Trial Outcomes & Findings for Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD (NCT NCT04784143)

Last Updated: 2025-07-15

Results Overview

The Clinician-Administered PTSD Scale for DSM-5 (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

TERMINATED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

2 Session Group: ~12 weeks from baseline to primary outcome; 3 Session Group: ~16 weeks from baseline to primary outcome

Results posted on

2025-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	Two Sessions of MDMA-assisted Therapy Two experimental sessions of MDMA-assisted therapy Midomafetamine: 120 mg midomafetamine HCl followed by a supplemental dose of 60 mg Psychotherapy: Manualized psychotherapy performed by therapist team	Three Sessions of MDMA-assisted Therapy Three experimental sessions of MDMA-assisted therapy Midomafetamine: 120 mg midomafetamine HCl followed by a supplemental dose of 60 mg Psychotherapy: Manualized psychotherapy performed by therapist team
Overall Study STARTED	13	10
Overall Study COMPLETED	12	8
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Two Sessions of MDMA-assisted Therapy n=13 Participants Two experimental sessions of MDMA-assisted therapy Midomafetamine: 120 mg midomafetamine HCl followed by a supplemental dose of 60 mg Psychotherapy: Manualized psychotherapy performed by therapist team	Three Sessions of MDMA-assisted Therapy n=10 Participants Three experimental sessions of MDMA-assisted therapy Midomafetamine: 120 mg midomafetamine HCl followed by a supplemental dose of 60 mg Psychotherapy: Manualized psychotherapy performed by therapist team	Total n=23 Participants Total of all reporting groups
Age, Continuous	41.6 years STANDARD_DEVIATION 6.23 • n=5 Participants	38.3 years STANDARD_DEVIATION 5.06 • n=7 Participants	40.2 years STANDARD_DEVIATION 5.87 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	10 participants n=7 Participants	23 participants n=5 Participants
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Score	37.1 score on a scale STANDARD_DEVIATION 6.38 • n=5 Participants	43.8 score on a scale STANDARD_DEVIATION 7.71 • n=7 Participants	40.0 score on a scale STANDARD_DEVIATION 7.63 • n=5 Participants

PRIMARY outcome

Timeframe: 2 Session Group: ~12 weeks from baseline to primary outcome; 3 Session Group: ~16 weeks from baseline to primary outcome

Population: One participant in the 3 session group did not complete the primary outcome assessment.

Outcome measures

Outcome measures
Measure	Two Sessions of MDMA-assisted Therapy n=13 Participants Two experimental sessions of MDMA-assisted therapy Midomafetamine: 120 mg midomafetamine HCl followed by a supplemental dose of 60 mg Psychotherapy: Manualized psychotherapy performed by therapist team	Three Sessions of MDMA-assisted Therapy n=9 Participants Three experimental sessions of MDMA-assisted therapy Midomafetamine: 120 mg midomafetamine HCl followed by a supplemental dose of 60 mg Psychotherapy: Manualized psychotherapy performed by therapist team
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score From Baseline to Primary Outcome	-20.5 score on a scale Standard Deviation 9.38	-18.0 score on a scale Standard Deviation 13.92

PRIMARY outcome

Timeframe: ~16 weeks from baseline to secondary outcome (note: secondary outcome timepoint assessed in 2 session group to evaluate the primary outcome measure in a follow up period equivalent to that of the 3 session group in the primary analysis.)

Population: One participant in the 2 session group did not complete the CAPS-5 at the secondary outcome timepoint.

Outcome measures

Outcome measures
Measure	Two Sessions of MDMA-assisted Therapy n=12 Participants Two experimental sessions of MDMA-assisted therapy Midomafetamine: 120 mg midomafetamine HCl followed by a supplemental dose of 60 mg Psychotherapy: Manualized psychotherapy performed by therapist team	Three Sessions of MDMA-assisted Therapy Three experimental sessions of MDMA-assisted therapy Midomafetamine: 120 mg midomafetamine HCl followed by a supplemental dose of 60 mg Psychotherapy: Manualized psychotherapy performed by therapist team
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score From Baseline to Secondary Outcome Timepoint in the 2 Session Group	-24.9 score on a scale Standard Deviation 8.73	—

SECONDARY outcome

Timeframe: 2 Session Group: ~12 weeks from baseline to primary outcome; 3 Session Group: ~16 weeks from baseline to primary outcome

Population: One participant in the 3 session group did not complete the secondary outcome assessment.

The Sheehan Disability Scale (SDS) is a clinician-rated assessment of functional 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'). SDS scoring was adapted for the purposes of this study to limit missing item-level data through averaging the three domain scores to produce a total score, as well as imputation of work-related impairment score in the case of participants who did not work during the reporting period based on the reason for not working. The SDS total score and each of the domain sub-scores range from 0 to 10, with higher scores indicating greater functional impairment.

