Trial Outcomes & Findings for MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness (NCT NCT02427568)

NCT ID: NCT02427568

Last Updated: 2025-06-05

Results Overview

The State-Trait Anxiety Inventory (STAI) is a 20-item self-report measure of intensity of anxiety. Each item consists of a 4-point Likert rating scale ranging from 1 ('Not at all') to 4 ('Very Much So'), with higher scores indicating greater anxiety. Items were summed for a total score that ranged from 20 to 80. The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The use of the trait subscale as the primary outcome measure was intended to target those anxiety symptoms that are chronic and pervasive.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)
• Results posted on: 2025-06-05

Participant Flow

Participants were recruited through printed ads, internet ads, referrals from other psychiatrists, psychotherapists or physicians, and through word of mouth.

Participant milestones

Measure	Placebo With Therapy Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by inactive placebo supplemental dose. Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart.	MDMA-assisted Therapy (125 mg) 125 mg midomafetamine HCl administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose of 62.5 mg.
Overall Study STARTED	5	13
Overall Study COMPLETED	5	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness

Baseline characteristics by cohort

Measure	Placebo With Therapy n=5 Participants Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by inactive placebo supplemental dose. Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart.	MDMA-assisted Therapy (125 mg) n=13 Participants 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose of 62.5 mg MDMA. MDMA-assisted therapy: Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart.	Total n=18 Participants Total of all reporting groups
Age, Continuous	53.2 years STANDARD_DEVIATION 10.5 • n=5 Participants	55.5 years STANDARD_DEVIATION 7.0 • n=7 Participants	54.9 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · White/Caucasian	3 Participants n=5 Participants	12 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black/African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Baseline State-Trait Anxiety Inventory Trait (STAI-T)	62.5 units on a scale STANDARD_DEVIATION 7.31 • n=5 Participants	57.4 units on a scale STANDARD_DEVIATION 5.18 • n=7 Participants	61.1 units on a scale STANDARD_DEVIATION 7.03 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)

Population: Intent-to-treat (ITT) set

The State-Trait Anxiety Inventory (STAI) is a 20-item self-report measure of intensity of anxiety. Each item consists of a 4-point Likert rating scale ranging from 1 ('Not at all') to 4 ('Very Much So'), with higher scores indicating greater anxiety. Items were summed for a total score that ranged from 20 to 80.

The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The use of the trait subscale as the primary outcome measure was intended to target those anxiety symptoms that are chronic and pervasive.

Outcome measures

Measure	MDMA-assisted Therapy (125 mg) n=13 Participants 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose of 62.5 mg MDMA. MDMA-assisted therapy: Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart.	Placebo With Therapy n=5 Participants Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by inactive placebo supplemental dose. Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart.
Change in State Trait Anxiety Inventory (STAI) Trait Score From Baseline to Primary Endpoint	-23.5 score on a scale Standard Deviation 13.2	-8.8 score on a scale Standard Deviation 14.7

PRIMARY outcome

Timeframe: One month post-2nd experimental session

Population: Intent-to-treat (ITT) set

The State-Trait Anxiety Inventory (STAI) is a 20-item self-report measure of intensity of anxiety. Each item consists of a 4-point Likert rating scale ranging from 1 ('Not at all') to 4 ('Very Much So'), with higher scores indicating greater anxiety. Items were summed for a total score that ranged from 20 to 80.

The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The use of the trait subscale as the primary outcome measure is intended to target those anxiety symptoms that are chronic and pervasive.

Outcome measures

Measure	MDMA-assisted Therapy (125 mg) n=13 Participants 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose of 62.5 mg MDMA. MDMA-assisted therapy: Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart.	Placebo With Therapy n=5 Participants Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by inactive placebo supplemental dose. Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart.
Primary Endpoint STAI Trait Score	38.9 score on a scale Standard Deviation 10.6	48.6 score on a scale Standard Deviation 12.6

SECONDARY outcome

Timeframe: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)

Population: Intent-to-treat (ITT) set

The state subscale of the STAI (STAI-S) is a 20-item self-reported scale which assesses subjects' levels of transient, situationally oriented, anxiety. Like the trait subscale, participants respond to each item on the state subscale by selecting a response from a 4-point Likert scale ranging from 4 ("Not at all") to 1 ("Very much so"), with higher scores indicating greater anxiety. Items were summed for a total score that ranged from 20 to 80.

