Trial Outcomes & Findings for Mavoglurant in Alcohol Drinking (NCT NCT03327792)

Last Updated: 2024-08-06

Results Overview

Number of participants (at Day 10; after both alcohol sessions and completed course of mavoglurant) with abnormal lab values or adverse events related to the interaction of alcohol and mavoglurant

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

34 participants

Primary outcome timeframe

Day 10

Results posted on

2024-08-06

Participant Flow

34 Participants enrolled in the study, however there was an error in calculating alcohol dose in one participant. Analysis excluded this one participant, 33 analyzed at baseline. 24 completed study and had outcome data, excluding this 1 participant, the final analysis is n=23.

Participant milestones

Participant milestones
Measure	200 mg Mavoglurant 200 mg mavoglurant once daily for 7-10 days Mavoglurant: 200 mg Mavoglurant	Placebo Placebo once daily for 7-10 days Placebo: Placebo
Overall Study STARTED	17	17
Overall Study COMPLETED	10	14
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Reasons for withdrawal
Measure	200 mg Mavoglurant 200 mg mavoglurant once daily for 7-10 days Mavoglurant: 200 mg Mavoglurant	Placebo Placebo once daily for 7-10 days Placebo: Placebo
Overall Study Adverse Event	4	0
Overall Study Family/Personal issues	3	2
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Mavoglurant in Alcohol Drinking

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	200 mg Mavoglurant n=16 Participants 200 mg mavoglurant once daily for 7-10 days Mavoglurant: 200 mg Mavoglurant	Placebo n=17 Participants Placebo once daily for 7-10 days Placebo: Placebo	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	26.3 years STANDARD_DEVIATION 4.51 • n=5 Participants	29.1 years STANDARD_DEVIATION 6.68 • n=7 Participants	27.7 years STANDARD_DEVIATION 5.83 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Multi-Race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	17 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 10

Population: 34 Participants enrolled in the study, however there was an error in calculating alcohol dose in one participant. Analysis excluded this one participant, 33 analyzed at baseline. 24 completed study and had outcome data, excluding this 1 participant, the final analysis is n=23.

Number of participants (at Day 10; after both alcohol sessions and completed course of mavoglurant) with abnormal lab values or adverse events related to the interaction of alcohol and mavoglurant

Outcome measures

Outcome measures
Measure	200 mg Mavoglurant n=9 Participants 200 mg mavoglurant once daily for 7-10 days Mavoglurant: 200 mg Mavoglurant	Placebo n=14 Participants Placebo once daily for 7-10 days Placebo: Placebo
Abnormal Labs and Adverse Events Number of participants that reported Adverse Event(s)	9 Participants	8 Participants
Abnormal Labs and Adverse Events Abnormal/Clinically Significant lab values after Mavoglurant and alcohol administration	0 Participants	0 Participants

Adverse Events

200 mg Mavoglurant

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Suchitra Krishnan-Sarin

Yale University

Phone: 203-974-7595

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	200 mg Mavoglurant n=17 participants at risk 200 mg mavoglurant once daily for 7-10 days Mavoglurant: 200 mg Mavoglurant	Placebo n=17 participants at risk Placebo once daily for 7-10 days Placebo: Placebo
Nervous system disorders Lightheaded	17.6% 3/17 • Number of events 3 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Nervous system disorders Saw Scary Faces While Sleeping	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
General disorders Sinus Pressure	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Eye disorders Closer things looked closer; Farther things looked farther away	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Cardiac disorders Racing Heart	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Psychiatric disorders Mania/Hyperactivity	17.6% 3/17 • Number of events 3 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Nervous system disorders Dissociation	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Gastrointestinal disorders Appetite Change	23.5% 4/17 • Number of events 4 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Gastrointestinal disorders Acid Indigestion	5.9% 1/17 • Number of events 2 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Musculoskeletal and connective tissue disorders Sore Arm	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Musculoskeletal and connective tissue disorders Back Ache	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Nervous system disorders Dizziness	52.9% 9/17 • Number of events 10 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Nervous system disorders Confusion	11.8% 2/17 • Number of events 3 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Respiratory, thoracic and mediastinal disorders Congestion	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Gastrointestinal disorders Constipation	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	11.8% 2/17 • Number of events 2 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Respiratory, thoracic and mediastinal disorders Cough	11.8% 2/17 • Number of events 2 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Gastrointestinal disorders Diarrhea	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Nervous system disorders Extra sense of focus	11.8% 2/17 • Number of events 2 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Nervous system disorders Face Numbness	5.9% 1/17 • Number of events 2 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Nervous system disorders Fatigue	11.8% 2/17 • Number of events 2 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	17.6% 3/17 • Number of events 3 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Psychiatric disorders Feeling High/Intoxicated	17.6% 3/17 • Number of events 3 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Renal and urinary disorders Frequent Urination	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	5.9% 1/17 • Number of events 2 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Nervous system disorders Good Mood / Awake	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Nervous system disorders Headache	29.4% 5/17 • Number of events 6 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	11.8% 2/17 • Number of events 2 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Musculoskeletal and connective tissue disorders Hurt Ankle	5.9% 1/17 • Number of events 2 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Nervous system disorders Insomnia	35.3% 6/17 • Number of events 8 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	11.8% 2/17 • Number of events 4 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Psychiatric disorders Irritable	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Skin and subcutaneous tissue disorders Itchy	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Nervous system disorders Lack of Focus	23.5% 4/17 • Number of events 4 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Nervous system disorders Memory Loss	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Psychiatric disorders Mood Altered	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
General disorders Mouth and Throat Pain	5.9% 1/17 • Number of events 2 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Musculoskeletal and connective tissue disorders Moving/Walking Slower	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Musculoskeletal and connective tissue disorders Muscle Pain	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Musculoskeletal and connective tissue disorders Muscle Twitch	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Gastrointestinal disorders Nausea	35.3% 6/17 • Number of events 6 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	23.5% 4/17 • Number of events 5 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Psychiatric disorders Nervousness / Anxiety	35.3% 6/17 • Number of events 7 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Nervous system disorders Night Sweats	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Psychiatric disorders Nightmares	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Skin and subcutaneous tissue disorders Pimples/Face Swelling	5.9% 1/17 • Number of events 1 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).	0.00% 0/17 • Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks. Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).