Clinical trial NCT05200936
Conditions: ADHD Attention Deficit Disorder
Sponsor: Mind Medicine, Inc.
Start date: 2021-12-17; Completion date: 2023-12-04
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study measures the safety and efficacy of repeated low dose MM-120 as treatment for ADHD in adults: a multi-center, randomized, double-blind, placebo-controlled

Detailed description:
This study is a multi-center, randomized, double-blind, placebo-controlled Phase 2a study of low dose MM-120 (20 μg) compared with a placebo administered for 6 weeks (twice a week on a 3/4-day schedule).

Low dose MM-120 (20 μg) is about 20% of the dose typically consumed for recreational psychedelic purposes.

There will be a 1:1 randomization, double-blind, to MM-120 or placebo with the aim to reach 26 evaluable patients in each of the 2 arms at Week 6.

Arms: arm 1: A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. arm 2: A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks.
Interventions: intervention 1: MM-120 intervention 2: Placebo
Intervention descriptions: intervention 1: MM-120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM-120 manifests primarily visual, as well as auditory, hallucinations. intervention 2: A treatment which is designed to have no therapeutic value.

Protocol documents:
Prot_000.pdf: 
D-LYSERGIC ACID DIETHYLAMIDE (LSD) D-TARTRATE (MM-120)  
Mind Medicine, Inc. 
Protocol MMED007 
Version 5, 09-MAR-2022– Confidential –Page 1 of 115 
 
 
 
 
SAFETY AND EFFICACY OF REPEATED LOW DOSE D-LYSERGIC ACID 
DIETHYLAMIDE (LSD) D-TARTRATE (MM-120) AS TREATMENT FOR ADHD 
IN ADULTS: A MULTI-CENTER, RANDOMIZED, DOUBLE- BLIND, PLACEBO-
CONTROLLED PHASE 2A PROOF OF CONCEPT TRIAL 
 
 
Sponsor Protocol Number:  
MMED007 
Investigational Product: 
D-LYSERGIC ACID DIETHYLAMIDE (LSD) D-
TARTRATE (MM-120) 
Sponsor: 
 
 
 
Mind Medicine, Inc. 
 
 
 
 
 
1325 Airmotive Way, Suite 175A, Reno,  
 
 
 
 
 
NV 89502  
 
 
 
 
 
USA 
Medical Monitors:  
 
Sponsor Medical Monitor 
 
 
 
 
 
 
 
 
 
 
 
 
  
GCP Medical Monitor 
 
 
 
 
 
 
 
 
 
 
 
 
  
Protocol Version/Date: 
 
Version 5, 09-MAR-2022 
 


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SIGNATURES 
 
Sponsor Signature 
 
Study Title:  Safety and efficacy of repeated low dose D-LYSERGIC ACID  
 
 
 
DIETHYLAMIDE (LSD) D-TARTRATE (MM-120) as treatment for  
 
 
ADHD in adults: a multi-center, randomized, double-blind, placebo- 
 
 
controlled Phase 2a Proof of Concept Trial 
 
Study Number: 
MMED007 
Version/Date: 
Version 5, 09-MAR-2022 
 
I agree to the content of this protocol. 
 
 
 
Signed: 
 
________________________________ 
 
Date:   
 
________________________________ 
 
Name and title:  
 
 
 
 
  
 
 
 
Mind Medicine Inc. 
 
 
 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) D-TARTRATE (MM-120)  
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Protocol MMED007 
Version 5, 09-MAR-2022– Confidential –Page 3 of 115 
 
Signature of Principal Investigator 
 
Study Title:  Safety and efficacy of repeated low dose D-LYSERGIC ACID  
 
 
 
DIETHYLAMIDE (LSD) D-TARTRATE (MM-120) as treatment for  
 
 
ADHD in adults: a multi-center, randomized, double-blind, placebo- 
 
 
controlled Phase 2a Proof of Concept Trial 
 
Study Number: 
MMED007 
Version/Date: 
Version 5, 09-MAR-2022 
I, the undersigned, have read the protocol and agree to conduct this protocol in accordance 
with ethical principles that have their origin in the Declaration of Helsinki and are 
consistent with the International Conference on Harmonisation (ICH) guidelines for Good 
Clinical Practice (GCP), and all applicable local and federal/Country regulatory 
requirements. 
I will provide copies of the protocol and access to all information furnished by the Sponsor 
to study personnel under my supervision. I will discuss this material with them to ensure 
they are fully informed about the investigational product and the study. I understand that 
the study may be terminated, or enrolment suspended at any time by Sponsor with or 
without cause, or by me if it becomes necessary to protect the best interests of the study 
subjects. 
 
 
 
Signed: 
 
________________________________ 
 
Date:   
 
________________________________ 
 
Name and title:  
________________________________ 
 
Address: 
 
________________________________ 
 
Telephone number:  ________________________________ 
 
 


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1. 
PROTOCOL SYNOPSIS 
Study title 
Safety and efficacy of repeated low dose D-lysergic acid diethylamide (LSD) D-
Tartrate (MM-120) as treatment for ADHD in adults: a multi-center, randomized, 
double-blind, placebo- controlled Phase 2a Proof of Concept Trial 
Investigational 
Medicinal 
Product 
D-LYSERGIC ACID DIETHYLAMIDE (LSD) D-TARTRATE 
(MM-120) 
Phase of 
Development 
Phase 2a 
Study Population 
Fifty-two (52) eligible subjects aged ≥ 18 and ≤ 65 years 
with 
attention-deficit/hyperactivity 
disorder 
(ADHD) 
either previously diagnosed or diagnosed at screening 
Sponsor 
Mind Medicine, Inc. 
Study sites 
 
Objectives 
Primary Objective 
To assess the treatment efficacy vs placebo of repeated low doses (20 μg) of MM-
120 for six weeks in adult subjects with ADHD measured by Adult Attention Deficit 
Investigator Symptom Rating Scale (AISRS). 
Secondary Objectives 
1. To assess treatment efficacy vs placebo measured by change from baseline in 
AISRS after 1 week of treatment. 
2. To assess treatment efficacy vs placebo based on the proportion of subjects who 
experience at least a 1-point decrease in the Clinical Global Impression - 
Severity of Illness Scale (CGI-S). 
3. To assess treatment efficacy vs placebo measured by change from baseline in 
CGI-S. 
4. To assess the safety and tolerability by Adverse Event (AE) and Serious 
Adverse Event (SAE) assessment. 
Study Design  
 
This study is a multi-center, randomized, double-blind, placebo-controlled Phase 2a 
study of low dose MM-120 (20 μg) compared with a placebo administered for 6 
weeks (twice a week on a 3/4-day schedule [± 1 day]). 
Low dose MM-120 (20 μg) is about 20% of the dose typically consumed for 
recreational psychedelic purposes.  
There will be a 1:1 randomization, double-blind, to MM-120 or placebo with the 
aim to reach 26 evaluable subjects in each of the 2 arms at Week 6. 
There will be 2 arms: 
● 
Arm 1-Placebo: a total of 26 subjects will receive a placebo identical in 
appearance to the investigational medicinal product (IMP) administered orally 
twice weekly (e.g., Tuesday/Friday) for 6 weeks.  
● 
Arm 2-MM-120: a total of 26 subjects will receive 20 μg of MM-120 
administered orally twice weekly for 6 weeks.  
Subjects will be evaluated at Baseline, Week 1, Week 6 and at Week 10, for AISRS 
and CGI-S by trained study personnel; the primary endpoint will be based on 
evaluation of AISRS at Baseline and at Week 6. 
Screening and Baseline visits: 
● Potential study subjects who provide informed 
consent will have eligibility 


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evaluated/confirmed at 2 visits: 1) Screening 
(Visit 1); 2) Baseline (Visit 2). The screening 
visit will occur up to 4 weeks prior to 
Baseline visit. An assessment will be made to 
confirm or make the ADHD diagnosis with the 
Mini International Neuropsychiatric Interview 
(MINI), and other eligibility criteria. The 
subject must have an AISRS score of ≥ 26, and a 
CGI-S of ≥ 4 at screening and must meet all 
other eligibility criteria. 
●
The baseline visit will occur at the clinic before Day 1
and the AISRS score will be confirmed. If there is a ≥13-
point change in the AISRS between the screening visit
assessment and the baseline assessment, or if the subject
does not return for the baseline AISRS, the subject will
not be randomized and will be terminated from the study.
Eligible subjects will be randomized on Day 1 to either
20 μg of MM-120 or to matching placebo and begin the
double-blind treatment period on Day 1.
Test days: 
●
The double-blind treatment period will be 6 weeks in duration, with dosing
twice weekly (every 3 to 4 days). Day 1 will be the first day of dosing. At the
end of 6 weeks, subjects will be assessed by a study physician. All subjects and
site staff will remain blinded to the treatment arm.
Follow-up: 
●
There will be a single follow-up visit to occur 4 weeks after the last double-
blind treatment visit (i.e., at Week 10).
Randomization 
Drugs 
This is a double-blind study. Subjects will receive either MM-120 as a single dose 
containing 20 μg (D-LSD D-tartrate) freebase-equivalent or matching placebo. 
Inclusion Criteria 
All inclusion criteria will be based on the judgment of the Investigator. For inclusion 
in the study, subjects must meet all of the following criteria: 
1.
Ability and willingness to provide written, informed consent prior to initiation
of any study-related procedures and to adhere to all study requirements.
NOTE: The subject (i.e., not a legally authorized representative) must be
cognitively able to understand the requirements of the study and provide the
informed consent
2.
Age ≥ 18 and ≤ 65 years at Screening.
3.
Subjects with the diagnosis of Diagnostic and Statistical Manual of Mental
Disorders-5 (DSM-5) ADHD, as determined by clinical evaluation and
confirmed by structured interview (MINI).
4.
AISRS total score of ≥ 26 at screening.
5.
CGI-S score of ≥ 4 at screening.
6.
Must be willing to receive IMP dose twice weekly. On day 1, the subject will
come to the site clinic and must be willing to take a taxi or public transportation
home or be accompanied by a caregiver and not drive a car, use heavy
equipment, or participate in any other dangerous activity for the remainder of
the day after receiving IMP (NOTE: at any protocol visit after Day 1 dosing,
dosing visits may occur at the subject’s home at the discretion of the PI,
conducted by one of the study investigators or delegate and administered under
supervision followed by the performance of the same procedures done at the


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clinic including safety monitoring. If early withdrawal is considered due to any 
safety issue identified, the Sponsor’s medical monitor should be notified. If a 
remote visit is conducted due to any reason related to the COVID-19 pandemic, 
notification must be sent to the Medical Monitor’s dedicated email address and 
Urgent Safety Measures as outlined in this protocol must be followed.) 
7.
Must be willing to refrain from more than 6 standard alcoholic drinks per week
(1 standard drink corresponds to 0.1 L wine, 0.3 L beer, or 4 cL liquor), more
than 10 cigarettes a day, and more than 2 cups of coffee a day throughout the
study treatment period (6 weeks) and until the last study visit is complete (EoS
or ET).
Exclusion Criteria 
Subjects should not be included in the study if any of the following exclusion criteria 
are met: 
1. Past or present diagnosis of a primary psychotic disorder or first
degree relative with a psychotic disorder.
2.
Past or present bipolar disorder (DSM-5).
3.
Other current psychiatric disorders that, in the opinion of the Investigator or
medical supervisor, may confound the results of the study (e.g., obsessive-
compulsive disorder, dysthymic disorder, panic disorder, dissociative disorder,
anorexia nervosa or bulimia nervosa)
4.
Subjects with past 
 to the screening visit) or present history of
substance use disorder (except nicotine, provided subject does not smoke more
than 
 cigarettes a day).
5.
Somatic disorders including Central Nervous System (CNS) involvement of
cancer, severe cardiovascular disease, untreated hypertension, severe liver
disease (liver enzyme increase by more than 3x the upper limit of normal except
unconjugated hyperbilirubinemia due to Gilbert’s Disease, per Investigator),
severely impaired renal function (estimated creatinine clearance < 50 mL/min
by CKD-EPI formula), or anything else that, in the judgment of the Investigator
or medical supervisor, poses too great a potential for side effects.
6.
Any lifetime history of suicide attempt; or
 (
active suicidal thoughts or ideation (defined as a suicidal 
ideation score of 2 or greater in the Columbia-Suicide Severity Rating Scale 
[C-SSRS]); or endorsement of any suicidal behavior on the C-SSRS within the 
 to the screening visit. 
7.
Likely to require psychiatric hospitalization during the course of the study.
8.
Once consent is signed, subject not willing or safely able to stop any
prescription or non-prescription ADHD medications during screening and prior
to the baseline visit through final study visit, EoS or ET. A list of prohibited
medications is provided in Appendix 1.
9.
Plan to start, stop, or alter the use of any medications, supplements, or other
therapeutics from Baseline until the EoS or ET (see Appendix 1 for list of
prohibited medications).
10. Plan to start, stop or alter the use of psychotherapy, massage, meditation,
acupuncture, hypnosis, yoga, or other similar therapy/activity from the time of
providing informed consent until EoS or ET.
11. 
12. Likely to need any psychiatric medications with the potential to confound
interpretation of study results or impact safety, at the discretion of the
Investigator, in the 10 weeks following Baseline up to EoS or ET.
13. Use of investigational medication/treatment in the past 30 days prior to the
screening visit.
14. 
 at Screening OR Baseline. 