The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The use of the trait subscale as the primary outcome measure is intended to target those anxiety symptoms that are chronic and pervasive.

Outcome measures

Measure	MDMA-assisted Therapy (125 mg) n=13 Participants 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose of 62.5 mg MDMA. MDMA-assisted therapy: Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart.	Placebo With Therapy n=5 Participants Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by inactive placebo supplemental dose. Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart.
Change in STAI State Score From Baseline to Primary Endpoint	-22.1 score on a scale Standard Deviation 17.9	-6.0 score on a scale Standard Deviation 15.8

SECONDARY outcome

Timeframe: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)

Population: Intent-to-treat (ITT) set

The Beck Depression Inventory-II (BDI-II) is a a 21-item self-reported measure of depression according to Diagnostic and Statistical Manual IV (DSM-IV) criteria. Each item is rated on a 4-point Likert scale ranging from 0 to 3. The total score is the sum of 21 items and range from 0 to 63. Score cutoffs indicate: 0-13 minimal depression, 14-19 mild depression, 20-28 moderate depression, and 29-63 severe depression. Higher scores indicate more severe depressive symptoms.

Outcome measures

Measure	MDMA-assisted Therapy (125 mg) n=13 Participants 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose of 62.5 mg MDMA. MDMA-assisted therapy: Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart.	Placebo With Therapy n=5 Participants Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by inactive placebo supplemental dose. Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart.
Change in Beck Depression Inventory-II (BDI-II) Score From Baseline to Primary Endpoint	-20.9 score on a scale Standard Deviation 13.8	-14.6 score on a scale Standard Deviation 8.6

SECONDARY outcome

Timeframe: Baseline (3 months from enrollment) to Primary Endpoint (one month post 2nd experimental session)

Population: Intent-to-treat (ITT) set

The Global Assessment of Function (GAF) is a measure of a person's global social functioning made through clinical observation. The GAF consists of a single score, with scores ranging from 0 to 100, with 100 reflecting superior function and zero reflecting serious risk of causing harm to the self or others.

Outcome measures

Measure	MDMA-assisted Therapy (125 mg) n=13 Participants 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose of 62.5 mg MDMA. MDMA-assisted therapy: Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart.	Placebo With Therapy n=5 Participants Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by inactive placebo supplemental dose. Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart.
Change in Global Assessment of Functioning (GAF) Score From Baseline to Primary Endpoint	6.6 score on a scale Standard Deviation 9.7	3.0 score on a scale Standard Deviation 12.5

SECONDARY outcome

Timeframe: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)

Population: Intent-to-treat (ITT) set

The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item, clinician administered questionnaire used to diagnose the severity of depressive episodes. Each item has a score of 0 to 6. Overall scores are summed and range from 0 to 60. Score cutoffs indicate: 0-6 normal/symptom absent, 7-19 mild depression, 20-34 moderate depression, > 34 severe depression. Higher scores indicate greater severe depression.

Outcome measures

Measure	MDMA-assisted Therapy (125 mg) n=13 Participants 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose of 62.5 mg MDMA. MDMA-assisted therapy: Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart.	Placebo With Therapy n=5 Participants Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by inactive placebo supplemental dose. Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart.
Change in MADRS Score From Baseline to Primary Endpoint	-10.5 score on a scale Standard Deviation 8.2	-7.0 score on a scale Standard Deviation 7.2

SECONDARY outcome

Timeframe: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)

Population: Intent-to-treat (ITT) set

The Pittsburgh Sleep Quality Index (PSQI) is a measure of self-reported sleep quality over a one month period. It consists of 19 items with possible responses ranging from zero to four on a five-point scale. The PSQI consists of seven sub-scales: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime dysfunction. These are all summed to produce a single global scale. Global scores can range from 0 to 21, with higher scores reflecting poorer sleep quality, and a score below 5 indicating good sleep quality.

