Trial Outcomes & Findings for A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1) (NCT NCT03537014)

Last Updated: 2025-06-06

Results Overview

The CAPS-5 is a 30-item semi-structured interview assessing PTSD in the past month through diagnostic and symptom severity scores anchored to a DSM-5 defined traumatic event. The CAPS-5 produces a Total Severity Score based on severity of PTSD domains described in the DSM-5, as well as a categorical rating indicating whether a participant meets PTSD diagnostic criteria. CAPS-5 Total Symptom Severity scores range from 0 to 80 with higher values indicating greater symptom severity. CAPS-5 assigns PTSD diagnosis as being present or absent.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

100 participants

Primary outcome timeframe

Baseline to 18 weeks post enrollment confirmation

Results posted on

2025-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	MDMA-assisted Therapy Administration of 80 or 120 mg MDMA in combination with psychotherapy and a supplemental dose offered 1.5/2 hrs later of 40 or 60 mg MDMA respectively. Psychotherapy: Standardized non-directive psychotherapy performed by therapist team MDMA: Administration of 80 to 120 mg MDMA during three sessions of MDMA-assisted psychotherapy followed by a supplemental dose of 40 or 60 mg MDMA offered 1.5/2 hrs after the initial dose, respectively.	Placebo With Therapy Administration of inactive placebo in combination with psychotherapy Psychotherapy: Standardized non-directive psychotherapy performed by therapist team Placebo: Administration of placebo during three sessions of MDMA-assisted psychotherapy
Overall Study STARTED	46	45
Overall Study COMPLETED	42	37
Overall Study NOT COMPLETED	4	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MDMA-assisted Therapy n=46 Participants Administration of 80 or 120 mg MDMA in combination with psychotherapy and a supplemental dose offered 1.5/2 hrs later of 40 or 60 mg MDMA respectively. Psychotherapy: Standardized non-directive psychotherapy performed by therapist team MDMA: Administration of 80 to 120 mg MDMA during three sessions of MDMA-assisted psychotherapy followed by a supplemental dose of 40 or 60 mg MDMA offered 1.5/2 hrs after the initial dose, respectively.	Placebo With Therapy n=44 Participants Administration of inactive placebo in combination with psychotherapy Psychotherapy: Standardized non-directive psychotherapy performed by therapist team Placebo: Administration of placebo during three sessions of MDMA-assisted psychotherapy	Total n=90 Participants Total of all reporting groups
Age, Continuous	43.55 years STANDARD_DEVIATION 12.86 • n=99 Participants	38.19 years STANDARD_DEVIATION 10.36 • n=107 Participants	40.93 years STANDARD_DEVIATION 11.95 • n=206 Participants
Sex: Female, Male Female	27 Participants n=99 Participants	32 Participants n=107 Participants	59 Participants n=206 Participants
Sex: Female, Male Male	19 Participants n=99 Participants	12 Participants n=107 Participants	31 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=99 Participants	3 Participants n=107 Participants	8 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=99 Participants	40 Participants n=107 Participants	81 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=99 Participants	0 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants	5 Participants n=107 Participants	7 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) White	39 Participants n=99 Participants	30 Participants n=107 Participants	69 Participants n=206 Participants
Race (NIH/OMB) More than one race	2 Participants n=99 Participants	6 Participants n=107 Participants	8 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Body mass index	26.0 kg/m^2 STANDARD_DEVIATION 4.8 • n=99 Participants	24.8 kg/m^2 STANDARD_DEVIATION 4.2 • n=107 Participants	25.4 kg/m^2 STANDARD_DEVIATION 4.5 • n=206 Participants
Duration of PTSD	14.8 years STANDARD_DEVIATION 11.6 • n=99 Participants	13.3 years STANDARD_DEVIATION 11.4 • n=107 Participants	14.0 years STANDARD_DEVIATION 11.5 • n=206 Participants
Dissociative subtype of PTSD	6 Participants n=99 Participants	13 Participants n=107 Participants	19 Participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline to 18 weeks post enrollment confirmation

