Trial Outcomes & Findings for A Study of MK-8189 in Participants With Schizophrenia (MK-8189-014) (NCT NCT05406440)
NCT ID: NCT05406440
Last Updated: 2024-07-25
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced one or more AEs were reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
53 participants
Primary outcome timeframe
Up to approximately 17 days
Results posted on
2024-07-25
Participant Flow
Fifty-three schizophrenia participants randomized to either MK-8189 or placebo in Panels A, A-1, and C. MK-8189 dose and schedule were modified for participants based on saftey and tolerability.
Participant milestones
| Measure |
Panel A MK-8189 48-60 mg
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD starting on Day 1 and 60 mg QD on Day 2.
|
Panel A Placebo
Participants with Schizophrenia received MK-8189-matching placebo oral dose of 0 mg QD on Day 1 and Day 2.
|
Panel A-1 MK-8189 48-80 mg
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD starting on Day 1 and 80 mg QD on Day 2.
|
Panel A-1 Placebo
Participants with Schizophrenia received MK-8189-matching placebo oral dose of 0 mg QD on Day 1 and Day 2.
|
Panel C MK-8189 48-80 mg
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD on Days 1-2 and 80 mg QD on Day 3 based on participant safety and tolerability.
|
Panel C MK-8189 48 mg
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD on Days 1-2.
|
Panel C Placebo
Participants with Schizophrenia received MK-8189-matching placebo oral dose of 0 mg QD Days 1-3.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
3
|
8
|
2
|
18
|
2
|
12
|
|
Overall Study
COMPLETED
|
8
|
3
|
8
|
2
|
15
|
0
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
3
|
2
|
0
|
Reasons for withdrawal
| Measure |
Panel A MK-8189 48-60 mg
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD starting on Day 1 and 60 mg QD on Day 2.
|
Panel A Placebo
Participants with Schizophrenia received MK-8189-matching placebo oral dose of 0 mg QD on Day 1 and Day 2.
|
Panel A-1 MK-8189 48-80 mg
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD starting on Day 1 and 80 mg QD on Day 2.
|
Panel A-1 Placebo
Participants with Schizophrenia received MK-8189-matching placebo oral dose of 0 mg QD on Day 1 and Day 2.
|
Panel C MK-8189 48-80 mg
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD on Days 1-2 and 80 mg QD on Day 3 based on participant safety and tolerability.
|
Panel C MK-8189 48 mg
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD on Days 1-2.
|
Panel C Placebo
Participants with Schizophrenia received MK-8189-matching placebo oral dose of 0 mg QD Days 1-3.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
A Study of MK-8189 in Participants With Schizophrenia (MK-8189-014)
Baseline characteristics by cohort
| Measure |
Panel A MK-8189 48-60 mg
n=8 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD starting on Day 1 and 60 mg QD on Day 2.
|
Panel A Placebo
n=3 Participants
Participants with Schizophrenia received MK-8189-matching placebo oral dose of 0 mg QD on Day 1 and Day 2.
|
Panel A-1 MK-8189 48-80 mg
n=8 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD starting on Day 1 and 80 mg QD on Day 2.
|
Panel A-1 Placebo
n=2 Participants
Participants with Schizophrenia received MK-8189-matching placebo oral dose of 0 mg QD on Day 1 and Day 2.
|
Panel C MK-8189 48-80 mg
n=18 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD on Days 1-2 and 80 mg QD on Day 3 based on participant safety and tolerability.
|
Panel C MK-8189 48 mg
n=2 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD on Days 1-2.
|
Panel C Placebo
n=12 Participants
Participants with Schizophrenia received MK-8189-matching placebo oral dose of 0 mg QD Days 1-3.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.1 Years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
42.0 Years
STANDARD_DEVIATION 4.0 • n=7 Participants
|
47.5 Years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
36.0 Years
STANDARD_DEVIATION 4.2 • n=4 Participants
|
42.4 Years
STANDARD_DEVIATION 8.1 • n=21 Participants
|
47.0 Years
STANDARD_DEVIATION 0.0 • n=10 Participants
|
46.1 Years
STANDARD_DEVIATION 8.1 • n=115 Participants
|
44.6 Years
STANDARD_DEVIATION 8.3 • n=6 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
20 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
33 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
8 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
45 Participants
n=6 Participants
|
|
Ethnicity (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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
39 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
7 Participants
n=6 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
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 17 daysPopulation: All participants who received as least one dose of the investigational drug. Per protocol, safety was assessed by dose.
An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced one or more AEs were reported.
Outcome measures
| Measure |
Panel A MK-8189 48 mg
n=8 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD on Day 1.
|
Panel A MK-8189 60mg
n=8 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 80 mg QD on Day 2.
|
Panel A Placebo
n=3 Participants
Participants with Schizophrenia received MK-8189-matching placebo oral dose of 0 mg QD on Day 1 and Day 2.
|
Panel A-1 MK-8189 48 mg
n=8 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD starting on Day 1.
|
Panel A-1 MK-8189 80 mg
n=8 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 80 mg QD on Day 2.
|
Panel A-1 Placebo
n=2 Participants
Participants with Schizophrenia received MK-8189-matching placebo oral dose of 0 mg QD on Day 1 and Day 2.
|
Panel C MK-8189 48 mg
n=20 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD on Days 1-2 based on participant safety and tolerability.
|
Panel C MK-8189 80 mg
n=18 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 80 mg QD on Day 3 based on participant safety and tolerability.
|
Panel C Placebo
n=12 Participants
Participants with Schizophrenia received MK-8189-matching placebo oral dose of 0 mg QD Days 1-3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing an Adverse Event (AE)
|
3 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 3 daysPopulation: All participants who received as least one dose of the investigational drug. Per protocol, safety was assessed by dose.