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15. Clinically significant abnormal baseline laboratory, VSs, and ECG values 
which include the following:  
o Have evidence of clinically significant hepatic disorder (e.g., 
alanine aminotransferase [ALT] or aspartate aminotransferase 
[AST] >3X ULN (except for Gilbert’s disease). 
o Any clinically significant abnormal metabolic or hematologic 
screen, per Investigator or medical supervisor decision. 
o Exclusionary blood pressure: > 140 mm Hg (systolic) or > 90 mm 
Hg (diastolic); heart rate <45 beats/minute or >90 beats/minute 
after an approximately 5-minute supine or semi-supine rest. 
NOTE: If the first measurement of a subject’s heart rate is >90 
beats/minute, a second recording is allowed after an additional 
approximately 5-minute supine rest. 
o Exclusionary ECG parameters: QTcF > 450 msec (men), QTcF 
>470 msec (women). 
o Any clinically significant abnormal electrocardiogram (ECG) 
finding (e.g., uncontrolled atrial fibrillation, ischemia) at Screening 
(Visit 1) or Baseline (Visit 2), as determined by the Investigator or 
medical supervisor (in consultation with a cardiologist, if needed). 
16. Any other condition, therapy, laboratory abnormality, or other 
circumstance that, in the opinion of the Investigator or medical 
supervisor, may pose additional risk to the subject from 
participation in the study, may interfere with the subject’s ability 
to comply with study procedures, may make participation in the 
study not in the subject’s best interest or may confound the results 
of the study. 
17. Prior history or ongoing neuropsychiatric signs or symptoms 
associated with COVID-19 such as development of, or current 
disorder, during or after a COVID-19 infection including anxiety, 
memory loss, confusion, depression, delirium, agitation, or 
psychosis.  
18. Women of childbearing potential (WOCBP) (i.e., physiologically 
capable of becoming pregnant) who are unwilling or unable to use 
a highly effective method of contraception, as defined in 
Appendix 2, for the duration of the study, OR Men physiologically 
capable of fathering a child who are sexually active with WOCBP 
but are unwilling or unable to use barrier contraception (e.g., 
condom with or without spermicidal cream or jelly) for the 
duration of the study  
NOTE: See Appendix 2 for definitions of WOCBP and highly 
effective methods of contraception and for information about 
unacceptable methods of contraception. 
19. Women who are currently pregnant or breastfeeding or plan to 
become pregnant or breastfeed during the study. 
20. Men who plan to donate sperm during the study. 
21. Use of weight loss drugs within 
 screening until the EoS or ET. 
22. Subjects who are either unable or unwilling to consume alcohol in any amount 
(including due to religious or personal reasons). 
23. Subjects who have a change in AISRS score of ≥13-point 
change between screening and baseline visits. 


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Investigational 
Product 
Subjects will be treated as described below with doses of MM-120 or placebo. Arm 
1 – placebo (Ethanol 0.16 g aqua pur ad 1 mL), twice weekly for 6 weeks, for a total 
of 12 doses. 
Arm 2 – MM-120 (LSD-tartrate 0.029 mg [corresp. 0.02 mg LSD], ethanol 0.16 g, 
aqua pur ad 1 mL), twice weekly for 6 weeks for a total of 12 doses. 
Patients and study staff will remain blinded to treatment arm.  
Protocol 
Adherence 
An education program will be in place for subjects and additional for subjects who 
miss a dosing appointment.  
IMP administration will be performed at the site on Day 1 or at home after Day 1 
per PI decision and supervised by study personnel. On Day 1, subjects must come 
to the site clinic and be willing to take a taxi or public transportation home or be 
accompanied by a caregiver. Subjects will be instructed that they cannot drive or 
operate heavy machinery or any other task that could be dangerous when impaired 
for the remainder of the day after receiving IMP.  
Endpoints 
Primary endpoint: 
Mean change from baseline in ADHD symptoms, as assessed by the AISRS after 6 
weeks of treatment. The AISRS total score consists of 18 items from the original 
Attention-Deficit/Hyperactivity Disorder - Rating Scale (ADHD-RS), which were 
derived based on DSM-5 criteria for ADHD. The ADHD-RS includes 9 items that 
address symptoms of inattention, and 9 items that address symptoms of impulsivity 
and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range 
from 0 to 54. A higher score corresponds to a worse severity of ADHD. 
Secondary endpoints: 
ADHD-related endpoints 
● 
Key secondary endpoint: change from baseline in AISRS after 1 week (2 doses) 
of treatment. 
● 
Occurrence of subjects who experience at least a 1-point decrease in the CGI-
S 
● 
Change from baseline in CGI-S after 1 week (2 doses) of treatment and after 6 
weeks of treatment 
● 
Change from baseline in subject self-assessment by the Adult ADHD Self-
Report Scale (ASRS) and Connors’ Adult ADHD Rating Scale (CAARS). 
Safety Endpoints 
● 
Vital signs (supine blood pressure, heart rate)  
● 
12-lead safety ECG 
● 
Adverse events (e.g., psychological and/or physiological adverse events)  
● 
Columbia-Suicide Severity Rating Scale (C-SSRS) 
● 
Safety laboratory evaluation and Urine pregnancy testing 
Pharmacokinetic outcomes 
● 
Blood samples for PK evaluation will be collected for 6 hours after the 
administration of the IMP on day 1.  
● 
Cmax 
● 
Tmax 
● 
AUC 
● 
T1/2 
Acute effects (Pharmacodynamic) endpoints 
● 5 Dimensions of Altered States of Consciousness scale (5D-
ASC),  
● Mystical Experience Questionnaire (MEQ),  
● Drug effect Visual Analog Scale (VAS) 
Exploratory Endpoints: 


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● Sleep quality/ duration rating will be evaluated based on daily 
diary entries and details of the analysis will be included in the 
SAP. 
Statistical 
Methods 
Statistical Design and Primary Endpoint 
This is a randomized, double-blind, placebo-controlled, Phase 2 trial that will 
evaluate the effects of MM-120 in adult subjects with ADHD. The primary endpoint 
is the change from baseline in AISRS score after 6 weeks of treatment. The effect 
will be estimated using the mean improvement in the active arm vs the placebo arm. 
Eligible subjects that consent to participate will be randomized in a 1:1 allocation. 
Determination of Sample Size  
Randomizing 26 subjects per arm, if the true efficacy of MM-120 reaches a 
standardized mean improvement over placebo of 0.60, will allow rejection of the 
null hypothesis that active is not better than placebo at a one-sided p-value < 0.10 
with 80% power.  
The minimum estimated standardized effect size resulting in a p-value < 0.10 is 0.38 
while an estimated standardized effect size < 0.56 will result in a one-sided p-value 
< 0.025. 
Duration of Study 
The duration of a subject’s participation in the trial is up to 14 weeks, including: 
● 
Screening period: up to 4 weeks prior to randomization in each cohort. 
● 
Treatment period: 6 weeks of blinded treatment 
● 
Follow-up: 4 weeks after the end of treatment. 
Lab Parameters + 
ECG 
● 
Hematology 
● 
Serum biochemistry 
● 
Urine pregnancy test 
● 
 
● 
12-lead safety ECG. 
 
 
 
 


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2. 
TABLE OF CONTENTS


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3. 
LIST OF ABBREVIATIONS 
ADHD  
 
Attention-deficit/hyperactivity disorder 
AE 
 
 
Adverse event 
AISRS  
 
Adult ADHD investigator symptom rating scale 
ADHD-RS  
 
Attention-deficit/hyperactivity disorder-rating scale 
ALT 
 
 
alanine aminotransferase 
AST 
 
 
aspartate aminotransferase 
ASRS  
 
Adult attention-deficit/hyperactivity disorder self-reporting rating  
 
 
 
scale 
AUC 
 
 
area under the curve concentration in plasma 
BMI 
 
 
body mass index 
BP 
 
 
blood pressure 
CBD 
 
 
cannabidiol 
CAARS 
 
Connors’ adult ADHD rating scale 
CAARS-L-SR  
Connors’ adult ADHD rating scale self-report long form 
CAARS-S-OR  
Connors’ adult ADHD rating scale observer-rated short screening 
CGI-S  
 
Clinical global impression-severity scale 
CKD-EPI 
 
Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation 
cGMP  
 
current Good Manufacturing Practices 
Cmax  
 
maximum serum concentration 
COVID-19 
 
coronavirus disease 2019 
CRF 
 
 
Case report form 
CRP 
 
 
C-reactive protein 
CSR 
 
 
clinical study report 
C-SSRS 
 
Columbia-suicide severity rating scale 
C-SSRS-SLV  
Columbia-Suicide Severity Rating Scale-Since Last Visit 
CYP 
 
 
cytochrome P450 
5D-ASC 
 
5 dimensions of altered states of consciousness scale 
DMT  
 
dimethyltryptamine 
DSM-5  
 
Diagnostic and statistical manual version 5 
ECG 
 
 
Electrocardiogram 
eCRF  
 
Electronic case report form 
EDC 
 
 
Electronic data capture 
EOS 
 
 
End of Study 
eGFR  
 
estimated glomerular filtration rate 
ET 
 
 
Early Termination 
FSH 
 
 
follicle-stimulating hormone 
GCP 
 
 
Good clinical practice 
GDP 
 
 
Good Distribution Practice 
GGT 
 
 
gamma-glutamyl transferase 
HR 
 
 
heart rate 
IB 
 
 
Investigator’s brochure 
ICF 
 
 
informed consent form 
ICH 
 
 
International Conference on Harmonisation  
IE 
 
 
intercurrent event 
IEC 
 
 
Institutional Ethics Committee 
IMP 
 
 
Investigational medicinal product 


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LSD 
 
 
Lysergic acid diethylamide 
MAOI  
 
monoamine oxidase inhibitor 
MCH  
 
mean corpuscular hemoglobin 
MCHC  
 
mean corpuscular hemoglobin concentration 
MCV  
 
mean corpuscular volume 
MDMA 
 
3,4-methylenedioxymethamphetamine 
MEQ30 
 
Mystical experience questionnaire 30 items 
MINI  
 
Mini International Neuropsychiatric Interview 
Ml 
 
 
milliliter 
MM-120 
 
Mind Medicine, Inc. compound dose for D-lysergic acid diethylamide D- 
 
 
 
