The occurrence and (if applicable) frequency, emotional valence, and functional impact of any reactivation events was determined. To determine if reactivation had occurred, participants were asked if they had any flashbacks or recurrence of any effects of the study drug experience.

The EDI was performed to assess the extent of a participant's dissolution of ego after receiving BPL-003 on Day 0 (dosing day). The inventory comprises 8 statements. Participants rated their agreement to each statement by marking on a visual analogue scale from 0 ("no, not more than usually") to 100 ("yes, entirely or completely"). Higher scores are indicative of more intense ego dissolution. In practice, this means participants with higher scores could have a reduced sense of having a distinct, separate self; greater feelings of unity with the environment or universe; a loss of self-referential thoughts or identity; or altered boundaries between 'self' and 'other'. A 'total EDI score' was calculated for each participant as the average of their individual-item scores. The total EDI score is presented.

The MEQ-30 was performed to assess the extent of a participant's mystical experience after receiving BPL-003 on Day 0 (dosing day). The questionnaire comprises a list of 30 phenomena, with subscales to measure mystical, positive mood, transcendence, and ineffability factors, measured on a 0 to 5 scale (0=none; not at all to 5=extreme). A 'total MEQ-30 score' was calculated for each participant as the average of all their responses.

A complete mystical experience was defined as reaching or exceeding a score of 3 on all four sub-domains (mystical, positive mood, transcendence of time and space, and ineffability) of the MEQ-30 scale.

The EDI was performed to assess the extent of a participant's dissolution of ego after receiving BPL-003 on Day 0 (dosing day). The inventory comprises 8 statements. Participants rated their agreement to each statement by marking on a visual analogue scale from 0 ("no, not more than usually") to 100 ("yes, entirely or completely"). Participants were classed as experiencing an ego dissolution if they had a total score of >50.0 out of 100 on the EDI scale.

After BPL-003 dosing, participants had the option to participate in a one-to-one guided interview with independent researchers trained in microphenomenology methods to describe their psychedelic experience. Temporal aspects of drug effects (e.g., sensory, cognitive, metacognitive, and sense of self/other/connectedness) were elicited through open-ended interview questions.

Key themes from qualitative feedback on the treatment model was sought from therapists on frequency and duration of psychotherapy sessions, implementation of therapy manual, and overall therapy model. Feedback was obtained in a qualitative interview with each therapist after each participant's last integration session (between Day 15 and Day 42).

After BPL-003 dosing, participants had the option to participate in a semi-structured interview. The interviews were topic-guided, qualitative interviews to understand psychological changes shortly after dosing on Day 1, and on Day 84.

Using the TLFB interview, the PDD in the 85 days before Day -3 (or start of detox) vs PDD post-dosing measured on Days 14, 28, 56, and 84 were determined to assess alcohol use.

The C-SSRS was performed at screening, on Day 0 (dosing day), and on Days 1, 7, and 84 post-dose. Participants were counted if they answered 'yes' to any question. At baseline, the C-SSRS assessed the worst-point suicidal ideation experienced during the participant's lifetime. Beyond baseline, suicidal ideation and behaviour since last visit was assessed.

The number (%) of participants with any clinically significant abnormal laboratory tests (routine haematology, clinical chemistry and coagulation) is presented

All particpants were included in the safety analysis set and analyzed.

The number (%) of participants with any clinically significant abnormal vital signs (blood pressure, heart rate and temperature) result is presented

All participants were included in the safety analysis set and analyzed.

The C-SSRS was performed at screening, on Day 0 (dosing day), and on Days 1, 7, and 84 post-dose. Participants were counted if they answered 'yes' to any question. At baseline, the C-SSRS assessed the worst-point suicidal ideation experienced during the participant's lifetime. Beyond baseline, suicidal ideation and behaviour since last visit was assessed.

One participant who had answered 'yes' for 'wish to be dead' at screening also answered 'yes' for 'wish to be dead' post-dose on Day 0.

All subsequent C-SSRS assessments were negative for the participant. Additionally, post-baseline C-SSRS assessments for the remaining 12 participants were all negative.

The RDQ was a brief assessment scale to ensure that ahead of discharge after BPL-003 dosing, participants:

• Were fully responsive, aware of their surroundings, and reacted adequately
• The acute psychedelic effects of the drug had completely subsided
• Were fully orientated (name, location, time)
• Had normal (or only slightly elevated) blood pressure and pulse rate, and normal breathing frequency and body temperature
• Had a stable gate, normal muscle coordination, and could walk safely
• Had only mild to moderate potential side affects that did not need to be medically monitored
• Had no acute suicidal ideations or suicidal intentions
• Possible distress or feelings of overwhelm had sufficiently subsided and the participant felt safe to be discharged.

