGA score 0 | 0 Participants |
| Placebo | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 29 | PGA score 1 | 0 Participants |
| Placebo | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 15 | PGA score 1 | 0 Participants |
| Placebo | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 15 | PGA score 2 | 3 Participants |
| Placebo | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 5 | PGA score 1 | 0 Participants |
| Placebo | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 29 | PGA score 0 | 0 Participants |
| Placebo | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 5 | PGA score 0 | 0 Participants |
| Placebo | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 15 | PGA score 3 | 8 Participants |
| Botulinum Neurotoxin Serotype E Dose 1 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 15 | PGA score 0 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 1 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 29 | PGA score 3 | 1 Participants |
| Botulinum Neurotoxin Serotype E Dose 1 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 29 | PGA score 2 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 1 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 5 | PGA score 0 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 1 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 29 | PGA score 1 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 1 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 29 | PGA score 0 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 1 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 8 | PGA score 3 | 1 Participants |
| Botulinum Neurotoxin Serotype E Dose 1 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 8 | PGA score 2 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 1 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 5 | PGA score 2 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 1 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 8 | PGA score 1 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 1 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 8 | PGA score 0 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 1 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 5 | PGA score 3 | 1 Participants |
| Botulinum Neurotoxin Serotype E Dose 1 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 15 | PGA score 3 | 1 Participants |
| Botulinum Neurotoxin Serotype E Dose 1 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 15 | PGA score 2 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 1 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 5 | PGA score 1 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 1 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 15 | PGA score 1 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 2 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 29 | PGA score 2 | 1 Participants |
| Botulinum Neurotoxin Serotype E Dose 2 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 29 | PGA score 0 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 2 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 15 | PGA score 0 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 2 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 15 | PGA score 1 | 1 Participants |
| Botulinum Neurotoxin Serotype E Dose 2 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 15 | PGA score 3 | 2 Participants |
| Botulinum Neurotoxin Serotype E Dose 2 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 5 | PGA score 0 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 2 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 29 | PGA score 1 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 2 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 5 | PGA score 1 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 2 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 15 | PGA score 2 | 1 Participants |
| Botulinum Neurotoxin Serotype E Dose 2 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 8 | PGA score 2 | 2 Participants |
| Botulinum Neurotoxin Serotype E Dose 2 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 5 | PGA score 3 | 2 Participants |
| Botulinum Neurotoxin Serotype E Dose 2 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 8 | PGA score 1 | 1 Participants |
| Botulinum Neurotoxin Serotype E Dose 2 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 5 | PGA score 2 | 2 Participants |
| Botulinum Neurotoxin Serotype E Dose 2 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 8 | PGA score 3 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 2 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 29 | PGA score 3 | 3 Participants |
| Botulinum Neurotoxin Serotype E Dose 2 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 8 | PGA score 0 | 1 Participants |
| Botulinum Neurotoxin Serotype E Dose 3 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 8 | PGA score 0 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 3 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 5 | PGA score 3 | 1 Participants |
| Botulinum Neurotoxin Serotype E Dose 3 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 5 | PGA score 2 | 1 Participants |
| Botulinum Neurotoxin Serotype E Dose 3 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 5 | PGA score 1 | 1 Participants |
| Botulinum Neurotoxin Serotype E Dose 3 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 5 | PGA score 0 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 3 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 8 | PGA score 3 | 1 Participants |
| Botulinum Neurotoxin Serotype E Dose 3 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 8 | PGA score 2 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 3 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 8 | PGA score 1 | 2 Participants |
| Botulinum Neurotoxin Serotype E Dose 3 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 29 | PGA score 0 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 3 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 15 | PGA score 3 | 1 Participants |
| Botulinum Neurotoxin Serotype E Dose 3 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 15 | PGA score 2 | 1 Participants |
| Botulinum Neurotoxin Serotype E Dose 3 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 15 | PGA score 1 | 1 Participants |
| Botulinum Neurotoxin Serotype E Dose 3 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 15 | PGA score 0 | 0 Participants |
| Botulinum Neurotoxin Serotype E Dose 3 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 29 | PGA score 3 | 1 Participants |
| Botulinum Neurotoxin Serotype E Dose 3 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 29 | PGA score 2 | 2 Participants |
| Botulinum Neurotoxin Serotype E Dose 3 | Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | Day 29 | PGA score 1 | 0 Participants |
Secondary
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A)
The participant assessed their pain using the 11-point NPRS-A, after sitting up in the bed unassisted at an angle of approximately ≥ 45 degrees, swinging legs out, putting feet down, standing up, and walking approximately 10 feet, where: 0=no pain to 10=worst pain imaginable.