tartrate 
PK 
 
 
Pharmacokinetic 
PV 
 
 
Pharmacovigilance 
QTcF  
 
QT interval corrected using Fridericia’s formula 
RDW  
 
red cell distribution width 
RR 
 
 
respiratory rate 
SAE 
 
 
Serious adverse events 
SNDRI  
 
serotonin-norepinephrine-dopamine reuptake inhibitor 
SNRI  
 
selective serotonin reuptake inhibitor 
SSRI 
 
 
selective serotonin reuptake inhibitor 
SUSAR 
 
Unexpected serious adverse reaction 
T1/2 
 
 
half-life 
TCA 
 
 
tricyclic antidepressant 
TdP 
 
 
Torsades de pointes 
THC 
 
 
tetrahydrocannabidiol 
TIA 
 
 
transient ischemic attack 
Tmax  
 
time of peak plasma concentration 
ULN 
 
 
Upper limit of normal 
VAS 
 
 
Visual analog scale 
WHO  
 
World Health Organization 
WOCBP 
 
women of childbearing potential 
β-HCG  
 
beta human chorionic gonadotropin 
 


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1. INTRODUCTION 
1.1 Disease Background 
Attention-deﬁcit/hyperactivity disorder (ADHD) is a chronic neuropsychiatric disorder, 
affecting about 5% of adults (Kessler et al., 2006). The disease is deﬁned in Diagnostic and 
Statistical Manual of Mental Disorders, 5th ed. (DSM-5) by symptoms of inattention, 
hyperactivity, and impulsivity, resulting in signiﬁcant impairment. When compared to the 
general public, individuals with adult ADHD have increased rates of psychiatric 
comorbidities, underemployment and unemployment, substance abuse disorders, divorce 
and marital separation, and motor vehicle accidents (Biederman et al., 2006a; Biederman 
et al., 2006b; Eakin et al., 2004; Wilens et al., 2004). Nonetheless, adult ADHD remains 
signiﬁcantly under-diagnosed and under-treated, at rates of only 10%-25% affected adults 
receiving a proper diagnosis and less than 25% receiving proper treatment (Castle et al., 
2007; Kessler et al., 2005; Kessler et al., 2006). 
Medical management of ADHD entails the use of stimulants - methylphenidate (Ritalin), 
dextroamphetamine (Dexedrine), methamphetamine (Desoxyn), as well as an 
amphetamine-dextroamphetamine combination (Adderall). Several subjects experience 
adverse effects that can result in discontinuation (Gajria et al., 2014), some subjects are 
reluctant to take medication (Matheson et al., 2013), or respond insufficiently to stimulants 
and experience residual symptoms (Wigal, 2009), and long-term beneficial effects have not 
been convincingly established (Moriyama et al., 2013). Therefore, new medications are 
needed to treat ADHD. 
1.2 Drug Background 
Lysergic acid diethylamide (LSD) is a prototypical classic hallucinogen (Nichols, 2004; 
Passie et al., 2008) which was first synthesized by the Sandoz chemist Albert Hofmann 
who also discovered its psychotropic effects (Hofmann, 1979). In the 1950s to 1970s, LSD 
was initially used as an experimental tool (“psychotomimetic”) to study psychotic-like 
states and model psychosis (Bercel et al., 1956; Koelle, 1958), and as an adjunct in 
“psycholytic (substance-assisted) psychotherapy”. LSD became one of the best studied 
substances with several thousands of early scientific reports (Hintzen et al., 2010; Nichols, 
2004; Nichols, 2016; Passie et al., 2008). LSD has also been investigated for the treatment 
of alcoholism (Krebs et al., 2012), addiction (Savage et al., 1973), anxiety associated with 
terminal illness (Gasser, 2012b; Gasser et al., 2014; Grof et al., 1973; Pahnke et al., 1969), 
depression (Passie et al., 2008) and different manifestations of headache (Schindler et al., 
2015; Sewell et al., 2006). Clinical research with LSD ended in the 1970s due to regulatory 
restrictions but its use for personal and recreational purposes continued. It is estimated that 
38 million US people or 15% over the age of 12 years ingested a hallucinogen once in their 
lifetime (Johnston et al., 2016; Krebs et al., 2013a). In Europe, the lifetime prevalence of 
LSD use among young adults is estimated to be in the range of 6-8% (EMCDDA, 2016). 
Thus, a significant proportion of the western society is familiar with the effects of this 
substance. LSD is not associated with compulsive drug seeking (addiction), and there are 
relatively few medical emergencies and adverse effect (Nichols, 2016). Use of LSD or 
psilocybin is not associated with mental health problems and may even be protective 
(Johansen et al., 2015; Krebs et al., 2013b). In a safe setting, no drug-related severe adverse 
effects have been observed after administration of LSD in healthy subjects and subjects 
(Carhart-Harris et al., 2015; Dolder et al., 2016; Gasser, 2012b; Gasser et al., 2014; Schmid 
et al., 2015). The main adverse effects are due to the psychotropic effects of LSD at high 


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doses (particularly 70 μg) when used in illicit and non-medical environment settings. 
Recently, the medical value of hallucinogens has again been studied in several clinical trials 
(Baumeister et al., 2014; Bogenschutz et al., 2015; Davenport, 2016; Gasser et al., 2014; 
Gasser et al., 2015; Grob et al., 2011; Johnson et al., 2014; Kupferschmidt, 2014; Nichols, 
2016). 
1.3 Rationale for Investigating Repeated Low-dose LSD 
Administration in Subjects with ADHD 
There is a growing interest in the use of psychedelic substances for health-related purposes, 
including symptom relief for disorders like anxiety, depression, and pain (Nichols et al., 
2017). Although recent clinical trials have focused on the use of experiential doses of these 
substances, anecdotal evidence supports the potential therapeutic utility of lower doses of 
psychedelic substances in reducing symptomatology of a range of mental and physiological 
disorders (Anderson et al., 2019a; Anderson et al., 2019b; Fadiman et al., 2019; Hutten et 
al., 2019a; Hutten et al., 2019b; Lea et al., 2020; Passie, 2019; Polito et al., 2019; 
Prochazkova et al., 2018). The internet has a number of surveys, chat rooms and coaches 
touting the benefits of psychedelics, particularly LSD at sub-perceptual doses to treat 
ADHD, anxiety, and depression. It has yet to be shown whether a psychedelic experience 
as induced by a “full” regular dose is necessary to produce symptom relief, or whether 
(repeated) sub-perceptual doses have therapeutic potential as well. 
Recently repeated low dosing, the practice of repeatedly using sub-experiential doses of 
psychedelics like LSD and psilocybin (Kuypers et al., 2019; Passie, 2019), has gained 
considerable media attention, where it is portrayed as a performance enhancing activity 
(Hutten et al., 2019b), and as a treatment for certain diseases like depression, anxiety and 
ADHD. In contrast to a typical recreational dose (approximately 100 μg) that is 
characterized by significant perceptual changes, a repeated low dose (approximately 10 to 
20 μg) does not induce perceptual alterations such as visual distortion or synesthesia 
(Bershad et al., 2019; Family et al., 2020; Kuypers et al., 2019; Passie, 2019). The most 
widely suggested practice for repeated low dosing is taking one-tenth of a regular, 
recreational dose of a psychedelic once every three days (Fadiman et al., 2019; Kuypers et 
al., 2019; Passie, 2019). 
Clinical evidence from controlled studies regarding the efficacy of repeated low dosing 
psychedelics for symptomatic relief is lacking. However, recent surveys have suggested 
that there are potential benefits of repeated low dosing LSD. Specifically, repeated low 
dosing psychedelics was rated more effective than conventional therapies for the treatment 
of ADHD by persons using psychedelics (Hutten et al., 2019b). Users mostly report 
repeated low dosing psychedelics for performance enhancement (Hutten et al., 2019a; Lea 
et al., 2019; Lea et al., 2020) and to improve mental health (Lea et al., 2019; Lea et al., 
2020). Other reasons are mood enhancement and symptom relief, curiosity, and enhancing 
empathy (Hutten et al., 2019a). Taken together, that survey data indicate that people low 
dose as self-medication therapy for mental health as alternative or adjunct to conventional 
therapy (Lea et al., 2020). Adverse effects of low dosing include stronger-than-expected 
psychedelic effects, anxiety, and physical adverse effects (Lea et al., 2020). Other perceived 
limitations include issues related to dosing, taking illegal substances, limited or no mental 
health or cognitive improvement, unpleasant “off” days, only short-term benefits, and 
concerns about dependence and drug-related risks (Lea et al., 2019). Large other non-
published survey data also indicate that people low dose to enhance mood, creativity, focus, 


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and sociability. There are no controlled data on either the efficacy or adverse effects of 
repeated low dosing psychedelics, including LSD.  
Therefore, the present study aims to investigate the effectiveness of repeated low dosing 
with LSD for treatment of ADHD in line with a common anecdotal practice. There are no 
scientific data to inform a possible mechanism of action for how LSD may improve ADHD 
symptoms. The rationale to test LSD in ADHD subjects is based on anecdotal evidence of 
efficacy. The same dose will then be administered twice weekly and effects on symptoms 
of ADHD in adults will be compared with placebo in a double-blind manner over 6 weeks.  
1.4 Study Drug 
1.4.1. Pharmacology of LSD 
LSD is a very potent partial 5-HT2A receptor agonist (Nichols, 2016; Rickli et al., 2016). 
LSD also stimulates 5-HT1 receptors, adrenergic α1 receptors and dopaminergic D1-3 
receptors (Rickli et al., 2015; Rickli et al., 2016). However, these receptor interactions are 
considered less relevant for the psychotropic action of LSD (Nichols, 2016; Preller et al., 
2017) or other psychedelics. The subjective effects of psychedelics are generally considered 
to be mediated primarily by activation of the 5-HT2A receptor (Kraehenmann et al., 2017b; 
Preller et al., 2017; Vollenweider et al., 1998; Nichols, 2016). 
1.4.2. Clinical pharmacology: Pharmacokinetics of LSD 
LSD is well-absorbed after oral administration with an estimated oral bioavailability of 70-
100%. LSD is metabolized to the inactive metabolite O-H-LSD (Dolder et al., 2017b; Holze 
et al., 2019; Luethi et al., 2019; Steuer et al., 2017). There are no active metabolites of LSD 
reaching relevant plasma concentration to be active in vivo (Dolder et al., 2017b; Holze et 
al., 2019; Luethi et al., 2019; Steuer et al., 2017). After acute administration of LSD, peak 
plasma concentration of LSD is reached at 1-3 h. The plasma elimination half- life of LSD 
is approximately 3 h (Dolder et al., 2017b; Holze et al., 2019, Holze et al., 2021b). At doses 
of LSD of 100-200 μg, LSD is almost completely eliminated from the body within 12-24 h 
(Dolder et al., 2017b; Holze et al., 2019). 24 hours after the administration LSD up to 
200 μg, no LSD could be detected in the urine (Dolder et al., 2015a; Dolder et al., 2015b). 
The pharmacokinetics of low doses of 5-20 μg LSD have also been investigated in 20 
healthy subjects (Holze et al., 2021a) . After administration of 20 μg of LSD (the dose to 
be used in the present study), peak plasma concentrations were reached at (geometric mean 
and range) 1.1 h (0.2-2.4). The elimination half-life was 2.9 h (1.6-2.4). 
1.4.3. Clinical pharmacology: Pharmacodynamics - psychological and 
physiological effects of LSD 
LSD produces dose-dependent marked acute subjective (psychedelic) effects and weak 
autonomic system stimulation. Subjective effects parallel the LSD plasma concentration-
time curves. The acute pharmacodynamic effects of LSD dose-dependently peak at 2 to 3 h 
and gradually subside, lasting up to 9 and 12 h after administration of high doses of 100 
and 200 μg, respectively (Dolder et al., 2015b; Dolder et al., 2016; Dolder et al., 2017b; 
Holze et al., 2019; Schmid et al., 2015). The pharmacodynamics of low doses of 5-20 μg 
LSD have also been investigated (Holze et al., 2021a). The dose of 20 μg, which is the dose 
to be used in the present study, produced subjective drug effects starting after 0.7 h (0.04-
1.3), reaching a maximum effect at 2.3 h (1.2-4.6), and lasting for 6 h. The maximum 
subjective response (any subjective drug effect) reached 3.6 on a scale from 0-10. 


