Trial Outcomes & Findings for Safety and Effectiveness of EN3835 in the Treatment of EFP in Women (NCT NCT03329989)
NCT ID: NCT03329989
Last Updated: 2020-12-29
Results Overview
Percentage of responders defined as participants with an improvement in cellulite severity from baseline of at least 2-levels of severity of at least one buttock (left or right) on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) with ratings ranging from "0" (None) to "4" (Severe). A 2-level responder is a participant with a reduction in severity of at least 2-levels from Baseline at that particular visit. Number of participants analyzed is determined by observed participants at each visit.
COMPLETED
PHASE2
158 participants
Day 22, 43, 90, and 180
2020-12-29
Participant Flow
Participant milestones
| Measure |
Collagenase Clostridium Histolyticum (CCH)
12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
|
|---|---|
|
Overall Study
STARTED
|
158
|
|
Overall Study
COMPLETED
|
135
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
Collagenase Clostridium Histolyticum (CCH)
12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Lost to Follow-up
|
8
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Safety and Effectiveness of EN3835 in the Treatment of EFP in Women
Baseline characteristics by cohort
| Measure |
Collagenase Clostridium Histolyticum (CCH)
n=158 Participants
12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
|
|---|---|
|
Age, Continuous
|
44.8 years
STANDARD_DEVIATION 10.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
158 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
114 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
135 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
26.74 kg/m^2
STANDARD_DEVIATION 5.259 • n=5 Participants
|
|
Skin Category (Fitzpatrick Scale)
I (Pale White)
|
3 Participants
n=5 Participants
|
|
Skin Category (Fitzpatrick Scale)
II (Fair)
|
34 Participants
n=5 Participants
|
|
Skin Category (Fitzpatrick Scale)
III (Darker White)
|
53 Participants
n=5 Participants
|
|
Skin Category (Fitzpatrick Scale)
IV (Light Brown)
|
48 Participants
n=5 Participants
|
|
Skin Category (Fitzpatrick Scale)
V (Brown)
|
10 Participants
n=5 Participants
|
|
Skin Category (Fitzpatrick Scale)
VI (Dark Brown)
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 22, 43, 90, and 180Population: Effectiveness Population
Percentage of responders defined as participants with an improvement in cellulite severity from baseline of at least 2-levels of severity of at least one buttock (left or right) on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) with ratings ranging from "0" (None) to "4" (Severe). A 2-level responder is a participant with a reduction in severity of at least 2-levels from Baseline at that particular visit. Number of participants analyzed is determined by observed participants at each visit.
Outcome measures
| Measure |
Collagenase Clostridium Histolyticum (CCH)
n=144 Participants
12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
|
|---|---|
|
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders
At Least One of two areas (Left & Right): Day 22 · Yes
|
6 Participants
|
|
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders
At Least One of two areas (Left & Right): Day 22 · No
|
131 Participants
|
|
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders
At Least One of two areas (Left & Right): Day 43 · Yes
|
8 Participants
|
|
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders
At Least One of two areas (Left & Right): Day 43 · No
|
125 Participants
|
|
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders
At Least One of two areas (Left & Right): Day 90 · Yes
|
17 Participants
|
|
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders
At Least One of two areas (Left & Right): Day 90 · No
|
110 Participants
|
|
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders
At Least One of two areas (Left & Right): Day 180 · Yes
|
20 Participants
|
|
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders
At Least One of two areas (Left & Right): Day 180 · No
|
111 Participants
|
SECONDARY outcome
Timeframe: Day 22, 43, 90, and 180Population: Effectiveness Population
Percentage of responders defined as participants with an improvement in cellulite severity from baseline of at least 1-level of severity of at least one buttock (left or right) on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) with ratings ranging from "0" (None) to "4" (Severe). A 1-level responder is a participant with a reduction in severity of at least 1-level from Baseline at that particular visit. Percentages are based on the observed counts. Number of participants analyzed is determined by observed participants at each visit.