Outcome measures

Measure	MDMA-assisted Therapy (125 mg) n=13 Participants 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose of 62.5 mg MDMA. MDMA-assisted therapy: Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart.	Placebo With Therapy n=5 Participants Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by inactive placebo supplemental dose. Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart.
Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Primary Endpoint	-3.6 score on a scale Standard Deviation 5.4	-0.2 score on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)

Population: Intent-to-treat (ITT) set

The Posttraumatic Growth Inventory (PTGI) is a 21-item self-report measure of perceived growth or benefits occurring after a traumatic event. It contains five subscales; relationship to others, new possibilities, personal strength, spiritual change, and appreciation of life. Questions are answered on a scale from 0 (I did not experience this change) to 5 (I experienced this change to a great degree). Items are added to calculate the total PTGI score which ranges from 0 to 105, with higher scores indicative of greater growth.

Outcome measures

Measure	MDMA-assisted Therapy (125 mg) n=13 Participants 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose of 62.5 mg MDMA. MDMA-assisted therapy: Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart.	Placebo With Therapy n=5 Participants Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by inactive placebo supplemental dose. Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart.
Change in Posttraumatic Growth Inventory (PTGI) From Baseline to Primary Endpoint	12.9 score on a scale Standard Deviation 23.2	-2.6 score on a scale Standard Deviation 6.1

SECONDARY outcome

Timeframe: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)

Population: Intent-to-treat (ITT) set

The Functional Assessment of Chronic Illness Therapy Scale (FACIT-Sp) is a 27-item self-report measure of quality of life issues specifically relevant to individuals with a chronic or life-threatening illness or condition. The core questionnaire consists of four subscales: Physical Well-being, Social/Family Well-being, Emotional Well-being, and Functional Well-being. Responses range from 0 (not at all) to 4 (very much), with higher scores indicating greater well-being. For each subscale, total scores were summed and range from 0 to 16.

Outcome measures

Measure	MDMA-assisted Therapy (125 mg) n=13 Participants 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose of 62.5 mg MDMA. MDMA-assisted therapy: Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart.	Placebo With Therapy n=5 Participants Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by inactive placebo supplemental dose. Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart.
Change in Functional Assessment of Chronic Illness Therapy Scale (FACIT) From Baseline to Primary Endpoint Physical well-being	1.4 score on a scale Standard Deviation 4.4	2.8 score on a scale Standard Deviation 5.0
Change in Functional Assessment of Chronic Illness Therapy Scale (FACIT) From Baseline to Primary Endpoint Social/ family well-being	0.8 score on a scale Standard Deviation 3.4	-2.0 score on a scale Standard Deviation 2.9
Change in Functional Assessment of Chronic Illness Therapy Scale (FACIT) From Baseline to Primary Endpoint Emotional well-being	1.6 score on a scale Standard Deviation 7.1	1.0 score on a scale Standard Deviation 2.2
Change in Functional Assessment of Chronic Illness Therapy Scale (FACIT) From Baseline to Primary Endpoint Functional well-being	4.8 score on a scale Standard Deviation 5.8	1.0 score on a scale Standard Deviation 1.6
Change in Functional Assessment of Chronic Illness Therapy Scale (FACIT) From Baseline to Primary Endpoint Additional concerns	4.5 score on a scale Standard Deviation 11.9	-0.3 score on a scale Standard Deviation 5.0

SECONDARY outcome

Timeframe: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)

Population: Intent-to-treat (ITT) set

The Death Attitudes Profile (DAP) is a 32-item self-reported questionnaire that assesses individual attitudes and beliefs about death and dying. Each item on the scale is rated along a 7-point Likert scale ranging from "strongly disagree" (score of 1) to "strongly agree" (score of 7), with higher scores indicating more positive attitudes toward death.