Outcome measures

Outcome measures
Measure	Two Sessions of MDMA-assisted Therapy n=13 Participants Two experimental sessions of MDMA-assisted therapy Midomafetamine: 120 mg midomafetamine HCl followed by a supplemental dose of 60 mg Psychotherapy: Manualized psychotherapy performed by therapist team	Three Sessions of MDMA-assisted Therapy n=9 Participants Three experimental sessions of MDMA-assisted therapy Midomafetamine: 120 mg midomafetamine HCl followed by a supplemental dose of 60 mg Psychotherapy: Manualized psychotherapy performed by therapist team
Change in Sheehan Disability Scale (SDS) Total Score From Baseline to Primary Outcome	-2.9 score on a scale Standard Deviation 2.30	-1.6 score on a scale Standard Deviation 3.49

SECONDARY outcome

Population: One participant in the 2 session group did not complete the SDS at the secondary outcome timepoint.

Sheehan Disability Scale (SDS) total score, a measure of clinician-rated functional impairment. The items indicate degree of impairment in the domains of work/school, social life, and home life, with response options based on an eleven-point scale (0=not at all to 10=extremely), and five verbal tags (not at all, mildly, moderately, markedly, extremely).

Outcome measures

Outcome measures
Measure	Two Sessions of MDMA-assisted Therapy n=12 Participants Two experimental sessions of MDMA-assisted therapy Midomafetamine: 120 mg midomafetamine HCl followed by a supplemental dose of 60 mg Psychotherapy: Manualized psychotherapy performed by therapist team	Three Sessions of MDMA-assisted Therapy Three experimental sessions of MDMA-assisted therapy Midomafetamine: 120 mg midomafetamine HCl followed by a supplemental dose of 60 mg Psychotherapy: Manualized psychotherapy performed by therapist team
Change in Sheehan Disability Scale (SDS) Total Score From Baseline to Secondary Outcome Timepoint in the 2 Session Group	-4.1 score on a scale Standard Deviation 2.39	—

Adverse Events

Two Sessions of MDMA-assisted Therapy

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Three Sessions of MDMA-assisted Therapy

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

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

Other adverse events
Measure	Two Sessions of MDMA-assisted Therapy n=13 participants at risk Two experimental sessions of MDMA-assisted therapy Midomafetamine: 120 mg midomafetamine HCl followed by a supplemental dose of 60 mg Psychotherapy: Manualized psychotherapy performed by therapist team	Three Sessions of MDMA-assisted Therapy n=10 participants at risk Three experimental sessions of MDMA-assisted therapy Midomafetamine: 120 mg midomafetamine HCl followed by a supplemental dose of 60 mg Psychotherapy: Manualized psychotherapy performed by therapist team
Psychiatric disorders Insomnia	76.9% 10/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	50.0% 5/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Bruxism	53.8% 7/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	40.0% 4/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Product Issues Depressed mood	15.4% 2/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	30.0% 3/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Agitation	15.4% 2/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	10.0% 1/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Anger	15.4% 2/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	10.0% 1/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Fear	15.4% 2/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	10.0% 1/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Irritability	15.4% 2/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	10.0% 1/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Nightmare	7.7% 1/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	20.0% 2/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Restlessness	23.1% 3/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	0.00% 0/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Suicidal ideation	7.7% 1/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	20.0% 2/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Feeling guilty	0.00% 0/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	20.0% 2/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Illusion	7.7% 1/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	10.0% 1/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Affect lability	7.7% 1/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	0.00% 0/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Attention deficit hyperactivity disorder	0.00% 0/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	10.0% 1/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Depression	0.00% 0/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	10.0% 1/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Derealisation	0.00% 0/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	10.0% 1/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Dissociation	0.00% 0/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	10.0% 1/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Dysphoria	0.00% 0/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	10.0% 1/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Emotional disorder	7.7% 1/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	0.00% 0/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Feeling of despair	0.00% 0/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	10.0% 1/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Flashback	7.7% 1/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	0.00% 0/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Flight of ideas	0.00% 0/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	10.0% 1/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Intrusive thoughts	7.7% 1/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	0.00% 0/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Loss of libido	0.00% 0/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	10.0% 1/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Panic attack	0.00% 0/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	10.0% 1/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Panic reaction	0.00% 0/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	10.0% 1/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Poor quality sleep	0.00% 0/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	10.0% 1/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Suicidal behaviour	0.00% 0/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	10.0% 1/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Tic	0.00% 0/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	10.0% 1/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Psychiatric disorders Anxiety	23.1% 3/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	30.0% 3/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Nervous system disorders Headache	38.5% 5/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	80.0% 8/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Nervous system disorders Nystagmus	23.1% 3/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	30.0% 3/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Nervous system disorders Dizziness	7.7% 1/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	30.0% 3/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Nervous system disorders Disturbance in attention	0.00% 0/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	30.0% 3/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Nervous system disorders Paraesthesia	7.7% 1/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	20.0% 2/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Nervous system disorders Hypoaesthesia	7.7% 1/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	10.0% 1/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Nervous system disorders Tremor	7.7% 1/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	10.0% 1/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Nervous system disorders Head discomfort	7.7% 1/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	0.00% 0/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Nervous system disorders Lethargy	0.00% 0/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	10.0% 1/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)
Nervous system disorders Parosmia	0.00% 0/13 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)	10.0% 1/10 • During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)