Outcome measures
| Measure |
Collagenase Clostridium Histolyticum (CCH)
n=144 Participants
12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
|
|---|---|
|
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders
At Least One of Two Areas (Left & Right): Day 22 · Yes
|
55 Participants
|
|
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders
At Least One of Two Areas (Left & Right): Day 22 · No
|
82 Participants
|
|
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders
At Least One of Two Areas (Left & Right): Day 43 · Yes
|
87 Participants
|
|
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders
At Least One of Two Areas (Left & Right): Day 43 · No
|
46 Participants
|
|
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders
At Least One of Two Areas (Left & Right): Day 90 · Yes
|
96 Participants
|
|
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders
At Least One of Two Areas (Left & Right): Day 90 · No
|
31 Participants
|
|
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders
At Least One of Two Areas (Left & Right): Day 180 · Yes
|
90 Participants
|
|
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders
At Least One of Two Areas (Left & Right): Day 180 · No
|
41 Participants
|
SECONDARY outcome
Timeframe: Day 180Population: Overall number of participants analyzed is the number participants in effectiveness population at Day 180.
At Day 180, participants rated their satisfaction with cellulite treatment using the 5-point subject satisfaction scale. Ratings range from Very Satisfied with Treatment (2), Satisfied with Treatment (1), Neither Dissatisfied nor Satisfied with Treatment (0), Dissatisfied with Treatment (-1), and Very Dissatisfied with Treatment (-2). Percentages are based on the observed counts.
Outcome measures
| Measure |
Collagenase Clostridium Histolyticum (CCH)
n=130 Participants
12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
|
|---|---|
|
Subject Satisfaction With Cellulite Treatment Assessment at End of Study
Very Satisfied with Treatment (2)
|
25 Participants
|
|
Subject Satisfaction With Cellulite Treatment Assessment at End of Study
Satisfied with Treatment (1)
|
48 Participants
|
|
Subject Satisfaction With Cellulite Treatment Assessment at End of Study
Neither Dissatisfied nor Satisfied with Treatment
|
32 Participants
|
|
Subject Satisfaction With Cellulite Treatment Assessment at End of Study
Dissatisfied with Treatment (-1)
|
12 Participants
|
|
Subject Satisfaction With Cellulite Treatment Assessment at End of Study
Very Dissatisfied with Treatment (-2)
|
13 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Day 180Population: Safety Population
Percent of participants that are seropositive. Descriptive statistics were based on log10 transformation of titer levels. Percentages were based on the number of subjects who had immunogenicity lab samples drawn at the visit. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.
Outcome measures
| Measure |
Collagenase Clostridium Histolyticum (CCH)
n=158 Participants
12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
|
|---|---|
|
Overall Anti-AUX-I Serum Antibody by Visit
Anti-AUX-I: Day 1 · Seropositive
|
4 Participants
|
|
Overall Anti-AUX-I Serum Antibody by Visit
Anti-AUX-I: Day 1 · Seronegative
|
152 Participants
|
|
Overall Anti-AUX-I Serum Antibody by Visit
Anti-AUX-I: Day 22 · Seropositive
|
104 Participants
|
|
Overall Anti-AUX-I Serum Antibody by Visit
Anti-AUX-I: Day 22 · Seronegative
|
43 Participants
|
|
Overall Anti-AUX-I Serum Antibody by Visit
Anti-AUX-I: Day 43 · Seropositive
|
141 Participants
|
|
Overall Anti-AUX-I Serum Antibody by Visit
Anti-AUX-I: Day 43 · Seronegative
|
2 Participants
|
|
Overall Anti-AUX-I Serum Antibody by Visit
Anti-AUX-I: Day 90 · Seropositive
|
134 Participants
|
|
Overall Anti-AUX-I Serum Antibody by Visit
Anti-AUX-I: Day 90 · Seronegative
|
0 Participants
|
|
Overall Anti-AUX-I Serum Antibody by Visit
Anti-AUX-I: Day 180 · Seropositive
|
134 Participants
|
|
Overall Anti-AUX-I Serum Antibody by Visit
Anti-AUX-I: Day 180 · Seronegative
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Day 180Population: Safety Population
Descriptive statistics were based on log10 transformation of titer levels. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.