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Alterations of the mind as measured as subjectively rated on the 5D-ASC scale reached 
blissful state scores of 5-10%, and anxiety scores of < 3% of the scale maxima, indicating 
very weak acute effects of LSD at this dose (Holze et al., 2021a). A dose of 20 μg LSD 
base did not relevantly change blood pressure or heart rate (Holze et al., 2021a). Other 
placebo-controlled studies in healthy subjects similarly reported weak acute drug effects of 
LSD at low doses. A study using single doses of 5-20 μg of LSD tartrate reported a 
statistically significant and small subjective drug effect (Yanakieva et al., 2019). Low doses 
of LSD of 5-20 μg tartrate did not significantly alter self-ratings of perceptual distortion 
and subjective concentration, but there were trends toward impairments (Yanakieva et al., 
2019). A study using LSD tartrate in doses of 6.5-26 μg reported acute increases in ratings 
of feel drug, like drug, vigor and produced no alteration of cognition of physiological 
measures (Bershad et al., 2019). On the 5D-ASC, the 26 μg LSD dose increased ratings of 
blissful state and anxiety to approximately 15 and 3% (maximum 100%), respectively 
(Bershad et al., 2019). Furthermore, effects of 25 μg LSD were assessed in 16 healthy 
subjects. A dose of 25 μg of LSD produced weak subjective drug effects (ratings of 
approximately 15% on a 0-100% scale) that were significantly different from placebo. 
Mean peak responses were 32% and 2% for good and bad drug effects, respectively. On 
the 5D-ASC, mean ratings of blissful state and anxiety were 6 and 0% (scale maximum: 
100%), respectively. The mean effect duration was 7 h (data on file). The dose was 
distinguished from placebo by most participants. In all the studies discussed above there 
were no relevant subjective bad drug effects and no relevant adverse reactions. Taken 
together, available evidence from similar controlled studies suggests that LSD at a dose of 
20 μg will produce potentially noticeable but very weak acute positive subjective effects 
lasting for approximately 6 hours. While LSD moderately increases blood pressure, heart 
rate and body temperature at high doses (Dolder et al., 2017a; Dolder et al., 2017b; Holze 
et al., 2019; Holze et al., 2020; Schmid et al., 2015), no clinically relevant cardiostimulant 
effects are expected at a dose of 20 μg (Holze et al., 2021a). 
1.5 Recent and Current Clinical Studies with LSD in Healthy Subjects 
and Subjects 
LSD was extensively investigated in humans in the 1950s and 1960s. Clinical research with 
LSD ended in the 1970s due to regulatory restrictions, but its use for personal and 
recreational purposes continued. In recent years, there has been a renewed interest in the 
research of hallucinogens under laboratory conditions (Carhart-Harris et al., 2015; Dolder 
et al., 2016; Liechti, 2017; Nichols, 2004; Nichols, 2016; Passie et al., 2014; Schmid et al., 
2015; Terhune et al., 2016), and the use of hallucinogenic drugs such as psilocybin and 
LSD as treatment for depression (Carhart-Harris et al., 2017; Carhart-Harris et al., 2016a), 
anxiety associated with life-threatening diseases (Gasser, 2012b; Gasser et al., 2014), and 
substance disorders (Johnson et al., 2016; Krebs et al., 2012). LSD is currently being 
investigated in several research groups in healthy subjects and subjects. Most of the recent 
research on LSD was conducted or is being conducted by Liechti et al. at the University 
Hospital Basel (Dolder et al., 2018; Dolder et al., 2016; Holze et al., 2019; Holze et al., 
2020; Liechti, 2017; Liechti et al., 2017; Luethi et al., 2019; Mueller et al., 2017a; Mueller 
et al., 2017b; Muller et al., 2018; Schmid et al., 2015; Schmid et al., 2018; Schmidt et al., 
2017; Strajhar et al., 2016). Additionally, a study using singly dose administration of small 
doses of LSD, similar to the present study but in healthy volunteers, has been completed by 
Kuypers et al. at the University of Maastricht (Holze et al., 2021a; Hutten et al., 2020a; 
Hutten et al., 2020b; Ramaekers et al., 2020), and a study using multiple dose 
administration of small doses is ongoing. The single dose administration study documented 
the pharmacokinetics and effect-profile for microdoses of LSD (Holze et al., 2021a; Hutten 


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et al., 2020b), an increase in circulating brain-derived neurotrophic factor (BDNF) (Hutten 
et al., 2020a), and found beneficial effects on experimentally induced pain (Ramaekers et 
al., 2020). Furthermore, clinical trials are currently being conducted in Switzerland in 
subjects with anxiety disorder, major depression, and cluster headache using the same 
product to be used in the present study, but at higher doses (clinicaltrials.gov: 
NCT03781128, NCT03866252, and NCT03153579). 
The University Hospital Basel completed several double-blind, placebo-controlled, 
random-order cross-over Phase 1 studies in healthy subjects. The first study 
(clinicaltrials.gov: NCT01878942) used a dose of 200 μg oral LSD in 16 subjects (8 male, 
8 female), and characterized the psychological, physiological, endocrine, and 
pharmacokinetic effects of LSD (Dolder et al., 2015b; Dolder et al., 2016; Schmid et al., 
2015; Strajhar et al., 2016). Administration of LSD produced pronounced alterations in 
waking consciousness that lasted up to 12 hours. The predominant effects induced by LSD 
included visual hallucinations, audiovisual synesthesia, and positively experienced 
derealization and depersonalization phenomena. Subjective well-being, happiness, 
closeness to others, openness, and trust were increased by LSD. LSD also increased blood 
pressure, heart rate, and body temperature. Adverse effects produced by LSD completely 
subsided within 72 hours, and no severe acute adverse effects were observed (Schmid et 
al., 2015). No sex differences could be shown. The acute subjective and sympathomimetic 
responses to LSD were closely associated with the concentrations in plasma over time, and 
exhibited no acute tolerance (Dolder et al., 2015b). In the second study (clinicaltrials.gov: 
NCT02308969), effects of a single dose of LSD of 100 μg on brain activation (fMRI) were 
investigated in 24 healthy subjects (Dolder et al., 2016; Mueller et al., 2017a; Mueller et 
al., 2017b; Schmidt et al., 2017). At the 100 μg dose, LSD induced lower ratings for blissful 
state, insightfulness, and changed meaning of percepts compared with the 200 μg dose. 
LSD also produced lower visual analog scale (VAS) ratings of good drug effects, closeness 
to others, openness, trust, bad drug effects and anxiety than the higher dose (Dolder et al., 
2016). Changes in vital signs such as blood pressure, heart rate, body temperature, and pupil 
size or acute adverse effects were all similar and relatively moderate at the 100 and the 
200 μg dose. Taken together, the lower 100 μg dose of LSD did not produce a similarly 
strong LSD response with regards to the subjective effects. LSD decreased amygdala 
reactivity to fearful stimuli (Mueller et al., 2017a), enhanced thalomocortical functional 
connectivity (Mueller et al., 2017b), and enhanced connectivity between normally more 
functionally separated resting state networks (Muller et al., 2018). LSD also produced long-
lasting effects (Carhart-Harris et al., 2016b; Schmid et al., 2018). LSD increased optimism 
and trait openness at two weeks compared with placebo in a study conducted at Imperial 
College London (Carhart-Harris et al., 2016b). One year after LSD administration, 
significant and persisting increases in positive attitudes, positive mood changes, positive 
social effects, positive behavioral changes, and in well-being/life satisfaction could be 
observed, which were subjectively attributed to the LSD experience (Schmid et al., 2018). 
No changes in negative attitudes, negative mood, antisocial/negative social effects, or 
negative behavior were attributed to the LSD experience (Schmid et al., 2018). None of the 
participants reported any psychological problems or perceptual changes (e.g., flashbacks) 
up to 1 month after the LSD session, and no adverse effects were reported spontaneously 
up to 12 months following LSD administration (Schmid et al., 2018). 5D-ASC total scores, 
reflecting acutely induced alterations in consciousness, and MEQ total scores correlated 
with changes in well-being/life satisfaction 12 months after LSD administration (Schmid 
et al., 2018). The data indicate that in healthy subjects, psychedelics increased openness 
and psychological well-being mid- to long-term, possibly related to the hallucinogen-


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induced profound alterations of consciousness and mystical-type experiences (Carhart-
Harris et al., 2016b; Griffiths et al., 2008; MacLean et al., 2011; Schmid et al., 2018). 
Consistently, there is no evidence of psychological or psychiatric problems associated with 
the use of psychedelic substances by healthy subjects according to follow-up data from 
placebo- controlled studies (Carhart-Harris et al., 2016b; Schmid et al., 2018; Studerus et 
al., 2011) or epidemiological data (Johansen et al., 2015; Krebs et al., 2013b). 
A recently completed study (Holze et al., 2021b) assessed the role of the 5-HT2A-receptor 
in LSD-induced altered states of consciousness (EKNZ 2017-01348), using different doses 
of LSD (25, 50, 100, and 200 μg) with a pre-treatment with the 5-HT2A-receptor antagonist 
ketanserin for the LSD 200 μg dose. Ketanserin pre-treatment reduced the response to 
200 μg LSD to that of 25 μg of LSD alone indicating a key role of the 5-HT2A-receptor in 
the mediation of the acute psychedelic effects of LSD, and confirming a previous study 
conducted in Zurich Switzerland (Preller et al., 2018; Preller et al., 2017; Preller et al., 
2019). The study also described the dose-response of LSD in the 25-200 μg dose range 
(Holze et al., 2021b). Furthermore, a recently published study compared the acute effects 
of LSD (100 µg) with those of other psychoactive substances such as the prototypical 
stimulant D-amphetamine and the prototypical entactogen/empathogen MDMA (Holze et 
al., 2020). LSD induced significantly higher ratings on the 5D-ASC and MEQ scale than 
MDMA and D-amphetamine. LSD also produced greater subjective drug effects, ego 
dissolution, introversion, emotional excitation, anxiety, and inactivity than MDMA and D-
amphetamine. It also induced greater impairments in concentration, sense of time, and 
speed of thinking compared with MDMA and D-amphetamine (Holze et al., 2020). 
In collaboration with psychiatrists, an ongoing study investigated effects of LSD-assisted 
psychotherapy in subjects suffering from anxiety symptoms in severe diseases or in 
psychiatric anxiety disorders (EKNZ 2016- 00992, clinicaltrials.gov: NCT03153579). A 
clinical Phase 2, double-blind, placebo-controlled pilot study previously compared LSD- 
and placebo-assisted psychotherapy in subjects suffering from anxiety associated with 
advanced-stage life- threatening diseases (Gasser et al., 2014; Gasser et al., 2015). In this 
study, twelve subjects were included and eight received 200 μg of LSD twice in two 
sessions 2-3 weeks apart, and three subjects received placebo (a low dose of LSD of 20 μg). 
The study documented a significant decrease in anxiety 2 months after the two LSD 
sessions compared with baseline anxiety scores, whereas State-Trait Anxiety Inventory 
(STAI) scores did not decrease after the placebo sessions. The study also documented 
sustained decreases in anxiety up to 12 months after the LSD treatments (Gasser et al., 
2015). Additionally, LSD markedly reduced the number of migraine attacks in two 
migraine subjects in this study (Gasser et al., 2014). There were no drug-related severe 
adverse effects, no panic reactions, or other medical or psychiatric complications. As a 
consequence of this pilot study in subjects and previous evidence, the use of LSD in 
combination with psychotherapy was re-started (after similar activity in the 1980-90s 
(Gasser, 1996)) in Switzerland with the authorization of the Swiss Federal Office of Public 
Health (BAG). Currently, LSD is being used in selected subjects (“compassionate use”) in 
Switzerland, mainly in those with anxiety, depression, compulsive disorder, cluster 
headache, and migraine (Schmid et al., 2021). 
In Zurich, Vollenweider and colleagues conducted a double-blind, placebo-controlled, 
cross-over study using a dose of 100 μg oral LSD in 25 healthy participants (Kraehenmann 
et al., 2017a; Kraehenmann et al., 2017b; Preller et al., 2017). The study included two 
administrations of LSD in the same participant, 100 μg LSD alone, and 100 μg LSD 