An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study due to an AE were reported.
Outcome measures
| Measure |
Panel A MK-8189 48 mg
n=8 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD on Day 1.
|
Panel A MK-8189 60mg
n=8 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 80 mg QD on Day 2.
|
Panel A Placebo
n=3 Participants
Participants with Schizophrenia received MK-8189-matching placebo oral dose of 0 mg QD on Day 1 and Day 2.
|
Panel A-1 MK-8189 48 mg
n=8 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD starting on Day 1.
|
Panel A-1 MK-8189 80 mg
n=8 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 80 mg QD on Day 2.
|
Panel A-1 Placebo
n=2 Participants
Participants with Schizophrenia received MK-8189-matching placebo oral dose of 0 mg QD on Day 1 and Day 2.
|
Panel C MK-8189 48 mg
n=20 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD on Days 1-2 based on participant safety and tolerability.
|
Panel C MK-8189 80 mg
n=18 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 80 mg QD on Day 3 based on participant safety and tolerability.
|
Panel C Placebo
n=12 Participants
Participants with Schizophrenia received MK-8189-matching placebo oral dose of 0 mg QD Days 1-3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinue From Study Treatment Due to an AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Panel A MK-8189 Dose 48 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Panel A MK-8189 60mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Panel A Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Panel A-1 MK-8189 48 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Panel A-1 MK-8189 80 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Panel A-1 Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Panel C MK-8189 48 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Panel C MK-8189 80 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Panel C Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Panel A MK-8189 Dose 48 mg
n=8 participants at risk
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD on Day 1.
|
Panel A MK-8189 60mg
n=8 participants at risk
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 80 mg QD on Day 2.
|
Panel A Placebo
n=3 participants at risk
Participants with Schizophrenia received MK-8189-matching placebo oral dose of 0 mg QD on Day 1 and Day 2.
|
Panel A-1 MK-8189 48 mg
n=8 participants at risk
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD starting on Day 1.
|
Panel A-1 MK-8189 80 mg
n=8 participants at risk
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 80 mg QD on Day 2.
|
Panel A-1 Placebo
n=2 participants at risk
Participants with Schizophrenia received MK-8189-matching placebo oral dose of 0 mg QD on Day 1 and Day 2.
|
Panel C MK-8189 48 mg
n=20 participants at risk
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD on Days 1-2 based on participant safety and tolerability.
|
Panel C MK-8189 80 mg
n=18 participants at risk
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 80 mg QD on Day 3 based on participant safety and tolerability.
|
Panel C Placebo
n=12 participants at risk
Participants with Schizophrenia received MK-8189-matching placebo oral dose of 0 mg QD Days 1-3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/20 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
8.3%
1/12 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/20 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
5.6%
1/18 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Eye disorders
Miosis
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/20 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
5.6%
1/18 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
8.3%
1/12 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
12.5%
1/8 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
5.0%
1/20 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/20 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
8.3%
1/12 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
12.5%
1/8 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
5.0%
1/20 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
5.0%
1/20 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
General disorders
Asthenia
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
12.5%
1/8 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
5.0%
1/20 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
General disorders
Discomfort
|
12.5%
1/8 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/20 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
General disorders
Fatigue
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
5.0%
1/20 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
General disorders
Feeling jittery
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
12.5%
1/8 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/20 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Investigations
Liver function test increased
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/20 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
5.6%
1/18 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
5.0%
1/20 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
12.5%
1/8 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/20 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/20 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
8.3%
1/12 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
5.0%
1/20 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/20 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
5.6%
1/18 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/20 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
8.3%
1/12 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Nervous system disorders
Akathisia
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
12.5%
1/8 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/20 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
10.0%
2/20 • Number of events 2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Nervous system disorders
Dystonia
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
5.0%
1/20 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
12.5%
1/8 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/20 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
16.7%
3/18 • Number of events 3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
8.3%
1/12 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/20 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
5.6%
1/18 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
8.3%
1/12 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Nervous system disorders
Oromandibular dystonia
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
5.0%
1/20 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Nervous system disorders
Parosmia
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
5.0%
1/20 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Nervous system disorders
Somnolence
|
12.5%
1/8 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
37.5%
3/8 • Number of events 3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
12.5%
1/8 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
5.0%
1/20 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
8.3%
1/12 • Number of events 2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Nervous system disorders
Tremor
|
12.5%
1/8 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/20 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Psychiatric disorders
Agitation
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/20 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
8.3%
1/12 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
12.5%
1/8 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/20 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
5.6%
1/18 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
12.5%
1/8 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/20 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
12.5%
1/8 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/20 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/20 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
5.6%
1/18 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
|
Social circumstances
Substance use
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
12.5%
1/8 • Number of events 1 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/3 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/8 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/2 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/20 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/18 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
0.00%
0/12 • Up to approximately 17 days
All participants who received at least one dose of treatment were included
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER