Trial Outcomes & Findings for BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence (NCT NCT04073303)
NCT ID: NCT04073303
Last Updated: 2025-05-06
Results Overview
Proportion of participants who achieve ≥ 2-grade improvement from baseline at Day 90, per investigator assessments of MMP using the Masseter Muscle Prominence Scale (MMPS). MMPS ranges from 1 = minimal to 5 = very marked.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
377 participants
Primary outcome timeframe
Day 90
Results posted on
2025-05-06
Participant Flow
A total of 377 participants were enrolled and randomized into the study; 284 to BOTOX and 93 to Placebo. A total of 370 participants were included in the modified ITT (mITT) Population; 278 to BOTOX and 92 to Placebo. A participant was considered to have completed the study if he/she had at least completed the treatment visit and the end of study visit.
The mITT population, consisting of all randomized subjects with at least 1 postbaseline MMPS assessment, comprised 370 subjects.
Participant milestones
| Measure |
Placebo
Placebo was administered as bilateral intramuscular injections into the masseter on Day 1.
|
BOTOX®
BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
284
|
|
Overall Study
mITT Population
|
92
|
278
|
|
Overall Study
COMPLETED
|
70
|
240
|
|
Overall Study
NOT COMPLETED
|
23
|
44
|
Reasons for withdrawal
| Measure |
Placebo
Placebo was administered as bilateral intramuscular injections into the masseter on Day 1.
|
BOTOX®
BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
16
|
36
|
|
Overall Study
Lost to Follow-up
|
6
|
1
|
|
Overall Study
Protocol Deviation
|
0
|
4
|
|
Overall Study
Other
|
1
|
1
|
Baseline Characteristics
BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence
Baseline characteristics by cohort
| Measure |
Placebo
n=92 Participants
Placebo was administered as bilateral intramuscular injections into the masseter on Day 1
|
BOTOX®
n=278 Participants
BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments
|
Total
n=370 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.0 years
STANDARD_DEVIATION 8.67 • n=5 Participants
|
31.5 years
STANDARD_DEVIATION 8.35 • n=7 Participants
|
31.4 years
STANDARD_DEVIATION 8.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
244 Participants
n=7 Participants
|
326 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
91 Participants
n=5 Participants
|
274 Participants
n=7 Participants
|
365 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
76 Participants
n=5 Participants
|
247 Participants
n=7 Participants
|
323 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Masseter Muscle Prominence Scale (MMPS)
4 = Marked
|
59 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
|
Baseline Masseter Muscle Prominence Scale (MMPS)
5 = Very Marked
|
33 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 90Population: mITT Population
Proportion of participants who achieve ≥ 2-grade improvement from baseline at Day 90, per investigator assessments of MMP using the Masseter Muscle Prominence Scale (MMPS). MMPS ranges from 1 = minimal to 5 = very marked.
Outcome measures
| Measure |
Placebo
n=92 Participants
Placebo was administered as bilateral intramuscular injections into the masseter on Day 1.
|
BOTOX®
n=278 Participants
BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments
|
|---|---|---|
|
Achievement of ≥ 2-Grade Improvement From Baseline on the Masseter Muscle Prominence Scale (MMPS) at Day 90
|
2.2 percentage of participants
Interval 0.0 to 5.2
|
51.2 percentage of participants
Interval 45.2 to 57.2
|
SECONDARY outcome
Timeframe: Day 90Population: mITT Population
Proportion of participants who achieve MMPS Grade of ≤ 3 at Day 90, per investigator assessments of MMP using the Masseter Muscle Prominence Scale (MMPS). MMPS ranges from 1 = minimal to 5 = very marked.
Outcome measures
| Measure |
Placebo
n=92 Participants
Placebo was administered as bilateral intramuscular injections into the masseter on Day 1.
|
BOTOX®
n=278 Participants
BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments
|
|---|---|---|
|
Achievement of MMPS Grade ≤ 3 at Day 90
|
9.9 percentage of participants
Interval 3.8 to 16.1
|
81.1 percentage of participants
Interval 76.4 to 85.9
|
SECONDARY outcome
Timeframe: Day 90Population: mITT Population
Proportion of participants who achieve MMPS-P Grade ≤ 3 at Day 90, according to participant, per Masseter Muscle Prominence Scale-Participant (MMPS-P) MMPS-P ranges from 1 = not at all pronounced to 5 = very pronounced.
Outcome measures
| Measure |
Placebo
n=92 Participants
Placebo was administered as bilateral intramuscular injections into the masseter on Day 1.
|
BOTOX®
n=278 Participants
BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments
|
|---|---|---|
|
Achievement of MMPS-P Grade ≤ 3 on Day 90
|
19.5 percentage of participants
Interval 11.2 to 27.8
|
76.2 percentage of participants
Interval 71.1 to 81.4
|
SECONDARY outcome
Timeframe: Day 90Population: mITT Population
Proportion of participants who achieve ≥ 2-grade improvement from baseline at Day 90, per Masseter Muscle Prominence Scale-Participant (MMPS-P) MMPS-P ranges from 1 = not at all pronounced to 5 = very pronounced.