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combined with ketanserin (40 μg orally). All effects of LSD were blocked by ketanserin 
(Kraehenmann et al., 2017a; Kraehenmann et al., 2017b; Preller et al., 2017) indicating a 
mediating role for the 5-HT2A- receptor, as previously shown for psilocybin (Vollenweider 
et al., 1998). 
In London, Carhart-Harris and colleagues performed an experimental single-blind, within-
subject, placebo-controlled pilot study in 10 healthy volunteers using 40-80 μg LSD 
administered intravenously (Carhart- Harris et al., 2015; Kaelen et al., 2015). The same 
group also conducted another larger placebo-controlled cross-over study in 20 subjects, 
using a dose of 75 μg LSD (intravenously, corresponding to about 100 μg oral LSD) 
(Carhart-Harris et al., 2016b; Carhart-Harris et al., 2016c; Kaelen et al., 2016; Lebedev et 
al., 2016; Roseman et al., 2016; Speth et al., 2016; Tagliazucchi et al., 2016). LSD produced 
heightened mood, a blissful state, and also acute psychosis-like symptoms including 
thought disorder, delusional thinking and paranoia. There was only a small increase in 
anxiety, significantly smaller than the blissful experience. Overall, there was a bias towards 
positive affect. At two weeks, there was no effect on delusional thinking, and a trend 
towards less distress and less preoccupation with delusional thoughts (Carhart-Harris et al., 
2016b). These recent experimental studies are expected to provide insight into the 
mechanisms of action of psychedelics that may contribute to their therapeutic potential 
(Liechti, 2017). 
Eleusis Benefit Corporation, in collaboration with researchers in the UK, conducted a 
clinical trial in older healthy adults aged 55-75 years using small single doses of LSD of 5-
20 μg that were repeatedly administered every fourth day over a 21-day period. LSD did 
not produce relevant alterations of perception or concentration. LSD was well tolerated, 
and the frequency of adverse events was no higher than for placebo. Assessments of 
cognition, balance, and proprioception revealed no impairment (Family et al., 2020; 
Yanakieva et al., 2019). In terms of dosing schedule, this published study (Family et al., 
2020; Yanakieva et al., 2019) and a multiple dose administration study currently conducted 
in Maastricht are the most similar to the present one. Both studies support the safety of the 
current dosing approach. 
2. STUDY OBJECTIVES 
2.1 Primary Objective 
To assess the treatment efficacy vs placebo of repeated low doses (20 μg) of MM-120 for 
six weeks in adult subjects with ADHD measured by Adult Attention Deficit Investigator 
Symptom Rating Scale (AISRS). 
2.2 Secondary Objectives 
● To assess treatment efficacy vs placebo measured by change from baseline in AISRS 
after 1 week of treatment. 
● To assess treatment efficacy vs placebo based on the proportion of subjects who 
experience at least a 1-point decrease in the Clinical Global Impression - Severity of 
Illness Scale (CGI-S). 
● To assess treatment efficacy vs placebo measured by change from baseline in CGI-S. 
● To assess the safety and tolerability by AE and SAE assessment. 


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3. STUDY PLAN AND PROCEDURES 
3.1 Overall Study Design 
This study is a multi-center, randomized, double-blind, placebo-controlled Phase 2a study 
of low dose MM-120 (20 μg) compared with a placebo administered for 6 weeks (twice a 
week). 
There will be a 1:1 randomization, double-blind, to MM-120 or placebo of 52 adults with 
ADHD with the aim to reach 26 evaluable subjects in each of the 2 arms at Week 6. 
There will be 2 arms: 
● Arm 1-Placebo: a total of 26 subjects will receive a placebo identical in appearance to 
the IMP administered orally twice weekly for 6 weeks. Subjects and site staff will 
remain blinded to the treatment arm. 
● Arm 2-MM-120: a total of 26 subjects will receive 20 μg of MM-120 twice weekly for 
6 weeks. Subjects and site staff will remain blinded to the treatment arm. 
Subjects will be evaluated at Baseline, Week 1, Week 6, and Week 10 (follow-up) for 
AISRS and CGIS by a trained study personnel; the primary endpoint will be based on 
evaluation of AISRS at Baseline and at Week 6, with a key secondary endpoint after 1 week 
of treatment.  
Subjects are free to discontinue the study at any time without providing a reason. However, 
the Investigator should try to identify the reason and document in the eCRF. 
Specific reasons for discontinuing from the study should be documented in the eCRF, and 
include, but are not limited to: 
● Subject’s decision   
● The Investigator or Sponsor judges that it is in the best interest of the subject to stop 
study treatment due to any abnormality compromising subject safety 
● Pregnancy 
● Severe noncompliance to the study protocol as judged by the Investigator and/or the 
Sponsor. 
Subjects who prematurely discontinue may be replaced, per Sponsor decision. Subjects will 
not be allowed to re-enter the study. 
The study will stop enrolling subjects once 26 subjects per arm are randomized, or if the 
Investigator or the Sponsor judges that it is in the best interest of the subjects to stop study 
enrollment due to low accrual or safety or other reason. Subjects who have given informed 
consent and have not yet been excluded, completed, or terminated from the study will be 
allowed to continue in the study. An evaluable subject is defined as a randomized subject 
(as defined in the Statistical Analysis Plan [SAP]).  
3.1.1. Screening and Baseline visits 
Potential study subjects who provide informed consent will have 
eligibility evaluated/confirmed at 2 visits: 1) Screening, and 2) 
Baseline. The screening visit occurs up to 4 weeks prior to 




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symptoms of inattention, and 9 items that address symptoms of impulsivity and 
hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 
54. A higher score corresponds to a worse severity of ADHD. 
3.2.2. Secondary Endpoints 
ADHD related endpoints 
● Key secondary endpoint: change from baseline in AISRS after 1 week (2 doses) of 
treatment  
● Occurrence of subjects who experience at least a 1-point decrease in the CGI-S 
● Change from baseline in CGI-S after 1 week and 6 weeks of treatment 
● Change from baseline in subject self-assessment by the Adult ADHD Self-Report Scale 
(ASRS) and Connors’ Adult ADHD Rating Scale (CAARS). 
Safety endpoints 
● Vital signs (supine blood pressure, body temperature, heart rate, respiratory rate)  
● 12-lead safety ECG 
● Adverse events (e.g., psychological and/or physiological adverse events)  
● Columbia-Suicide Severity Rating Scale (C-SSRS) 
● Safety laboratory evaluation and Urine pregnancy testing 
Pharmacokinetic endpoints 
● Blood samples for PK evaluation will be collected for 6 hours after the administration 
of the IMP on day 1.  
● Cmax 
● Tmax 
● AUC 
● T1/2 
Acute effects (Pharmacodynamic) endpoints 
● 5 Dimensions of Altered States of Consciousness scale (5D-ASC),  
● Mystical Experience Questionnaire (MEQ), drug effect Visual Analog Scale (VAS) 
3.2.3. Exploratory Endpoints 
● Sleep quality/ duration rating will be evaluated based on daily diary entries and details 
of the analysis will be included in the SAP. 
4. SUBJECT SELECTION CRITERIA 
The Investigator should keep a record (i.e., screening log) of subjects who were screened. 
Each subject must meet all the inclusion criteria and none of the exclusion criteria for this 
study at the time of randomization. Under no circumstances can there be exceptions to this 
rule. A repeat test may be allowed in the screening period with the Sponsor’s medical 
monitor approval, with the exception of the AISRS and CGI-S, which can only be assessed 
once at screening for eligibility purpose.  


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4.1 Inclusion Criteria 
All inclusion criteria will be based on the medical judgment of the Investigator. For 
inclusion in the study, subjects must meet all the following criteria: 
1. Ability and willingness to provide written, informed consent prior to initiation of any 
study-related 
procedures 
and 
to 
adhere 
to 
all 
study 
requirements. 
NOTE: The subject (i.e., not a legally authorized representative) must be cognitively 
able to understand the requirements of the study and provide the informed consent. 
2. Age ≥ 18 and ≤ 65 years at Screening.  
3. Subjects with the diagnosis of Diagnostic and Statistical Manual of Mental Disorders-
5 (DSM-5) ADHD, as determined by clinical evaluation and confirmed by structured 
interview (MINI).  
4. AISRS total score of ≥26 at screening. 
5. CGI-S score of ≥4 at screening. 
6. Must be willing to receive IMP dose twice weekly. On Day 1, the subject will come to 
the clinic and must be willing to take a taxi or public transportation home or be 
accompanied by a caregiver and not drive a car, use heavy equipment, or participate in 
any other dangerous activity for the remainder of the day after receiving IMP (NOTE: 
at any protocol visit after Day 1 dosing, dosing visits may occur at the subject’s home 
at the discretion of the PI, conducted by one of the study investigators or delegate and 
administered under supervision followed by the performance of the same procedures 
done at the clinic including safety monitoring. If early withdrawal is considered due to 
any safety issue identified, the Sponsor’s medical monitor should be notified. If a 
remote visit is conducted due to any reason related to the COVID-19 pandemic, 
notification must be sent to the Medical Monitor’s dedicated email address and Urgent 
Safety Measures as outlined in this protocol must be followed.) 
7. Must be willing to refrain from more than 6 standard alcoholic drinks per week 
(1 standard drink corresponds to 0.1 L wine, 0.3 L beer, or 4 cL liquor), more than 10 
cigarettes a day, and more than 2 cups of coffee a day throughout the study treatment 
period (6 weeks) and until the last study visit is complete (EoS or ET). 
4.2 Exclusion Criteria 
Subjects should not be included in the study if any of the following exclusion criteria are 
met: 
1. Past or present diagnosis of a primary psychotic disorder or first-degree relative with a 
psychotic disorder. 
2. Past or present bipolar disorder (DSM-5). 
3. Other current psychiatric disorders that, in the opinion of the Investigator or medical 
supervisor, may confound the results of the study (e.g., obsessive-compulsive disorder, 
dysthymic disorder, panic disorder, dissociative disorder, anorexia nervosa or bulimia 
nervosa). 
4. Subjects with 
 substance use 
disorder (except nicotine, provided subject does not smoke more than 
 a 
day). 
5. Somatic disorders including Central Nervous System (CNS) involvement of cancer, 
severe cardiovascular disease, untreated hypertension, severe liver disease (liver 


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enzyme increase by more than 3x the upper limit of normal except unconjugated 
hyperbilirubinemia due to Gilbert’s Disease, per Investigator), severely impaired renal 
function (estimated creatinine clearance < 50 mL/min by CKD-EPI formula), or 
anything else that, in the judgment of the Investigator or medical supervisor, poses too 
great a potential for side effects. 
6. Any lifetime history of suicide attempt; 
 
 suicidal thoughts or ideation (defined as a suicidal ideation score of 2 or 
greater in the Columbia-Suicide Severity Rating Scale [C-SSRS]); or endorsement of 
any suicidal behavior on the C-SSRS within 
 the screening 
visit. 
7. Likely to require psychiatric hospitalization during the course of the study. 
8. Once consent is signed, subject not willing or able to stop any prescription or non-
prescription ADHD medications during screening and prior to the baseline visit through 
final study visit (EoS or ET). A list of prohibited medications is provided in Appendix 
1. 
9. Plan to start, stop, or alter the use of any medications, supplements, or other therapeutics 
from Baseline until EoS or ET (see Appendix 1 for list of prohibited medications). 
10. Plan to start, stop or alter the use of psychotherapy, massage, meditation, acupuncture, 
hypnosis, yoga, or other similar therapy/activity from the time of providing informed 
consent until EoS or ET. 
11. 
 