Outcome measures
| Measure |
Collagenase Clostridium Histolyticum (CCH)
n=158 Participants
12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
|
|---|---|
|
Overall Anti-AUX-I Antibody Log Titer Levels by Visit
Anti-AUX-I: Day 1 positive
|
2.046 log 10 titer
Standard Deviation 1.012
|
|
Overall Anti-AUX-I Antibody Log Titer Levels by Visit
Anti-AUX-I: Day 22 positive
|
2.268 log 10 titer
Standard Deviation 1.076
|
|
Overall Anti-AUX-I Antibody Log Titer Levels by Visit
Anti-AUX-I: Day 43 positive
|
4.681 log 10 titer
Standard Deviation 0.924
|
|
Overall Anti-AUX-I Antibody Log Titer Levels by Visit
Anti-AUX-I: Day 90 positive
|
5.937 log 10 titer
Standard Deviation 0.686
|
|
Overall Anti-AUX-I Antibody Log Titer Levels by Visit
Anti-AUX-I: Day 180 positive
|
5.556 log 10 titer
Standard Deviation 0.981
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Day 180Population: Safety Population
Percent of participants that are seropositive. Descriptive statistics were based on log10 transformation of titer levels. Percentages were based on the number of subjects who had immunogenicity lab samples drawn at the visit. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.
Outcome measures
| Measure |
Collagenase Clostridium Histolyticum (CCH)
n=158 Participants
12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
|
|---|---|
|
Overall Anti-AUX-II Serum Antibody by Visit
Anti-AUX-I: Day 1 · Seropositive
|
6 Participants
|
|
Overall Anti-AUX-II Serum Antibody by Visit
Anti-AUX-I: Day 1 · Seronegative
|
150 Participants
|
|
Overall Anti-AUX-II Serum Antibody by Visit
Anti-AUX-I: Day 22 · Seropositive
|
50 Participants
|
|
Overall Anti-AUX-II Serum Antibody by Visit
Anti-AUX-I: Day 22 · Seronegative
|
98 Participants
|
|
Overall Anti-AUX-II Serum Antibody by Visit
Anti-AUX-I: Day 43 · Seropositive
|
138 Participants
|
|
Overall Anti-AUX-II Serum Antibody by Visit
Anti-AUX-I: Day 43 · Seronegative
|
5 Participants
|
|
Overall Anti-AUX-II Serum Antibody by Visit
Anti-AUX-I: Day 90 · Seropositive
|
131 Participants
|
|
Overall Anti-AUX-II Serum Antibody by Visit
Anti-AUX-I: Day 90 · Seronegative
|
0 Participants
|
|
Overall Anti-AUX-II Serum Antibody by Visit
Anti-AUX-I: Day 180 · Seropositive
|
130 Participants
|
|
Overall Anti-AUX-II Serum Antibody by Visit
Anti-AUX-I: Day 180 · Seronegative
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Day 180Population: Safety Population
Descriptive statistics were based on log10 transformation of titer levels. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.