Readiness for discharge was assessed at 90 minutes post-dose and then every 30 minutes until the participant was deemed ready for discharge (eg, the answer was 'yes' to all of the above items).

All 13 participants were included in the analysis.

The occurrence and (if applicable) frequency, emotional valence, and functional impact of any reactivation events was determined. To determine if reactivation had occurred, participants were asked if they had any flashbacks or recurrence of any effects of the study drug experience.

The ReAQ was added to the protocol after some participants had already completed their Day 84 visit; therefore, the assessment could not be completed by all study participants. For ongoing participants, the ReAQ was completed at the next applicable visit.

The MEQ-30 was performed to assess the extent of a participant's mystical experience after receiving BPL-003 on Day 0 (dosing day). The questionnaire comprises a list of 30 phenomena, with subscales to measure mystical, positive mood, transcendence of space and time, and ineffability factors, measured on a 0 to 5 scale (0=none; not at all to 5=extreme). A 'total MEQ-30 score' was calculated for each participant as the average of all their responses. The total MEQ-30 score is presented. The higher the score, the greater the mystical experience. A total score of ≥3 was considered to be a significant mystical experience.

One participant did not have the MEQ-30 performed.

The EDI was performed to assess the extent of a participant's dissolution of ego after receiving BPL-003 on Day 0 (dosing day). The inventory comprises 8 statements. Participants rated their agreement to each statement by marking on a visual analogue scale from 0 ("no, not more than usually") to 100 ("yes, entirely or completely"). Higher scores are indicative of more intense ego dissolution. In practice, this means participants with higher scores could have a reduced sense of having a distinct, separate self; greater feelings of unity with the environment or universe; a loss of self-referential thoughts or identity; or altered boundaries between 'self' and 'other'. A 'total EDI score' was calculated for each participant as the average of their individual-item scores. The total EDI score is presented.

One participant did not have the EDI performed.

The MEQ-30 was performed to assess the extent of a participant's mystical experience after receiving BPL-003 on Day 0 (dosing day). The questionnaire comprises a list of 30 phenomena, with subscales to measure mystical, positive mood, transcendence, and ineffability factors, measured on a 0 to 5 scale (0=none; not at all to 5=extreme). A 'total MEQ-30 score' was calculated for each participant as the average of all their responses.

A complete mystical experience was defined as reaching or exceeding a score of 3 on all four sub-domains (mystical, positive mood, transcendence of time and space, and ineffability) of the MEQ-30 scale.

One participant did not have the MEQ-30 performed.

The EDI was performed to assess the extent of a participant's dissolution of ego after receiving BPL-003 on Day 0 (dosing day). The inventory comprises 8 statements. Participants rated their agreement to each statement by marking on a visual analogue scale from 0 ("no, not more than usually") to 100 ("yes, entirely or completely"). Participants were classed as experiencing an ego dissolution if they had a total score of >50.0 out of 100 on the EDI scale.

One participant did not have the EDI performed.

After BPL-003 dosing, participants had the option to participate in a one-to-one guided interview with independent researchers trained in microphenomenology methods to describe their psychedelic experience. Temporal aspects of drug effects (e.g., sensory, cognitive, metacognitive, and sense of self/other/connectedness) were elicited through open-ended interview questions.

This was a qualitative endpoint. Themes prevalent at the peak of the experience (e.g., with ≥50% [>4 participants] reporting them) are presented. One participant withdrew and one participant refused the optional interview.

Key themes from qualitative feedback on the treatment model was sought from therapists on frequency and duration of psychotherapy sessions, implementation of therapy manual, and overall therapy model. Feedback was obtained in a qualitative interview with each therapist after each participant's last integration session (between Day 15 and Day 42).

Key themes from qualitative feedback on the treatment model are presented. Please note: as the feedback was sought from therapists and not participants, n=6 refers to the number of therapists that provided feedback via a qualitative interview.

Using the TLFB interview, the PAD in the 85 days before Day -3 (or start of detox) vs the PAD post-dosing measured on Days 14, 28, 56, and 84 were determined to assess alcohol use.

Data was not collected for one participant.

Using the TLFB interview, the PHDD in the 85 days before Day -3 (or start of detox) vs PHDD post-dosing measured on Days 14, 28, 56, and 84 were determined to assess alcohol use.

Data was not collected for one participant.

Using the TLFB interview, the PDD in the 85 days before Day -3 (or start of detox) vs PDD post-dosing measured on Days 14, 28, 56, and 84 were determined to assess alcohol use.

Data was not collected for one participant.

After BPL-003 dosing, participants had the option to participate in a semi-structured interview. The interviews were topic-guided, qualitative interviews to understand psychological changes shortly after dosing on Day 1, and on Day 84.

Key themes from qualitative feedback from participants are presented. Ten participants took part in this optional semi-structured interview.