 
12. Likely to need use of any psychiatric medications with the potential to confound 
interpretation of study results or impact safety, at the discretion of the Investigator, in 
the 10 weeks following Baseline up to EoS or ET (see Appendix 1 for list of prohibited 
medications). 
13. Use of investigational medication/treatment in the past 30 days prior to the screening 
visit. 
14. 
 
 
15. Clinically significant abnormal baseline laboratory values, VSs, and ECG that include 
the following: 
a. 
Have evidence of clinically significant hepatic disorder (e.g., alanine 
aminotransferase [ALT] or aspartate aminotransferase [AST] > 3X ULN 
(except for Gilbert’s disease), and  
b. 
Any clinically significant abnormal metabolic or hematologic screen, per 
Investigator or medical supervisor decision 
c. 
Exclusionary blood pressure: >140 mm Hg (systolic) or >90 mm Hg (diastolic); 
heart rate <45 beats/minute or >90 beats/minute after an approximately 5-
minute supine or semi-supine rest 
NOTE: If the first measurement of a subject’s heart rate is > 90 beats/minute, a 
second recording is allowed after an additional approximately 5-minute supine 
rest 
d. 
Exclusionary ECG parameters: QTcF > 450 msec (men), QTcF >470 msec 
(women) 
e. 
Any clinically significant abnormal electrocardiogram (ECG) finding (e.g., 
uncontrolled atrial fibrillation, ischemia) at Screening (Visit 1) or Baseline 


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(Visit 2), as determined by the Investigator or medical supervisor (in 
consultation with a cardiologist, if needed. 
16. Any other condition, therapy, laboratory abnormality, or other circumstance that, in the 
opinion of the Investigator or medical supervisor, may pose additional risk to the subject 
from participation in the study, may interfere with the subject’s ability to comply with 
study procedures, may make participation in the study not in the subject’s best interest 
or may confound the results of the study. 
17. Prior history or ongoing neuropsychiatric signs or symptoms associated with COVID-
19 such as development of, or current disorder, during or after a COVID-19 infection 
including anxiety, memory loss, confusion, depression, delirium, agitation, or 
psychosis.  
18. Women of childbearing potential (WOCBP) (i.e., physiologically capable of becoming 
pregnant) who are unwilling or unable to use a highly effective method of 
contraception, as defined in Appendix 2, for the duration of the study, OR Men 
physiologically capable of fathering a child who are sexually active with WOCBP but 
are unwilling or unable to use barrier contraception (e.g., condom with or without 
spermicidal cream or jelly) for the duration of the study.  
NOTE: See Appendix 2 for definitions of WOCBP and highly effective methods of 
contraception and for information about unacceptable methods of contraception. 
19. Women who are currently pregnant or breastfeeding or plan to become pregnant or 
breastfeed during the study. 
20. Men who plan to donate sperm during the study. 
21. Use of weight loss drugs 
 until the end of study. 
22. Subjects who are either unable or unwilling to consume alcohol in any amount 
(including due to religious or personal reasons). 
23. Subjects who have a change in AISRS score of ≥13-points 
between screening and baseline visits. 
5. STUDY CONDUCT 
5.1 Subject Enrolment and Randomization 
The Investigator will ensure: 
● Signed informed consent is obtained from each potential subject before any study 
specific procedures are performed. 
● The eligibility of each subject is determined, as described in Sections 4.1 and 4.2, 
before administering any IMP. 
Each screened subject will be identifiable by a unique screening number. The 
randomization number will be assigned to the subject on Day 1 before first dosing. 
This will be a double-blind study, with the random code generated by the study 
biostatistician, and provided to the GMP facility for packaging. The subject and 
Investigator will remain blinded to treatment assignment until the conclusion of the study 
unless it necessary to unblind the data for safety reasons. Only the GMP facility producing 
the IMP and the Principal Investigator (PI) at each site have access to the code (sealed 
envelopes). In case of a medical emergency, and in case of premature study termination, 
the code can be accessed by the PI. 


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In case of an emergency requiring immediate knowledge of the study treatment and 
appropriate management of the subject requires knowledge of treatment randomization, the 
treatment code may be broken by the Investigator. The Investigator should discuss the case 
with the Sponsor’s Medical Monitor immediately after breaking the treatment code.  
The Sponsor’s unblinded personnel may unblind treatment assignment for an individual 
subject’s SAE in order to fulfill expedited regulatory requirements. 
Changes that may be implemented, if needed, due to the coronavirus disease 2019 (COVID-
19) pandemic are described in Section 7.11 and a detailed impact will be included in the 
clinical study report (CSR). 
5.2 Procedures for Handling Incorrectly Randomized Subjects 
Subjects who fail to meet the inclusion/exclusion criteria should not, under any 
circumstances, be randomized into the study. There can be no exceptions to this rule. 
A subject who does not meet the eligibility criteria but who is randomized in error, and is 
identified before dosing, should be withdrawn from the study and another subject should 
be enrolled and receive the same treatment. 
Sponsor’s Medical Monitor should be notified if an ineligible subject is dosed. 
5.3 Treatments 
It is the Investigator’s responsibility to establish a system for handling the IMP, to ensure 
that: 
● Deliveries of such products are correctly received by a responsible person. 
● Deliveries are recorded and IMP is handled and stored safely and properly. 
● IMP provided for this study will be used only as directed in the study protocol. 
The study personnel will account for all IMP received at the site, dispensed to the subject, 
and returned to the pharmacy/site. Any discrepancies should be documented, investigated, 
and appropriately resolved. 
Any unused IMP are accounted for and returned to the IMP manufacturer (Basel), or 
destroyed by the hospital pharmacy of the research site. Receipt of the IMP and 
confirmation of destruction in writing will be obtained by each study site after study 
termination. 
5.4 Identity of Investigational Medicinal Product 
The drug substance is d-lysergic acid diethylamide (LSD). The identity of the IMP is 
presented below:  


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Table 1: Identity of Investigational Product 
IMP 
Dose 
MM-120 
LSD-tartrate 0.029mg (corresp. 0.020 mg LSD), ethanol 0.16 g, aqua pur ad 1 mL 
Placebo 
Ethanol 0.16 g aqua pur ad 1 mL 
Substance preparation and quality control: Analytically LSD d-tartrate salt will be obtained 
from
. LSD will be formulated as an oral drinking solution 
in dark vials. A Swissmedic approved Good Manufacturing Practice (GMP) facility 
(
) will prepare the IMP and the placebo (solution 
without MM-120 in identical vials), as well as perform the individualized packaging based 
on the randomization list, labeling and quality control (QC). 
5.4.1. Packaging and labelling 
The IMP will be packaged and labelled in accordance with current Good Manufacturing 
Practices (cGMPs) and provided to the sites. The shipping of the IMP to the sites will be in 
accordance with Good Distribution Practice (GDP). Re-supply will be executed as needed 
by the same manufacturer. 
Labelling of the IMP will be performed in accordance with cGMPs and will comply with 
the applicable laws and regulations of the countries in which the study sites are located. 
It is the responsibility of the Investigator to ensure that accurate accountability records are 
maintained throughout the study. 
5.5 IMP, Concomitant, and Post-Study Treatment(s) 
IMP will be administered twice a week, every 3 to 4 days. The IMP can be administered at 
the clinic on Day 1 or at home after Day 1 per PI decision under supervision of study 
personnel (i.e., the Investigator or delegate). Dosing/dispensing is based on the delegation 
log by authorized study personnel. The IMP cannot be provided to the subjects to take 
home. However, instead of administering the IMP at the clinic, IMP may also be brought 
to the subject’s home by one of the study investigators or delegates on the delegation log 
and administered at home. A supportive person of the subject’s choosing may be present 
with the subject in the home. Dosing at home is not allowed on Day 1 or if protocol 
procedures cannot be completed at the home visit or under urgent safety measures per 
Section 7.11. Furthermore, adverse effects and the use of concomitant medication are 
recorded based on the delegation log by authorized study personnel and the diary is 
checked; all safety assessments will be obtained and AEs recorded per Schedule of Events. 
Administration at home is mainly intended to facilitate trial conduct. If a remote visit is 
conducted due to any reason related to the COVID-19 pandemic, notification must be sent 
to the Medical Monitor’s dedicated email address and Urgent Safety Measures as outlined 
in this protocol must be followed. 
Apart from paracetamol/acetaminophen (not more than 3 g per day) if needed, no 
concomitant medication or therapy will be allowed that may interfere with the IMP (see 
Section 5.5.1). The subject should be instructed that no other medication is allowed, 
including herbal remedies, vitamins, mineral supplements, and over the counter products, 
without the consent of the Investigator. 


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The administration of all medication, (including the IMP), should be recorded in the 
appropriate sections of the eCRF. Treatment adherence will be assured by supervised 
administration of the IMP by the Investigator or delegate. The dose, time, and date of 
administration of the IMP will be recorded on the IMP accountability log and checked by 
the monitor at monitoring visits. Unused IMP should be destroyed at the site or returned to 
the manufacturer.  
5.5.1. Prohibited concomitant medications 
The use of medications, supplements, and other therapeutics (over the counter or 
prescribed) for treating attention-deficit/hyperactivity disorder (ADHD), anxiety, 
depression or mood disorders are prohibited from Day -1/Baseline (Visit 2) until End of 
Study or Early Termination (except if needed for care and treatment of the subject during 
the study per Investigator discretion). Additionally, the use of other substances, herbal 
treatments, etc. that may confound the results of the study are prohibited from Day -
1/Baseline (Visit 2) until End of Study or Early Termination. Subjects must also avoid 
starting, stopping, or altering non-medicinal therapies/activities from the time of providing 
informed consent until End of Study or Early Termination. Any prohibited substance(s) 
being taken at the time of signing consent at screening (Visit 1) should be tapered prior to 
Day -1/Baseline (Visit 2), if safe for the subject, in the opinion of the Investigator; tapering 
will be done with oversight from the Investigator or medical supervisor and in accordance 
with information provided in Appendix 1. A listing of specific restrictions for concomitant 
therapy use during the course of this study was provided, with any necessary washout 
periods or allowable conditions described. The subject must meet all eligibility criteria for 
which prohibited medication was prescribed, including but not limited to, psychotic 
disorder, bipolar disorder, or major depressive disorder with psychotic features OR any 
disorder that puts a subject at risk for a challenging experience, e.g., panic disorder. 
 
 
 
The table in Appendix 1 provides a listing of prohibited medications; however, it is not a 
comprehensive list of all restricted medications, supplements, and other therapeutics. 
Consult the Sponsor’s Medical Monitor or designee if there is any uncertainty regarding a 
subject’s use of a particular drug, drug class, supplement, or other therapeutic.  
Once an ICF is signed, subjects on prohibited medications, supplements, or other 
therapeutics may taper off that substance and participate in the study if the required washout 
conditions have been met. For prescribed medications to treat ADHD, anxiety, depression 
or other mood disorders, the medication taper will be overseen by the treating physician or 
a study physician based on acceptable local practice standards.  
 
