Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia (NCT NCT01469039)
NCT ID: NCT01469039
Last Updated: 2019-01-30
Results Overview
The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
623 participants
Primary outcome timeframe
Data collected from baseline to day 85
Results posted on
2019-01-30
Participant Flow
Included subjects with schizophrenia experiencing an acute exacerbation episode.
Subjects were admitted to an inpatient study unit. Currently prescribed antipsychotics were discontinued prior to administration of study drug. One randomized subject was discontinued for a protocol violation prior to receiving investigational treatment.
Participant milestones
| Measure |
Aripiprazole Lauroxil 441 mg
Intramuscular injection, given monthly
|
Aripiprazole Lauroxil 882 mg
Intramuscular injection, given monthly
|
Placebo
Intramuscular injection, given monthly
|
|---|---|---|---|
|
Overall Study
STARTED
|
207
|
208
|
208
|
|
Overall Study
COMPLETED
|
130
|
135
|
95
|
|
Overall Study
NOT COMPLETED
|
77
|
73
|
113
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia
Baseline characteristics by cohort
| Measure |
Aripiprazole Lauroxil 441 mg
n=207 Participants
Intramuscular injection, given monthly
|
Aripiprazole Lauroxil 882 mg
n=208 Participants
Intramuscular injection, given monthly
|
Placebo
n=208 Participants
Intramuscular injection, given monthly
|
Total
n=623 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
205 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
618 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
39.9 Years
STANDARD_DEVIATION 10.13 • n=5 Participants
|
39.7 Years
STANDARD_DEVIATION 11.06 • n=7 Participants
|
39.5 Years
STANDARD_DEVIATION 11.85 • n=5 Participants
|
39.7 Years
STANDARD_DEVIATION 11.02 • n=4 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
141 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
423 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
83 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
248 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
99 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
291 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
103 participants
n=5 Participants
|
102 participants
n=7 Participants
|
102 participants
n=5 Participants
|
307 participants
n=4 Participants
|
|
Region of Enrollment
Philippines
|
16 participants
n=5 Participants
|
21 participants
n=7 Participants
|
16 participants
n=5 Participants
|
53 participants
n=4 Participants
|
|
Region of Enrollment
Malaysia
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Region of Enrollment
Ukraine
|
29 participants
n=5 Participants
|
29 participants
n=7 Participants
|
32 participants
n=5 Participants
|
90 participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
Region of Enrollment
Bulgaria
|
23 participants
n=5 Participants
|
19 participants
n=7 Participants
|
17 participants
n=5 Participants
|
59 participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
25 participants
n=5 Participants
|
73 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Data collected from baseline to day 85Population: Full Analysis Set (FAS) defined as all randomized subjects who received at least 1 dose of IM study drug and had at least 1 primary efficacy assessment after administration of IM study drug.
The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.
Outcome measures
| Measure |
Aripiprazole Lauroxil 441 mg
n=196 Participants
Intramuscular injection, given monthly
|
Aripiprazole Lauroxil 882 mg
n=204 Participants
Intramuscular injection, given monthly
|
Placebo
n=196 Participants
Intramuscular injection, given monthly
|
|---|---|---|---|
|
The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score
|
-20.9 units on a scale
Standard Error 1.39
|
-21.8 units on a scale
Standard Error 1.35
|
-9.8 units on a scale
Standard Error 1.39
|
SECONDARY outcome
Timeframe: 85 DaysPopulation: FAS, defined as all randomized subjects who received at least 1 IM dose of study drug and had at least 1 primary efficacy assessment after administration of IM study drug.
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the study. Results indicate participants evaluated at one of the following categories: "1: very much improved"; "2: much improved"; "3: minimally improved"; "4: no change"; "5: minimally worse"; "6: much worse"; or "7: very much worse".