Outcome measures
| Measure |
Collagenase Clostridium Histolyticum (CCH)
n=158 Participants
12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
|
|---|---|
|
Overall Anti-AUX-II Antibody Log Titer Levels by Visit
Anti-AUX-II: Day 1 positive
|
1.607 log 10 titer
Standard Deviation 0.947
|
|
Overall Anti-AUX-II Antibody Log Titer Levels by Visit
Anti-AUX-II: Day 22 positive
|
1.942 log 10 titer
Standard Deviation 1.068
|
|
Overall Anti-AUX-II Antibody Log Titer Levels by Visit
Anti-AUX-II: Day 43 positive
|
3.641 log 10 titer
Standard Deviation 1.068
|
|
Overall Anti-AUX-II Antibody Log Titer Levels by Visit
Anti-AUX-II: Day 90 positive
|
5.255 log 10 titer
Standard Deviation 0.809
|
|
Overall Anti-AUX-II Antibody Log Titer Levels by Visit
Anti-AUX-II: Day 180 positive
|
5.141 log 10 titer
Standard Deviation 0.913
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Day 180Population: Safety Population
A subset of all CCH Treated participants who had positive binding antibody titer levels were tested for the presence or absence of Neutralizing Antibodies. Overall Number of Participants Analyzed is determined by the number of participants in the highest and lowest quartiles at Day 90 (Q1 and Q4) of seropositive participants at each of two visits (Day 90 and Day 180).
Outcome measures
| Measure |
Collagenase Clostridium Histolyticum (CCH)
n=34 Participants
12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
|
|---|---|
|
Anti-AUX-I Neutralizing Antibodies by Visit
anti-AUX-I Neutralizing Antibody: Day 1 · Positive
|
0 Participants
|
|
Anti-AUX-I Neutralizing Antibodies by Visit
anti-AUX-I Neutralizing Antibody: Day 1 · Negative
|
1 Participants
|
|
Anti-AUX-I Neutralizing Antibodies by Visit
anti-AUX-I Neutralizing Antibody: Day 90 · Positive
|
26 Participants
|
|
Anti-AUX-I Neutralizing Antibodies by Visit
anti-AUX-I Neutralizing Antibody: Day 90 · Negative
|
8 Participants
|
|
Anti-AUX-I Neutralizing Antibodies by Visit
anti-AUX-I Neutralizing Antibody: Day 180 · Positive
|
19 Participants
|
|
Anti-AUX-I Neutralizing Antibodies by Visit
anti-AUX-I Neutralizing Antibody: Day 180 · Negative
|
14 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Day 180Population: Safety Population
A subset of all CCH Treated participants who had positive binding antibody titer levels were tested for the presence or absence of Neutralizing Antibodies. Overall Number of Participants Analyzed is determined by the number of participants in the study. Number of Participants Analyzed is determined by observed participants that had a seropositive sample at each visit and the antibody level at Day 71 in Q1 and Q4.
Outcome measures
| Measure |
Collagenase Clostridium Histolyticum (CCH)
n=32 Participants
12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
|
|---|---|
|
Anti-AUX-II Neutralizing Antibodies by Visit
anti-AUX-II Neutralizing Antibodies: Day 1 · Positive
|
1 Participants
|
|
Anti-AUX-II Neutralizing Antibodies by Visit
anti-AUX-II Neutralizing Antibodies: Day 1 · Negative
|
0 Participants
|
|
Anti-AUX-II Neutralizing Antibodies by Visit
anti-AUX-II Neutralizing Antibodies: Day 90 · Positive
|
24 Participants
|
|
Anti-AUX-II Neutralizing Antibodies by Visit
anti-AUX-II Neutralizing Antibodies: Day 90 · Negative
|
8 Participants
|
|
Anti-AUX-II Neutralizing Antibodies by Visit
anti-AUX-II Neutralizing Antibodies: Day 180 · Positive
|
20 Participants
|
|
Anti-AUX-II Neutralizing Antibodies by Visit
anti-AUX-II Neutralizing Antibodies: Day 180 · Negative
|
11 Participants
|
Adverse Events
Collagenase Clostridium Histolyticum (CCH)
Serious adverse events
| Measure |
Collagenase Clostridium Histolyticum (CCH)
n=158 participants at risk
EN3835 0.84mg (Collagenase Clostridium Histolyticum)
Collagenase Clostridium Histolyticum: During 3 treatment visits 12 injections is given per treatment area
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.63%
1/158 • All (serious and non-serious) AEs, from Day 1 up to Day 180
All (serious and nonserious) AEs, whether elicited or observed during study visits or spontaneously reported by the participant, including events that occurred from the time the participant signed the study-specific consent form until completion of or discharge from the study.