 
 
 
 
 
 
 


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5.6 Withdrawal from Study 
Subjects may be withdrawn at any time. Once dosing has occurred, every attempt should 
be made to continue assessments to ensure the safety of the subject. Specific reasons for 
withdrawing a subject should be documented in the eCRF, and include, but are not limited 
to: 
●
Subject’s decision
●
The Investigator or Sponsor judges that it is in the best interest of the subject to stop
study treatment due to any abnormality compromising subject safety
●
Pregnancy
●
Severe noncompliance to the study protocol as judged by the Investigator and/or the
Sponsor.
Subjects who prematurely discontinue may be replaced, per Sponsor decision. Subjects 
will not be allowed to re-enter the study. 
5.6.1. Procedures for withdrawal of a subject from the study 
Subjects are free to withdraw their consent to participate in the study at any time, without 
prejudice. Such subjects will always be asked about the reason(s), and the presence of any 
adverse events. If possible, subjects who withdraw from the study after dosing and before 
completion should be seen by an Investigator, and undergo the assessments and procedures 
scheduled for the follow-up visit/end of study visit. Adverse events should be followed up. 
5.7 Audits and Inspections 
Authorized representatives of the Sponsor, Health Authority, or an Ethics Committee may 
perform audits or inspections at the site, including source data verification. The purpose of 
an audit or inspection is to examine all study-related activities and systematically and 
independently document, to determine whether these activities were conducted, and data 
were recorded, analyzed, and accurately reported according to the protocol, GCP, 
guidelines of the ICH, and any applicable regulatory requirements. The Investigator will 
contact the Sponsor immediately if contacted by a regulatory agency about an inspection at 
the center.






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Abbreviations:  5D-ASC = 5 dimensions of altered states of consciousness scale; AISRS = Adult ADHD Investigator Symptom Rating Scale; ASRS = Adult  
 
 
ADHD Self-Report Scale; BMI = body mass index; BP = blood pressure; CAARS = Conners’ Adult ADHD Rating Scale; CGI-S = Clinical Global 
 
 
Impression Scale; C-SSRS = Columbia-Suicide Severity Rating Scale; ECG = electrocardiogram; MEQ30 = Mystical Experience Questionnaire 
 
 
(30-item); VAS = Visual Analog Scale. 
 
* 
Twice weekly dosing will occur every 3 to 4 days (e.g., every Monday and Wednesday) with a ± 1 day window and will be coordinated to occur at the same 
 
time as the Week 2 visit and the every 2 weeks visits when possible. 
 
a 
Body mass index will be calculated using body height at screening. 
b 
Vital signs (pulse, BP, HR, RR, and body temperature) will be performed at every visit. 
c 
Clinical laboratory samples for chemistry and hematology and urine samples for drug screen and pregnancy testing will be collected pre-dose.  
d 
Pharmacodynamic scales are completed at home up to 6 hours after dosing. 
e 
Subject should be supine for 5 minutes prior to ECG collection. 
f 
CAARS-O-RS conducted at screening. All other assessments will be with the CAARS-L-SR. 
g 
Baseline visit is within 3 days of Day 1 (±1 day). 
h 
Following day 1 dosing, all visits may be conducted remotely per Investigator decision as long as all activities can be conducted per protocol, e.g., 
calibrated blood pressure cuff, calibrated weight scale, ECG, computer cognitive scale. Any visit conducted remotely due to COVID-19 requires Sponsor 
Medical Monitor and operations team notification and conduct under urgent safety measures and all protocol deviations captured in EDC designated 
COVID-19 deviation. 
 
X1 
subject fills out forms at home. 
 
 
X3 
6 weeks of blinded treatment on MM-120 / placebo; may be dosed at home per Investigator decision. 
X4 
2 hours after dosing. 
X5 
6 hours after dosing. 
X6 
Collected repeatedly 0-6 hours after dosing. 
X7 
PK samples will be collected at pre-dose, 0.5, 1, 2, 3, 4, and 6 hours post-dose. 
X8 
During treatment period, pregnancy testing will occur predose at each dosing visit or a minimum of once weekly.


Subjects excluded during screening may be rescreened once in consultation with the Sponsor’s 
Medical Monitor, when the reason for meeting an exclusion is likely to resolve (e.g., the subject 
had an exclusionary acute infection that is resolving, or a medication taper is taking longer than 
28 days). If a subject is rescreened, the subject must be reconsented to participate in the study. 
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6.2 Visits and Assessments 
All visits must be monitored for safety and AEs recorded. 
6.2.1. Screening visit 
Screening visits can be scheduled over the course of 4 weeks prior to the baseline visit. 
Study activities performed: 
Informed consent, 
, concomitant medication assessment, demography (age, 
sex, profession, level of education), medical/surgical history, inclusion/exclusion criteria check, 
MINI, pregnancy test, physical examination (including weight, height, calculated BMI, vital 
signs [body temperature, heart rate, supine BP, RR]), clinical laboratory tests, 12-lead ECG, 
AISRS and CGI-S, CAARS-O-RS, C-SSRS (Screening), and record adverse events. If eligible 
for participation, the subject is also given a diary at least 7 days prior to the scheduled baseline 
visit and instructed on its use. Subjects will be shown the cognitive performance tests and 
receive training in how to complete them at the Screening visit. 
6.2.2. Baseline (within 3 days of Day 1, [± 1 day]) 
The baseline visit (also called Day -1) should be the nearest day to the first day of dosing (i.e., 
Day 1). Because clinics may be closed on the weekends, a Friday visit is allowed for subjects 
whose Day 1 is on Monday.  
Study activities performed:  
 vital signs, cognitive performance tests, AISRS and CGI- S, ASRS and 
CAARS-L-SR, C-SSRS -SLV, record adverse events and concomitant medications, check daily 
diary. 
After completion of the study activities above, the inclusion/exclusion criteria are verified. 
6.2.3. Day 1 dosing (± 1 day) 
Randomization to MM-120 or placebo will occur before the first dose on Day 1. The first dose 
must be administered in the clinic. For this visit, the subject will remain at the testing facility 
for 6 hours after drug administration for blood sampling and getting familiar with the effects of 
LSD. 
Study activities performed before dosing: 
 vital signs, pregnancy test, C-SSRS (Since Last Visit), record adverse events 
and concomitant medications, check daily diary. 
Study activities performed after dosing: 


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Blood samples for PK are taken repeatedly at 0, 0.5, 1, 2, 3, 4, 6 hours after dosing. 
Pharmacodynamics are measured over 6 hours including subjective effects as assessed using 
VAS scales, blood pressure and heart rate. 12-lead ECG will be performed at 2 hours post 
dosing. The 5D-ASC and MEQ30 are assessed 6 hours after dosing.  
6.2.4. Post Day 1 dosing visits 
Following Day 1 dosing, all visits may be conducted remotely per Investigator decision as long 
as all activities can be conducted per protocol, e.g., calibrated blood pressure cuff, cognitive 
scale.  
Any visit conducted remotely due to COVID-19 requires Sponsor Medical Monitor and 
operations team notification and conduct under urgent safety measures and all protocol 
deviations captured in EDC designated COVID-19 deviation. 
The reason for a remote visit must be captured in the EDC. The site will choose one of the 
following reasons: 
1. COVID-19
2. Convenience for study subject
3. Site space considerations to conduct in clinic visits
4. Other
6.2.4.1 Week 2 visit 
At the first visit after 1 week of treatment (Day 8 or after), AISRS and CGI-S will be conducted 
in addition to other required study activities. These activities will be performed pre-dose on the 
3rd dosing visit. 
6.2.4.2 Twice weekly dosing 
Dosing (placebo/MM-120) must be completed by a trained study personnel with delegated 
authority for drug dispensing/ dosing. At each visit, adverse events and concomitant 
medications will be recorded, vital signs, C-SSRS (Since Last Visit) administered, and daily 
diary checked. Pregnancy testing will occur predose at each dosing visit or a minimum of once 
weekly. 
6.2.4.3 Every 2 weeks prior to first dose of the week 
At each visit that occurs every 2 weeks, clinical laboratory tests, ASRS and CAARS-L-SR, and 
pregnancy test will be conducted. 
 
 When combined with a dosing visit, regular activities scheduled to be 
conducted at each dosing visit will also be completed (see Section 6.2.4.2). 
6.2.4.4 Week 6 (last dose)  
Study activities performed before dosing: 
 C-SSRS (Since Last Visit), record adverse events and concomitant 
medications, check daily diary, physical examination (including weight, height, calculated 


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BMI, vital signs [body temperature, heart rate, supine BP, RR]), cognitive performance tests, 
clinical laboratory tests, ASRS and CAARS-L-SR, AISRS, and CGI-S.  
Study activities performed after dosing: 
12-lead ECG conducted at 2 hours post dosing. Pharmacodynamics using 5D-ASC and MEQ30
at 6 hours after dosing (subject completes at home).
6.2.5. Week 10 follow-up / End of Study or Early Termination (if subject 
withdraws before last follow-up visit [± 3 days]) 
The Week 10 follow-up visit may be conducted remotely per Investigator decision. The reason 
for conducting the visit remotely must be recorded in the EDC (as listed in Section 6.2.4), and 
if the reason is due to COVID-19, the Sponsor Medical Monitor and operations team must be 
notified and the visit conducted under urgent safety measures and all protocol deviations 
captured in the EDC. 
Pregnancy test, end of study physical examination (including weight, height, calculated BMI, 
vital signs [body temperature, heart rate, supine BP]), clinical laboratory tests, ASRS, CAARS-
L-SR, AISRS, CGI-S, C-SSRS (Since Last Visit) will be conducted at the last visit, adverse 
events and concomitant medications will be recorded, and daily diary checked. 
6.2.6. ADHD assessments 
6.2.6.1 Adult ADHD Investigator Symptom Rating Scale 
The Adult ADHD Investigator Symptom Rating Scale (AISRS) is a clinician-administered 
scale that assesses each of the DSM-5 symptoms of ADHD. The AISRS not only uses the adult 
ADHD prompts from the Adult ADHD Clinical Diagnostic Scale (ACDS) v1.2, but each of the 
stem questions are designed to better capture symptoms of the disorder as they present in 
adulthood. It has been used and validated many times in a variety of clinical drug trials. 
The AISRS total score consists of 18 items from the original ADHD-RS, which were derived 
based on DSM- 5 criteria for ADHD. The ADHD-RS includes 9 items that address symptoms 
of inattention, and 9 items that address symptoms of impulsivity and hyperactivity. Each item 
is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds 
to a worse severity of ADHD. 
6.2.6.2 Clinical Global Impression – Severity scale (Investigator Assessed) 
The Clinical Global Impression (CGI) rating scales are measures of symptom severity, 
treatment response, and the efficacy of treatments in treatment studies of subjects with ADHD. 
The scale has been validated. 
The Clinical Global Impression – Severity scale (CGI-S) is a 7-point scale that requires the 
clinician to rate the severity of the subject's illness at the time of assessment. Possible ratings 
are: 
●
normal, not at all ill