Time frame: 8, 16, 24, 30, 36, 42, 48, 54, 60, 66, 72.78.84, and 96 hours after surgery; Days 8, 15 and 29 after discharge
Population: mITT population included all randomized and treated participants with at least one post-injection pain score. Participants analyzed is the number of participants with data available for analysis at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 48 hours after surgery | 4.3 score on a scale | Standard Deviation 1.5 |
| Placebo | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 60 hours after surgery | 6.3 score on a scale | Standard Deviation 2.75 |
| Placebo | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 66 hours after surgery | 4.7 score on a scale | Standard Deviation 3.2 |
| Placebo | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 84 hours after surgery | 4.5 score on a scale | Standard Deviation 3.32 |
| Placebo | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 96 hours after surgery | 2.4 score on a scale | Standard Deviation 1.81 |
| Placebo | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | Day 8 after discharge | 2.1 score on a scale | Standard Deviation 2.2 |
| Placebo | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | Day 15 after discharge | 1.6 score on a scale | Standard Deviation 1.77 |
| Placebo | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | Day 29 after discharge | 1.5 score on a scale | Standard Deviation 1.97 |
| Placebo | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 42 hours after surgery | 5.8 score on a scale | Standard Deviation 1.47 |
| Placebo | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 8 hours after surgery | 6.9 score on a scale | Standard Deviation 2.74 |
| Placebo | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 16 hours after surgery | 8.7 score on a scale | Standard Deviation 1.53 |
| Placebo | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 24 hours after surgery | 6.6 score on a scale | Standard Deviation 2.4 |
| Placebo | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 30 hours after surgery | 6.5 score on a scale | Standard Deviation 2.45 |
| Placebo | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 36 hours after surgery | 6.3 score on a scale | Standard Deviation 1.89 |
| Placebo | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 54 hours after surgery | 4.8 score on a scale | Standard Deviation 1.2 |
| Placebo | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 72 hours after surgery | 3.7 score on a scale | Standard Deviation 2.45 |
| Placebo | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 78 hours after surgery | 3.6 score on a scale | Standard Deviation 2.62 |
| Botulinum Neurotoxin Serotype E Dose 1 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 8 hours after surgery | 5.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 24 hours after surgery | 5.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 30 hours after surgery | 5.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 78 hours after surgery | 0.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 16 hours after surgery | 4.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 72 hours after surgery | 0.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | Day 15 after discharge | 0.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | Day 8 after discharge | 1.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 54 hours after surgery | 2.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 96 hours after surgery | 0.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 60 hours after surgery | 3.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 48 hours after surgery | 3.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 84 hours after surgery | 1.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 36 hours after surgery | 4.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 2 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 78 hours after surgery | 4.5 score on a scale | Standard Deviation 2.08 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | Day 8 after discharge | 4.8 score on a scale | Standard Deviation 1.71 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | Day 15 after discharge | 3.8 score on a scale | Standard Deviation 2.99 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | Day 29 after discharge | 0.5 score on a scale | Standard Deviation 0.58 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 48 hours after surgery | 5.3 score on a scale | Standard Deviation 1.71 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 8 hours after surgery | 6.0 score on a scale | Standard Deviation 2.45 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 24 hours after surgery | 7.5 score on a scale | Standard Deviation 1.29 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 72 hours after surgery | 4.0 score on a scale | Standard Deviation 2.71 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 30 hours after surgery | 7.0 score on a scale | Standard Deviation 2.16 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 54 hours after surgery | 6.3 score on a scale | Standard Deviation 3.1 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 60 hours after surgery | 6.0 score on a scale | Standard Deviation 1.41 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 36 hours after surgery | 6.5 score on a scale | Standard Deviation 1.29 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 84 hours after surgery | 5.0 score on a scale | Standard Deviation 1.15 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 96 hours after surgery | 3.5 score on a scale | Standard Deviation 1.29 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 54 hours after surgery | 4.0 score on a scale | Standard Deviation 2 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 72 hours after surgery | 3.0 score on a scale | Standard Deviation 1.73 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 84 hours after surgery | 3.0 score on a scale | Standard Deviation 2.65 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 60 hours after surgery | 3.3 score on a scale | Standard Deviation 2.52 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 36 hours after surgery | 6.3 score on a scale | Standard Deviation 0.58 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | Day 15 after discharge | 2.7 score on a scale | Standard Deviation 2.31 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | Day 29 after discharge | 0.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 3 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 16 hours after surgery | 7.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 3 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 96 hours after surgery | 3.3 score on a scale | Standard Deviation 3.06 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 24 hours after surgery | 6.3 score on a scale | Standard Deviation 0.58 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 78 hours after surgery | 3.3 score on a scale | Standard Deviation 2.08 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 8 hours after surgery | 6.3 score on a scale | Standard Deviation 0.58 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | Day 8 after discharge | 3.3 score on a scale | Standard Deviation 3.06 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 30 hours after surgery | 5.0 score on a scale | Standard Deviation 2 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | 48 hours after surgery | 3.7 score on a scale | Standard Deviation 1.53 |
Secondary
Participants Overall Assessment of Pain Using the NPRS After Discharge
The participant assessed their pain after discharge using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable.