The DAP consists of 5 dimensions: fear of death (7 items summed with total scores ranging from 7 to 49), death avoidance (5 items summed with total scores ranging from 5 to 35), neutral acceptance (5 items summed with total scores ranging from 5 to 35), approach acceptance (10 items summed with total scores ranging from 10 to 70), and escape acceptance (5 items summed with total scores ranging from 5 to 35). For each dimension, a mean scale score can be computed by dividing the total scale score by the number of items forming each scale.

Outcome measures

Measure	MDMA-assisted Therapy (125 mg) n=13 Participants 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose of 62.5 mg MDMA. MDMA-assisted therapy: Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart.	Placebo With Therapy n=5 Participants Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by inactive placebo supplemental dose. Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart.
Change in Death Attitudes Profile (DAP) From Baseline to Primary Endpoint Fear of death	-0.1 score on a scale Standard Deviation 0.6	-0.6 score on a scale Standard Deviation 1.0
Change in Death Attitudes Profile (DAP) From Baseline to Primary Endpoint Death avoidance	0 score on a scale Standard Deviation 0.8	-1.1 score on a scale Standard Deviation 1.8
Change in Death Attitudes Profile (DAP) From Baseline to Primary Endpoint Neutral acceptance	0.1 score on a scale Standard Deviation 0.6	0.2 score on a scale Standard Deviation 0.6
Change in Death Attitudes Profile (DAP) From Baseline to Primary Endpoint Approach acceptance	0.3 score on a scale Standard Deviation 0.7	-0.1 score on a scale Standard Deviation 1.1
Change in Death Attitudes Profile (DAP) From Baseline to Primary Endpoint Escape acceptance	0.4 score on a scale Standard Deviation 1.0	0 score on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)

Population: Intent-to-treat (ITT) set

The Self-Compassion Scale (SCS) is a 26-item self-reported questionnaire that assesses how respondents relate to themselves and treat themselves during difficult or painful experiences. Items are scored along a 5-point Likert-type scale ranging from 1 "almost never" to 5 "almost always." The SCS has six component (subscale) scores: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Subscale scores are calculated by computing the mean of subscale item responses.

A total self-compassion score is calculated by the sum of the subscale scores and range from 24 to 120 with higher scores indicating greater self compassion. Higher scores have been found to correlate with positive mental health outcomes, as well as decreased depression and anxiety.

Outcome measures

Measure	MDMA-assisted Therapy (125 mg) n=13 Participants 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose of 62.5 mg MDMA. MDMA-assisted therapy: Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart.	Placebo With Therapy n=5 Participants Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by inactive placebo supplemental dose. Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart.
Change in Self-Compassion Scale (SCS) From Baseline to Primary Endpoint	0.4 score on a scale Standard Deviation 0.7	-0.04 score on a scale Standard Deviation 0.5

Adverse Events

Placebo With Therapy (Blinded)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

MDMA-assisted Therapy (125 mg) (Blinded)

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo Group Open-label Crossover to Unblinded MDMA-assisted Therapy (125 mg)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

MDMA Group Open-label MDMA-assisted Therapy (125 mg)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo With Therapy Group 12-month Follow-up

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

MDMA-assisted Therapy Group 12-month Follow-up

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Measure	Placebo With Therapy (Blinded) n=5 participants at risk Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by (optional) inactive placebo supplemental dose. Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart.	MDMA-assisted Therapy (125 mg) (Blinded) n=13 participants at risk 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a (optional) supplemental dose of 62.5 mg MDMA. MDMA-assisted therapy: Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart.	Placebo Group Open-label Crossover to Unblinded MDMA-assisted Therapy (125 mg) n=5 participants at risk Unblinded Crossover 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 3 open-label experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a (optional) supplemental dose of 62.5 mg MDMA.	MDMA Group Open-label MDMA-assisted Therapy (125 mg) n=13 participants at risk Open-Label 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered during open-label 1 experimental session. Initial dose possibly followed 1.5 to 2.5 hours later by a (optional) supplemental dose of 62.5 mg MDMA.	Placebo With Therapy Group 12-month Follow-up n=5 participants at risk Follow-up with placebo with therapy group 12 months after end of Stage 2.	MDMA-assisted Therapy Group 12-month Follow-up n=13 participants at risk Follow-up with MDMA-assisted therapy group 12 months after end of Stage 1.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chordoma	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Nervous system disorders Cerebrovascular accident	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Nervous system disorders Spinal cord paralysis	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Infections and infestations Meningitis	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Infections and infestations Sepsis	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .

Other adverse events

Measure	Placebo With Therapy (Blinded) n=5 participants at risk Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by (optional) inactive placebo supplemental dose. Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart.	MDMA-assisted Therapy (125 mg) (Blinded) n=13 participants at risk 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a (optional) supplemental dose of 62.5 mg MDMA. MDMA-assisted therapy: Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart.	Placebo Group Open-label Crossover to Unblinded MDMA-assisted Therapy (125 mg) n=5 participants at risk Unblinded Crossover 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 3 open-label experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a (optional) supplemental dose of 62.5 mg MDMA.	MDMA Group Open-label MDMA-assisted Therapy (125 mg) n=13 participants at risk Open-Label 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered during open-label 1 experimental session. Initial dose possibly followed 1.5 to 2.5 hours later by a (optional) supplemental dose of 62.5 mg MDMA.	Placebo With Therapy Group 12-month Follow-up n=5 participants at risk Follow-up with placebo with therapy group 12 months after end of Stage 2.	MDMA-assisted Therapy Group 12-month Follow-up n=13 participants at risk Follow-up with MDMA-assisted therapy group 12 months after end of Stage 1.
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Psychiatric disorders Anxiety	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Cardiac disorders Arrhythmia	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Gastrointestinal disorders Abdominal Pain	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	15.4% 2/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Nervous system disorders Balance Disorder	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Psychiatric disorders Bruxism	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Nervous system disorders Clumsiness	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Injury, poisoning and procedural complications Contusion	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	15.4% 2/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Psychiatric disorders Depressed mood	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Psychiatric disorders Depression	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Gastrointestinal disorders Diarrhoea	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Psychiatric disorders Dissociation	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Injury, poisoning and procedural complications Fall	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
General disorders Fatigue	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	23.1% 3/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Psychiatric disorders Hypomania	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Infections and infestations Influenza	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	15.4% 2/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Psychiatric disorders Insomnia	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	30.8% 4/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	40.0% 2/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	15.4% 2/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Vascular disorders Lymphoedema	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Gastrointestinal disorders Nausea	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Renal and urinary disorders Nephrolithiasis	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
General disorders Pain	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Nervous system disorders Paraesthesia	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Nervous system disorders Sinus Headache	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Injury, poisoning and procedural complications Skin Abrasion	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Musculoskeletal and connective tissue disorders Tenosynovitis stenosans	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Infections and infestations Tinea Infection	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Injury, poisoning and procedural complications Tooth Fracture	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Infections and infestations Upper respiratory tract infection	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Reproductive system and breast disorders Vaginal Discharge	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Investigations Weight Decreased	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
General disorders Chest Pain	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Musculoskeletal and connective tissue disorders Muscle Spasm	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Nervous system disorders Neuropathy peripheral	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Musculoskeletal and connective tissue disorders Plantar fasciitis	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Injury, poisoning and procedural complications Skeletal injury	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Infections and infestations Viral upper respiratory tract infection	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Investigations Heart rate irregular	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Nervous system disorders Muscle contractions	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Infections and infestations Oral herpes	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Vascular disorders Hot flush	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Nervous system disorders Tremor	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Psychiatric disorders Drug abuse	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Nervous system disorders Sciatica	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Gastrointestinal disorders Oesophageal pain	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Injury, poisoning and procedural complications Thermal burn	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Musculoskeletal and connective tissue disorders Scleroderma	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	20.0% 1/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Nervous system disorders Aphasia	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .
Infections and infestations Post procedural cellulitis	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	7.7% 1/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/5 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .	0.00% 0/13 • Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .

Additional Information

Study Director

Lykos Therapeutics

Phone: 877-627-7722

Email: trialdata@lykospbc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place