Population: Modified intention-to-treat

Outcome measures

Outcome measures
Measure	MDMA-assisted Therapy n=46 Participants Administration of 80 or 120 mg midomafetamine HCl in combination with psychotherapy and a supplemental dose offered 1.5/2 hrs later of 40 or 60 mg respectively.	Placebo With Therapy n=44 Participants Administration of inactive placebo in combination with psychotherapy Psychotherapy: Standardized non-directive psychotherapy performed by therapist team Placebo: Administration of placebo during three sessions of MDMA-assisted psychotherapy
Change From Baseline to Primary Endpoint in Clinician Administered PTSD Scale for DSM-V (CAPS-5)	-24.5 score on a scale Interval -28.28 to -20.71	-12.64 score on a scale Interval -16.61 to -8.66

SECONDARY outcome

Timeframe: Baseline to 18 weeks post enrollment confirmation

Population: Modified intention-to-treat

The Sheehan Disability Scale (SDS) is a clinician-rated assessment of functional impairment that was adapted for the purposes of this study to limit missing item-level data as per the FDA requirements and included use of the three-item mean as the total score and imputation of work-related impairment. The SDS is a 3-item scale measuring the severity of disability in the domains of work, family life/home responsibilities and social/leisure activities, with each item scored on a ten-point Likert scale from 0 ('not at all impaired') to 10 ('very severely impaired'). The SDS total score was the mean of the 3 item responses. The SDS total score ranged from 0 to 10, with higher scores indicating greater functional impairment.

Outcome measures

Outcome measures
Measure	MDMA-assisted Therapy n=46 Participants Administration of 80 or 120 mg midomafetamine HCl in combination with psychotherapy and a supplemental dose offered 1.5/2 hrs later of 40 or 60 mg respectively.	Placebo With Therapy n=44 Participants Administration of inactive placebo in combination with psychotherapy Psychotherapy: Standardized non-directive psychotherapy performed by therapist team Placebo: Administration of placebo during three sessions of MDMA-assisted psychotherapy
Change From Baseline to Primary Endpoint in Sheehan Disability Scale (SDS) Total Score	-3.15 score on a scale Interval -3.9 to -2.4	-1.79 score on a scale Interval -2.58 to -1.0

Adverse Events

MDMA-assisted Therapy

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Placebo With Therapy

Serious events: 2 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MDMA-assisted Therapy n=46 participants at risk Administration of 80 or 120 mg midomafetamine HCl in combination with manualized psychotherapy and a supplemental dose offered 1.5/2 hrs later of 40 or 60 mg respectively.	Placebo With Therapy n=44 participants at risk Administration of inactive placebo in combination with manualized psychotherapy
Psychiatric disorders Suicide Attempt	0.00% 0/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	2.3% 1/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Psychiatric disorders Suicidal Ideation	0.00% 0/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	2.3% 1/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)