Time frame: Days 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24 and 26
Population: mITT population included all randomized and treated participants with at least one post-injection pain score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 18 | 1.6 score on a scale | Standard Deviation 2.26 |
| Placebo | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 16 | 1.9 score on a scale | Standard Deviation 2.47 |
| Placebo | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 13 | 1.7 score on a scale | Standard Deviation 1.73 |
| Placebo | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 10 | 1.8 score on a scale | Standard Deviation 1.92 |
| Placebo | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 12 | 1.7 score on a scale | Standard Deviation 1.87 |
| Placebo | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 11 | 1.8 score on a scale | Standard Deviation 2.28 |
| Placebo | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 14 | 1.7 score on a scale | Standard Deviation 1.94 |
| Placebo | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 24 | 1.5 score on a scale | Standard Deviation 2.45 |
| Placebo | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 22 | 1.1 score on a scale | Standard Deviation 1.73 |
| Placebo | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 7 | 2.3 score on a scale | Standard Deviation 2.78 |
| Placebo | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 9 | 2.1 score on a scale | Standard Deviation 2.62 |
| Placebo | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 6 | 2.3 score on a scale | Standard Deviation 1.66 |
| Placebo | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 20 | 1.6 score on a scale | Standard Deviation 2.2 |
| Placebo | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 8 | 1.8 score on a scale | Standard Deviation 1.79 |
| Placebo | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 26 | 1.3 score on a scale | Standard Deviation 1.98 |
| Botulinum Neurotoxin Serotype E Dose 1 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 20 | 0.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 6 | 0.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 9 | 0.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 10 | 0.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 7 | 0.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 8 | 0.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 11 | 0.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 12 | 0.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 13 | 0.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 14 | 0.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 16 | 0.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 18 | 0.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 22 | 0.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 24 | 0.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 1 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 26 | 0.0 score on a scale | — |
| Botulinum Neurotoxin Serotype E Dose 2 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 26 | 1.0 score on a scale | Standard Deviation 1.41 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 13 | 3.0 score on a scale | Standard Deviation 0 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 24 | 1.0 score on a scale | Standard Deviation 1.41 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 14 | 2.3 score on a scale | Standard Deviation 1.71 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 9 | 5.3 score on a scale | Standard Deviation 1.5 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 16 | 2.0 score on a scale | Standard Deviation 0.82 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 8 | 3.5 score on a scale | Standard Deviation 1.73 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 18 | 1.8 score on a scale | Standard Deviation 0.96 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 7 | 3.8 score on a scale | Standard Deviation 0.5 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 20 | 1.8 score on a scale | Standard Deviation 0.96 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 6 | 6.0 score on a scale | Standard Deviation 1.83 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 22 | 1.0 score on a scale | Standard Deviation 1.41 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 11 | 3.3 score on a scale | Standard Deviation 1.5 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 10 | 4.0 score on a scale | Standard Deviation 0.82 |
| Botulinum Neurotoxin Serotype E Dose 2 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 12 | 2.5 score on a scale | Standard Deviation 1.29 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 9 | 1.5 score on a scale | Standard Deviation 2.12 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 11 | 1.5 score on a scale | Standard Deviation 2.12 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 13 | 2.0 score on a scale | Standard Deviation 2.83 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 20 | 1.5 score on a scale | Standard Deviation 2.12 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 12 | 1.5 score on a scale | Standard Deviation 2.12 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 14 | 2.0 score on a scale | Standard Deviation 2.83 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 26 | 1.5 score on a scale | Standard Deviation 2.12 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 24 | 2.0 score on a scale | Standard Deviation 2.83 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 8 | 3.0 score on a scale | Standard Deviation 3 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 16 | 1.5 score on a scale | Standard Deviation 2.12 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 10 | 1.5 score on a scale | Standard Deviation 2.12 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 6 | 2.3 score on a scale | Standard Deviation 2.08 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 22 | 1.5 score on a scale | Standard Deviation 2.12 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 18 | 1.5 score on a scale | Standard Deviation 2.12 |
| Botulinum Neurotoxin Serotype E Dose 3 | Participants Overall Assessment of Pain Using the NPRS After Discharge | Day 7 | 3.0 score on a scale | Standard Deviation 3 |