Trial Outcomes & Findings for A Study To Assess the Adverse Effects and Change in Condition of OnabotulinumtoxinA X Injection in Adult Participants With Forehead Lines (NCT NCT05152576)
NCT ID: NCT05152576
Last Updated: 2025-07-16
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
Day 1 to Day 180
Results posted on
2025-07-16
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose A
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose B
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose C
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
35
|
31
|
28
|
|
Overall Study
COMPLETED
|
25
|
34
|
31
|
26
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Placebo will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose A
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose B
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose C
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
|
Overall Study
Other
|
2
|
0
|
0
|
0
|
Baseline Characteristics
A Study To Assess the Adverse Effects and Change in Condition of OnabotulinumtoxinA X Injection in Adult Participants With Forehead Lines
Baseline characteristics by cohort
| Measure |
Placebo
n=30 Participants
Placebo will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose A
n=35 Participants
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose B
n=31 Participants
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose C
n=28 Participants
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.1 years
STANDARD_DEVIATION 12.33 • n=99 Participants
|
43.7 years
STANDARD_DEVIATION 11.97 • n=107 Participants
|
46.6 years
STANDARD_DEVIATION 11.82 • n=206 Participants
|
50.5 years
STANDARD_DEVIATION 12.87 • n=157 Participants
|
46.6 years
STANDARD_DEVIATION 12.32 • n=390 Participants
|
|
Age, Customized
18-25
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
5 Participants
n=390 Participants
|
|
Age, Customized
26-40
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
8 Participants
n=157 Participants
|
35 Participants
n=390 Participants
|
|
Age, Customized
41-55
|
11 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
9 Participants
n=157 Participants
|
49 Participants
n=390 Participants
|
|
Age, Customized
56-64
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
7 Participants
n=157 Participants
|
29 Participants
n=390 Participants
|
|
Age, Customized
>=65
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
6 Participants
n=390 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
26 Participants
n=157 Participants
|
108 Participants
n=390 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
16 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=157 Participants
|
19 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
22 Participants
n=157 Participants
|
105 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
3 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
2 Participants
n=390 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
26 Participants
n=157 Participants
|
118 Participants
n=390 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 180Population: Safety population
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Outcome measures
| Measure |
Placebo
n=29 Participants
Placebo will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose A
n=35 Participants
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose B
n=31 Participants
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose C
n=28 Participants
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
10 Participants
|
12 Participants
|
18 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 180Population: Safety population Overall Number of Participants Analyzed = Except for Temperature, number of subjects with an available baseline value and at least 1 postbaseline assessment; for Temperature, number of subjects with at least 1 postbaseline assessment.
Percentage of participants with potentially clinically significant vital sign measurements like systolic and diastolic blood pressure will be assessed.
Outcome measures
| Measure |
Placebo
n=29 Participants
Placebo will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose A
n=35 Participants
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose B
n=31 Participants
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose C
n=27 Participants
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Potentially Clinically Significant Vital Sign Parameters
Systolic Blood Pressure (mmHg): ≥ 160 and Increase of ≥ 20
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Percentage of Participants With Potentially Clinically Significant Vital Sign Parameters
Systolic Blood Pressure (mmHg): ≤ 90 and Decrease of ≥ 20
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Percentage of Participants With Potentially Clinically Significant Vital Sign Parameters
Diastolic Blood Pressure (mmHg): ≥ 100 and Increase of ≥ 15
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants With Potentially Clinically Significant Vital Sign Parameters
Diastolic Blood Pressure (mmHg): ≤ 50 and Decrease of ≥ 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants With Potentially Clinically Significant Vital Sign Parameters
Heart Rate (beats/min): ≥ 110 and Increase of ≥ 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants With Potentially Clinically Significant Vital Sign Parameters
Heart Rate (beats/min): ≤ 50 and Decrease of ≥ 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants With Potentially Clinically Significant Vital Sign Parameters
Temperature (C): ≥ 38.3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 30Population: Intent-to-Treat Population Overall Number of Participants Analyzed = Number of subjects with data at baseline and the visit.
Facial Wrinkle Scale - Forehead Lines (FWS-FHL) at maximum contraction (also known as eyebrow elevation) The Clinician Forehead Lines Scale is a four point scale used to assess the severity of forehead lines at maximum contraction ranging from 0 - None to 3 - Severe.
Outcome measures
| Measure |
Placebo
n=29 Participants
Placebo will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose A
n=34 Participants
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose B
n=31 Participants
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose C
n=27 Participants
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Achievement of ≥ 1-grade Improvement From Baseline on the Investigator-rated Clinician Forehead Lines Scale at Maximum Contraction.
|
58.6 percentage of participants
Interval 40.7 to 76.5
|
100 percentage of participants
Interval 100.0 to 100.0
|
96.8 percentage of participants
Interval 90.6 to 100.0
|
100 percentage of participants
Interval 100.0 to 100.0
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
OnabotulinumtoxinA X Dose A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
OnabotulinumtoxinA X Dose B
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
OnabotulinumtoxinA X Dose C
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=30 participants at risk
Placebo will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose A
n=35 participants at risk
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose B
n=31 participants at risk
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose C
n=28 participants at risk
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
|---|---|---|---|---|
|
Infections and infestations
KIDNEY INFECTION
|
3.3%
1/30 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/35 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/31 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
Other adverse events
| Measure |
Placebo
n=30 participants at risk
Placebo will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose A
n=35 participants at risk
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose B
n=31 participants at risk
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
OnabotulinumtoxinA X Dose C
n=28 participants at risk
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
|
|---|---|---|---|---|
|
Eye disorders
EYELID PTOSIS
|
0.00%
0/30 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/35 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/31 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
10.7%
3/28 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
|
General disorders
INJECTION SITE BRUISING
|
0.00%
0/30 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/35 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
7.1%
2/28 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
|
General disorders
INJECTION SITE PAIN
|
3.3%
1/30 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/35 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
7.1%
2/28 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
|
General disorders
INJECTION SITE SWELLING
|
3.3%
1/30 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
7.1%
2/28 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
|
Infections and infestations
ASYMPTOMATIC COVID-19
|
0.00%
0/30 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
|
Infections and infestations
COVID-19
|
3.3%
1/30 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
11.4%
4/35 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
16.1%
5/31 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
10.7%
3/28 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/30 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/35 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/31 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
7.1%
2/28 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
|
Nervous system disorders
HEADACHE
|
10.0%
3/30 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
7.1%
2/28 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place