|
Other adverse events
| Measure |
Collagenase Clostridium Histolyticum (CCH)
n=158 participants at risk
EN3835 0.84mg (Collagenase Clostridium Histolyticum)
Collagenase Clostridium Histolyticum: During 3 treatment visits 12 injections is given per treatment area
|
|---|---|
|
General disorders
Injection site bruising
|
86.1%
136/158 • All (serious and non-serious) AEs, from Day 1 up to Day 180
All (serious and nonserious) AEs, whether elicited or observed during study visits or spontaneously reported by the participant, including events that occurred from the time the participant signed the study-specific consent form until completion of or discharge from the study.
|
|
General disorders
Injection site pain
|
48.1%
76/158 • All (serious and non-serious) AEs, from Day 1 up to Day 180
All (serious and nonserious) AEs, whether elicited or observed during study visits or spontaneously reported by the participant, including events that occurred from the time the participant signed the study-specific consent form until completion of or discharge from the study.
|
|
General disorders
Injection site swelling
|
22.2%
35/158 • All (serious and non-serious) AEs, from Day 1 up to Day 180
All (serious and nonserious) AEs, whether elicited or observed during study visits or spontaneously reported by the participant, including events that occurred from the time the participant signed the study-specific consent form until completion of or discharge from the study.
|
|
General disorders
Injection site pruritus
|
17.1%
27/158 • All (serious and non-serious) AEs, from Day 1 up to Day 180
All (serious and nonserious) AEs, whether elicited or observed during study visits or spontaneously reported by the participant, including events that occurred from the time the participant signed the study-specific consent form until completion of or discharge from the study.
|
|
General disorders
Injection site discolouration
|
16.5%
26/158 • All (serious and non-serious) AEs, from Day 1 up to Day 180
All (serious and nonserious) AEs, whether elicited or observed during study visits or spontaneously reported by the participant, including events that occurred from the time the participant signed the study-specific consent form until completion of or discharge from the study.
|
|
General disorders
Injection site nodule
|
14.6%
23/158 • All (serious and non-serious) AEs, from Day 1 up to Day 180
All (serious and nonserious) AEs, whether elicited or observed during study visits or spontaneously reported by the participant, including events that occurred from the time the participant signed the study-specific consent form until completion of or discharge from the study.
|
|
General disorders
Injection site warmth
|
11.4%
18/158 • All (serious and non-serious) AEs, from Day 1 up to Day 180
All (serious and nonserious) AEs, whether elicited or observed during study visits or spontaneously reported by the participant, including events that occurred from the time the participant signed the study-specific consent form until completion of or discharge from the study.
|
|
General disorders
Injection site haemorrhage
|
10.8%
17/158 • All (serious and non-serious) AEs, from Day 1 up to Day 180
All (serious and nonserious) AEs, whether elicited or observed during study visits or spontaneously reported by the participant, including events that occurred from the time the participant signed the study-specific consent form until completion of or discharge from the study.
|
|
General disorders
Injection site mass
|
6.3%
10/158 • All (serious and non-serious) AEs, from Day 1 up to Day 180
All (serious and nonserious) AEs, whether elicited or observed during study visits or spontaneously reported by the participant, including events that occurred from the time the participant signed the study-specific consent form until completion of or discharge from the study.
|
|
Skin and subcutaneous tissue disorders
Hemosiderin stain
|
5.1%
8/158 • All (serious and non-serious) AEs, from Day 1 up to Day 180
All (serious and nonserious) AEs, whether elicited or observed during study visits or spontaneously reported by the participant, including events that occurred from the time the participant signed the study-specific consent form until completion of or discharge from the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place