Other adverse events

Additional Information

Study Director

Lykos Therapeutics

Phone: 877-627-7722

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	MDMA-assisted Therapy n=46 participants at risk Administration of 80 or 120 mg midomafetamine HCl in combination with manualized psychotherapy and a supplemental dose offered 1.5/2 hrs later of 40 or 60 mg respectively.	Placebo With Therapy n=44 participants at risk Administration of inactive placebo in combination with manualized psychotherapy
Cardiac disorders Palpitations	8.7% 4/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	13.6% 6/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Eye disorders Mydriasis	15.2% 7/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	0.00% 0/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Eye disorders Vision Blurred	8.7% 4/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	2.3% 1/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Gastrointestinal disorders Abdominal Discomfort	13.0% 6/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	6.8% 3/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Gastrointestinal disorders Abdominal Pain Upper	10.9% 5/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	9.1% 4/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Gastrointestinal disorders Diarrhea	4.3% 2/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	11.4% 5/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Gastrointestinal disorders Dry Mouth	10.9% 5/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	4.5% 2/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Gastrointestinal disorders Nausea	30.4% 14/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	11.4% 5/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Gastrointestinal disorders Vomiting	8.7% 4/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	0.00% 0/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
General disorders Asthenia	10.9% 5/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	6.8% 3/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
General disorders Chills	6.5% 3/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	0.00% 0/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
General disorders Crying	0.00% 0/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	6.8% 3/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
General disorders Fatigue	30.4% 14/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	31.8% 14/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
General disorders Feeling Cold	19.6% 9/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	6.8% 3/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
General disorders Feeling Hot	8.7% 4/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	9.1% 4/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
General disorders Feeling Jittery	10.9% 5/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	0.00% 0/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
General disorders Influenza Like Illness	4.3% 2/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	6.8% 3/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
General disorders Non-Cardiac Chest Pain	8.7% 4/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	2.3% 1/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
General disorders Pain	8.7% 4/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	2.3% 1/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
General disorders Pyrexia	6.5% 3/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	2.3% 1/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
General disorders Temperature Intolerence	8.7% 4/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	4.5% 2/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Infections and infestations Upper Respiratory Tract Infection	10.9% 5/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	9.1% 4/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Investigations Blood Pressure Increased	10.9% 5/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	0.00% 0/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Metabolism and nutrition disorders Decreased Appetite	52.2% 24/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	11.4% 5/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Musculoskeletal and connective tissue disorders Arthralgia	8.7% 4/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	6.8% 3/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Musculoskeletal and connective tissue disorders Back Pain	10.9% 5/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	9.1% 4/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Musculoskeletal and connective tissue disorders Muscle Tightness	60.9% 28/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	13.6% 6/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Musculoskeletal and connective tissue disorders Muscle Twitching	6.5% 3/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	0.00% 0/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	8.7% 4/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	2.3% 1/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Musculoskeletal and connective tissue disorders Neck Pain	4.3% 2/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	9.1% 4/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Musculoskeletal and connective tissue disorders Pain in Jaw	6.5% 3/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	6.8% 3/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Nervous system disorders Disturbance in Attention	8.7% 4/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	6.8% 3/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Nervous system disorders Dizziness	19.6% 9/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	11.4% 5/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Nervous system disorders Dizziness Postural	13.0% 6/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	4.5% 2/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Nervous system disorders Headache	71.7% 33/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	54.5% 24/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Nervous system disorders Hypoaesthesia	6.5% 3/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	4.5% 2/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Nervous system disorders Nystagmus	13.0% 6/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	0.00% 0/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Nervous system disorders Paraesthesia	10.9% 5/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	6.8% 3/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Nervous system disorders Somnolence	6.5% 3/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	0.00% 0/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Nervous system disorders Tremor	10.9% 5/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	6.8% 3/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Psychiatric disorders Agitation	4.3% 2/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	6.8% 3/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Psychiatric disorders Anger	6.5% 3/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	13.6% 6/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Psychiatric disorders Anxiety	32.6% 15/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	38.6% 17/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Psychiatric disorders Bruxism	13.0% 6/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	2.3% 1/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Psychiatric disorders Depressed Mood	10.9% 5/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	9.1% 4/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Psychiatric disorders Depression	8.7% 4/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	9.1% 4/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Psychiatric disorders Emotional Disorder	4.3% 2/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	9.1% 4/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Psychiatric disorders Flashback	6.5% 3/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	4.5% 2/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Psychiatric disorders Insomnia	43.5% 20/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	29.5% 13/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Psychiatric disorders Intentional Self-Injury	2.2% 1/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	9.1% 4/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Psychiatric disorders Intrusive Thoughts	8.7% 4/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	0.00% 0/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Psychiatric disorders Irritability	4.3% 2/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	11.4% 5/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Psychiatric disorders Nervousness	6.5% 3/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	0.00% 0/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Psychiatric disorders Nightmare	15.2% 7/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	15.9% 7/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Psychiatric disorders Restlessness	15.2% 7/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	0.00% 0/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Psychiatric disorders Stress	8.7% 4/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	0.00% 0/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Psychiatric disorders Suicidal Ideation	45.7% 21/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	47.7% 21/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Renal and urinary disorders Micturition Urgency	6.5% 3/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	0.00% 0/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Renal and urinary disorders Pollakiuria	8.7% 4/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	2.3% 1/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	4.3% 2/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	6.8% 3/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Skin and subcutaneous tissue disorders Hyperhidrosis	21.7% 10/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	2.3% 1/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Social circumstances Substance Use	6.5% 3/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	0.00% 0/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Infections and infestations Nasopharyngitis	17.4% 8/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	13.6% 6/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)
Psychiatric disorders Panic Reaction	0.00% 0/46 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)	11.4% 5/44 • During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)