Outcome measures
| Measure |
Aripiprazole Lauroxil 441 mg
n=196 Participants
Intramuscular injection, given monthly
|
Aripiprazole Lauroxil 882 mg
n=204 Participants
Intramuscular injection, given monthly
|
Placebo
n=196 Participants
Intramuscular injection, given monthly
|
|---|---|---|---|
|
Clinical Global Impression - Improvement (CGI-I) Scores at Day 85
CGI Score: Very much worse
|
1 participants in category
|
1 participants in category
|
3 participants in category
|
|
Clinical Global Impression - Improvement (CGI-I) Scores at Day 85
CGI Score: Very much improved
|
27 participants in category
|
25 participants in category
|
15 participants in category
|
|
Clinical Global Impression - Improvement (CGI-I) Scores at Day 85
CGI Score: Much improved
|
68 participants in category
|
81 participants in category
|
33 participants in category
|
|
Clinical Global Impression - Improvement (CGI-I) Scores at Day 85
GCI Score: Minimally improved
|
45 participants in category
|
52 participants in category
|
43 participants in category
|
|
Clinical Global Impression - Improvement (CGI-I) Scores at Day 85
CGI Score: No change
|
32 participants in category
|
24 participants in category
|
42 participants in category
|
|
Clinical Global Impression - Improvement (CGI-I) Scores at Day 85
CGI Score: Minimally worse
|
11 participants in category
|
16 participants in category
|
37 participants in category
|
|
Clinical Global Impression - Improvement (CGI-I) Scores at Day 85
CGI Score: Much worse
|
12 participants in category
|
5 participants in category
|
23 participants in category
|
Adverse Events
Aripiprazole Lauroxil 441 mg
Serious events: 3 serious events
Other events: 66 other events
Deaths: 0 deaths
Aripiprazole Lauroxil 882 mg
Serious events: 4 serious events
Other events: 68 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aripiprazole Lauroxil 441 mg
n=207 participants at risk
Intramuscular injection, given monthly
|
Aripiprazole Lauroxil 882 mg
n=208 participants at risk
Intramuscular injection, given monthly
|
Placebo
n=207 participants at risk
Intramuscular injection, given monthly
|
|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.48%
1/207 • Number of events 1 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
0.00%
0/208 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
0.00%
0/207 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
|
Gastrointestinal disorders
Peritoneal adhesions
|
0.48%
1/207 • Number of events 1 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
0.00%
0/208 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
0.00%
0/207 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
|
Infections and infestations
Appendicitis
|
0.48%
1/207 • Number of events 1 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
0.00%
0/208 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
0.00%
0/207 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/207 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
0.00%
0/208 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
0.48%
1/207 • Number of events 1 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/207 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
0.48%
1/208 • Number of events 1 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
0.00%
0/207 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/207 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
0.48%
1/208 • Number of events 1 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
0.00%
0/207 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
|
Psychiatric disorders
Drug Abuse
|
0.00%
0/207 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
0.48%
1/208 • Number of events 1 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
0.00%
0/207 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/207 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
0.00%
0/208 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
0.48%
1/207 • Number of events 1 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/207 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
0.00%
0/208 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
0.48%
1/207 • Number of events 1 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/207 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
0.48%
1/208 • Number of events 1 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
0.00%
0/207 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
|
Social circumstances
Victim of homicide
|
0.00%
0/207 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
0.00%
0/208 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
0.48%
1/207 • Number of events 1 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
Other adverse events
| Measure |
Aripiprazole Lauroxil 441 mg
n=207 participants at risk
Intramuscular injection, given monthly
|
Aripiprazole Lauroxil 882 mg
n=208 participants at risk
Intramuscular injection, given monthly
|
Placebo
n=207 participants at risk
Intramuscular injection, given monthly
|
|---|---|---|---|
|
Nervous system disorders
Akathisia
|
11.6%
24/207 • Number of events 26 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
11.1%
23/208 • Number of events 30 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
4.3%
9/207 • Number of events 9 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
|
Nervous system disorders
Headache
|
8.2%
17/207 • Number of events 20 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
8.7%
18/208 • Number of events 22 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
8.2%
17/207 • Number of events 20 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
|
Psychiatric disorders
Agitation
|
1.4%
3/207 • Number of events 4 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
1.4%
3/208 • Number of events 3 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
5.3%
11/207 • Number of events 11 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
|
Psychiatric disorders
Anxiety
|
2.9%
6/207 • Number of events 11 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
5.3%
11/208 • Number of events 14 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
6.8%
14/207 • Number of events 16 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
|
Psychiatric disorders
Insomnia
|
9.7%
20/207 • Number of events 26 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
12.0%
25/208 • Number of events 27 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
11.6%
24/207 • Number of events 29 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
|
Psychiatric disorders
Schizophrenia
|
5.8%
12/207 • Number of events 13 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
2.4%
5/208 • Number of events 5 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
10.6%
22/207 • Number of events 22 • Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
|
Additional Information
ARISTADA Medical Information
Alkermes, Inc.
Phone: 866-274-7823
Results disclosure agreements
- Principal investigator is a sponsor employee Should an Investigator desire to disclose study results, Sponsor will review the results disclosure prior to public release and can embargo the disclosure for a period of at least 60 days. Revisions to the disclosure will be negotiated in good faith. For a multicenter study the Investigators agree to publish/publicly present the results together with the other sites for the 12 month period after study results are available unless Sponsor grants written permission in advance.
- Publication restrictions are in place
Restriction type: OTHER