Outcome measures
| Measure |
Placebo
n=92 Participants
Placebo was administered as bilateral intramuscular injections into the masseter on Day 1.
|
BOTOX®
n=278 Participants
BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments
|
|---|---|---|
|
Achievement of MMPS-P ≥ 2-Grade Improvement From Baseline at Day 90
|
9.1 percentage of participants
Interval 3.1 to 15.0
|
58.8 percentage of participants
Interval 52.9 to 64.7
|
SECONDARY outcome
Timeframe: Day 90Population: mITT Population
Proportion of participants who achieve Grade ≥ 1 on Participant Self-Assessment of Change (PSAC) (at least minimally improved from baseline) at Day 90 PSAC ranges from 3 = much improved to -3 = much worse.
Outcome measures
| Measure |
Placebo
n=92 Participants
Placebo was administered as bilateral intramuscular injections into the masseter on Day 1.
|
BOTOX®
n=278 Participants
BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments
|
|---|---|---|
|
Achievement of PSAC Grade ≥ 1 (at Least Minimally Improved From Baseline) on Day 90
|
20.4 percentage of participants
Interval 12.0 to 28.7
|
90.8 percentage of participants
Interval 87.3 to 94.4
|
SECONDARY outcome
Timeframe: Day 90Population: mITT Population
Calculated from standardized images, measured in millimeters (mm)
Outcome measures
| Measure |
Placebo
n=92 Participants
Placebo was administered as bilateral intramuscular injections into the masseter on Day 1.
|
BOTOX®
n=278 Participants
BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments
|
|---|---|---|
|
Change From Baseline in Lower Facial Width (mm) at Day 90
|
-0.04 millimeters (mm)
Standard Error 0.202
|
-5.24 millimeters (mm)
Standard Error 0.121
|
SECONDARY outcome
Timeframe: Up to Day 360Population: mITT Population
Median duration of effect for BOTOX-treated MMPS responders.
Outcome measures
| Measure |
Placebo
n=278 Participants
Placebo was administered as bilateral intramuscular injections into the masseter on Day 1.
|
BOTOX®
BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments
|
|---|---|---|
|
Median Duration of Effect for MMPS Responders
MMPS ≥ 1-Grade Improvement
|
268.0 Days
Interval 239.0 to 304.0
|
—
|
|
Median Duration of Effect for MMPS Responders
MMPS ≥ 2-Grade Improvement
|
176.0 Days
Interval 154.0 to 183.0
|
—
|
|
Median Duration of Effect for MMPS Responders
MMPS Grade ≤ 3
|
213.0 Days
Interval 204.0 to 236.0
|
—
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
BOTOX®
Serious events: 11 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=93 participants at risk
Placebo was administered as bilateral intramuscular injections into the masseter on Day 1
|
BOTOX®
n=283 participants at risk
BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments
|
|---|---|---|
|
Cardiac disorders
VENTRICULAR EXTRASYSTOLES
|
0.00%
0/93 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
0.35%
1/283 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/93 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
0.35%
1/283 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
|
Hepatobiliary disorders
GALLBLADDER POLYP
|
0.00%
0/93 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
0.35%
1/283 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
|
Infections and infestations
POST-ACUTE COVID-19 SYNDROME
|
0.00%
0/93 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
0.35%
1/283 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
0.00%
0/93 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
0.35%
1/283 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
|
Nervous system disorders
POST HERPETIC NEURALGIA
|
1.1%
1/93 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
0.00%
0/283 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION OF ECTOPIC PREGNANCY
|
0.00%
0/93 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
0.35%
1/283 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION THREATENED
|
0.00%
0/93 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
0.35%
1/283 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
|
Pregnancy, puerperium and perinatal conditions
FOETAL GROWTH RESTRICTION
|
0.00%
0/93 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
0.35%
1/283 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
|
Reproductive system and breast disorders
ENDOMETRIOSIS
|
1.1%
1/93 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
0.00%
0/283 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
|
Reproductive system and breast disorders
FALLOPIAN TUBE CYST
|
0.00%
0/93 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
0.35%
1/283 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG OPACITY
|
0.00%
0/93 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
0.35%
1/283 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL SEPTUM DEVIATION
|
1.1%
1/93 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
0.00%
0/283 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
|
Surgical and medical procedures
ABORTION INDUCED
|
1.1%
1/93 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
1.1%
3/283 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
Other adverse events
| Measure |
Placebo
n=93 participants at risk
Placebo was administered as bilateral intramuscular injections into the masseter on Day 1
|
BOTOX®
n=283 participants at risk
BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments
|
|---|---|---|
|
Infections and infestations
NASOPHARYNGITIS
|
3.2%
3/93 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
6.0%
17/283 • Number of events 19 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
6.5%
6/93 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
6.4%
18/283 • Number of events 22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
|
Musculoskeletal and connective tissue disorders
MASTICATION DISORDER
|
6.5%
6/93 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
4.9%
14/283 • Number of events 17 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
|
Nervous system disorders
HEADACHE
|
6.5%
6/93 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
3.9%
11/283 • Number of events 13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place