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●
borderline mentally ill
●
mildly ill
●
moderately ill
●
markedly ill
●
severely ill
●
among the most extremely ill subjects
The CGI-S is administered by a trained investigator. 
6.2.6.3 Adult Attention-Deficit/Hyperactivity Disorder Self-Reporting Rating Scale 
The Adult Attention-Deficit/Hyperactivity Disorder Self-Reporting Rating Scale (ASRS) was 
developed in conjunction with the World Health Organization (WHO), and the Workgroup on 
Adult ADHD. The ASRS has 18 questions, which are consistent with the DSM-5 criteria, and 
address ADHD symptoms in adults. The ASRS was externally validated on approximately 60 
adult subjects and showed high internal consistency and high concurrent validity with the 
physician administered ADHD rating system. Self-rating scales are generally useful tools 
because they create a way to collect a large, accurate amount of data in an organized, quick, 
and cost-effective way. 
It uses a scale that ranges from 0-4 based on the individuals mark in either "never, rarely, 
sometimes, often, very often" column for a possible total score of 72. Each column is used to 
describe the severity of the individual’s symptoms based on the question asked. The participant 
is asked to make a mark within one column for each question that best describes their answer. 
The questions are split up into 2 separate parts; Part A consists of questions 1-6, and Part B 
consists of questions 7-18. If four or more answers are scored “positive” then a high consistency 
of ADHD is indicated and further follow-up with a licensed clinician is necessary. Positive 
scores in Part B can be further identifying cues of the individual’s symptoms. 
There have been studies done to test the validity and reliability of the ASRS by comparing 
results of participants that were diagnosed with childhood ADHD, after completing the self-
reporting on their own, and then were subsequently tested with a clinician. There was a high 
correlation between the grouped symptoms (hyperactivity/impulsiveness and inattentiveness) 
when comparing the administration results of the tests. After an experiment with 60 adults 
whom completed the self-rating scale, and whose results were compared to their ratings with 
an administered ADHD rating scale, the results showed that the self-rating scale has a high 
internal reliability and also validity. 
6.2.6.4 Connors’ Adult ADHD Rating Scale 
The Connors’ Adult ADHD Rating Scale (CAARS) Self-Report Long Form (CAARS-L-SR) 
is a 66-item measure of ADHD symptoms that was designed as a self-report assessment for 
adult ADHD. Responses are scored on a 4-point scale, where 0 = not at all, 1 = just a little, 2 = 
pretty much, and 3 = very much. Test – retest reliabilities have been shown to be strong. The 
CAARS is highly correlated with other self-report ADHD measures, and initial studies on 
diagnostic accuracy for adult ADHD found the CAARS to have a good diagnostic sensitivity 


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and specificity relative to healthy controls. The Connors’ Adult ADHD Rating Scale Observer 
Short Screening (CAARS-S-OR) version will be used during screening. The 30-item version 
includes DSM-IV criteria for ADHD and takes approximately 10 min to complete. The scale 
yields scores for 1) inattentiveness, and 2) hyperactivity/impulsivity symptoms according to 
DSM-IV, and 3) an ADHD index which allows best to differentiate between persons with 
ADHD and normal persons. Item scores are summed to three main scores which are then 
transformed using population-derived age- and sex-adjusted norm values to a T-score. A T-
score < 60 indicates no ADHD. A T-score of 60-64 indicates borderline ADHD. A T-score of 
> 64 indicates ADHD.
6.2.7. Daily Diary 
To explore sleep quality and duration, the subjects will be given a home diary for recording 
sleep parameters. Details of the home diary will be described in a separate document. Analysis 
will be specified in the SAP.  
6.2.8. Cognitive Performance Tests (Computer Test) 
The cognitive performance tests are objective measurements of attention to a task(s). Tests are 
performed at Baseline and Week 6 (prior to last dose).  
6.2.8.1 Stop-signal task 
The stop-signal task requires subjects to make quick key responses to visually presented go 
signals, and to inhibit any response when a visual stop signal is presented (Fillmore et al., 2002; 
Kuypers et al., 2007). The go signals are four 1.5 cm letters (A, B, C, D) presented one at a time 
in the center of a computer screen. 
A single test consists of 176 trials in which each of the four-letter stimuli will be presented 
equally. A stop signal occurs in 48 trials during a test. The stop signal consists of a visual cue, 
i.e., “*”, that appears in one of the four corners of the screen. The subjects are required to
withhold any response in case a stop signal is presented. The task has a duration of 10 minutes.
The dependent variables are the proportion of correct Go and Stop responses, and the stop
reaction time. The stop reaction time (SSRT) to stop signal trials represent the estimated mean
time required to inhibit a response. The SSRT is used as a clinical index of inhibitory control,
primarily in the study of ADHD, where impulsive subjects have slower SSRTs (Logan et al.,
1997; Oosterlaan et al., 1998; Rubia et al., 1998). Higher numbers indicate more difficulty
inhibiting responses. Task duration is 10 minutes.
6.2.8.2 Discounting task 
In the delay discounting task subjects are presented 114 questions. For each question, subjects 
have to indicate which of two hypothetical rewards they prefer, the ‘standard’ or the 
‘alternative’ item. The standard item, 100 Swiss francs, is available after one of five delays (0, 
7, 30, 180, or 365 days). The alternative item is an amount of money (1, 25, 50, 100, 150, 200, 
250, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 850, 900, 950, 1000, or 1050 Euros 
(Maastricht site)/Swiss francs (Basel site) available after 0 days). Each combination of standard 
and alternative item is only used once and presented in random order. Subjects are asked to 


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express their preference for an item by pressing one of two buttons. Recorded response choices 
are used afterwards to calculate the switch points per delay at which the subject preferred the 
alternative item over the standard item. Task duration is 10 minutes. Previous research 
demonstrates excessive delays discounting among individuals with ADHD (Kuypers et al., 
2007; Mitchell, 1999). 
6.2.8.3 Psychomotor vigilance task 
The psychomotor vigilance task (PVT) is a sustained attention task, measuring reaction time in 
response to a visual stimulus over a period of 10 minutes. Subjects have to react to the onset of 
a counter as quickly as possible by pressing a response button. Outcome measures are mean 
reaction time (milliseconds) and number of attention lapses, defined as a failure to react, or any 
reaction exceeding 500 msec (Dinges et al., 1985).  
6.2.8.4 Time Production task 
During the time production (TP) task (Hurks et al., 2014), an aspect of time perception is 
measured, namely the ability to estimate and produce the duration of a time interval that is 
presented in numbers. Subjects are presented with a stimulus depicting a candle and a number 
indicative of a time interval (3, 6, 12, 15, 30, or 45 seconds). When this stimulus appears, 
subjects have to press the space bar and are asked to hold the button as long as the number next 
to the candle indicates (e.g., 12 s). As soon as the space bar is released, the stimulus disappears 
from the screen and the procedure repeats itself. The six-time intervals (3, 6, 12, 15, 30, or 45 
seconds) will be presented twice in random order, summing up to 12 trials in total. It will take 
about 5 minutes to complete the task. Dependent variables include the mean duration judgement 
ratio score; first the duration judgement ratio is calculated by taking the ratio of subjective and 
objective duration in milliseconds (i.e., the duration judgment ratio) for each trial; these are 
averaged for each stimulus duration (i.e., 3, 6, 12, 15, 30, or 45 seconds). A score smaller than 
1 represents an underestimation of the stimulus duration, whereas a score larger than 1 
represents an overestimation of the stimulus duration. A mean score will be calculated by 
averaging all six duration judgment scores. 
6.2.8.5 Time Reproduction task 
During the time reproduction (TR) task (Hurks et al., 2011), the ability to reproduce a time 
interval is measured. During this task, subjects will be shown a stimulus (i.e., a row of light 
bulbs, of which only one is turned on) that is presented for a certain time interval (3, 6, 12, 15, 
30, or 45 seconds). This stimulus is followed by a fixation point for 1000 milliseconds. After 
this, the same stimulus (i.e., a row of light bulbs, of which only one is turned on) is shown 
again. Once the row of light bulbs appears, subjects have to press the space bar and hold this 
for as long as the row of light bulbs appeared to them before, thereby reproducing the time 
interval. As soon as the space bar is released, the light bulb switches off and the procedure 
repeats itself. The Good Distribution Practice six-time intervals (3, 6, 12, 15, 30, or 45 seconds) 
will be presented twice in random order, summing up to 12 trials in total. It will take 10 minutes 
to complete the task. Dependent variables include the mean duration judgement ratio score; first 
the duration judgement ratio is calculated by taking the ratio of subjective and objective 
duration in milliseconds (i.e., the duration judgment ratio) for each trial; these are averaged for 
each stimulus duration (i.e., 3, 6, 12, 15, 30, or 45 seconds). A score smaller than 1 represents 


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an underestimation of the stimulus duration, whereas a score larger than 1 represents an 
overestimation of the stimulus duration. A mean score will be calculated by averaging all six 
duration judgment scores. 
7. SAFETY
7.1 Physical Risks to the Subjects 
MM-120 use is not associated with any known physical risks, but it may produce psychiatric
complications as described above and below.
7.1.1. Expected acute adverse effects 
The low dose (20 μg) of MM-120 used in the present study is expected to produce minimal 
subjective and physiological acute adverse effects, including subtle acute feelings of drug 
effect, and slight impairment of cognition (Bershad et al., 2019; Yanakieva et al., 2019). Very 
susceptible persons could potentially experience effects more typically experienced with high 
doses of LSD, including dysphoria, anxiety, mood swings, dream-like state, transient 
depersonalization and derealization phenomena, mild and transient paranoid thinking, negative 
experiences (anxiety, dysphoria, bad trips), tremor, restlessness, acute perceptual changes, 
acutely  impaired psychomotor function, mild tachycardia, mild hypertension, nausea, 
headache, dizziness, trembling, lack of appetite (Dolder et al., 2016; Gasser, 2012b; Johnson et 
al., 2012; Passie et al., 2008; Schmid et al., 2015; Studerus et al., 2011). Adverse effects at a 
dose of 100 μg are expected to completely subside within 24 h at most (Dolder et al., 2016). No 
severe or serious adverse effects are expected based on previous studies using a 20 μg dose of 
MM-120.
7.1.2. Possible lasting adverse effects 
At high doses of LSD, and in rare cases, flashback phenomena psychotic reactions have been 
reported. Negative experiences (bad trips) and flashback phenomena may occur, generally in 
uncontrolled conditions and when high doses of LSD are used (Strassman, 1984). 
7.1.3. Venipuncture  
There is a risk for pain, bruising and thrombophlebitis due to venipuncture. 
7.2 LSD-Specific Toxicity Considerations 
The primary safety concerns with hallucinogen research are psychological rather than 
physiological in nature (Johnson et al., 2008). Even under unsupervised and unprepared 
conditions, reactions to hallucinogens involving violence or self-destructive behavior are rare, 
and it is important not to create an unrealistic account of the dangers of hallucinogens (Johnson 
et al., 2008). Nonetheless, even infrequent reports of such dangers require that we take seriously 
such risks and take steps to avoid their occurrence. Subjects must receive the first dose of MM-
120 in the clinic under supervision to assess for unusual or exaggerated responses and should 
be taken under direct supervision of study personnel to avoid substance deviation. For home 
medication, study medication under the Investigator’s supervision may be administered at home 
to the subject to assure study medication compliance and safety and perform all protocol 


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procedures including AE/SAE, concomitant medication, and C-SSRS assessment. Subject 
cannot drive or operate heavy machinery or do anything else that would be dangerous in an 
impaired state for the remainder of the day after receiving IMP. 
7.2.1. Psychological effects 
There is currently no evidence for positive or adverse psychological effects from controlled 
studies on repeated low dosing LSD. Survey studies among persons performing repeated low 
dosing explored concerns relating to adverse effects. Reported concerns were stronger-than-
expected psychedelic effects, anxiety, and physical adverse side effects (Lea et al., 2020). Other 
perceived limitations include issues related to dosing, taking illegal substances, limited or no 
mental health or cognitive improvement, unpleasant “off” days, only short-term benefits, and 
concerns about dependence and drug-related risks (Lea et al., 2019). In the present study, the 
first dosing will be under full supervision at the research sites. The use of MM-120 as study 
medication will be legal, and the administration of the substance will always be by the study 
personnel or observed by study personnel through a video conference, and as pure substance in 
a precisely known dose. At the dose used, MM-120 should not produce relevant autonomic 
system stimulation based on previous studies. However, it is possible that MM-120 will not 
produce an improvement of ADHD symptomatology, and may not be effective overall, and 
may even worsen symptoms in some subjects. This will be tested in the present study. 
When used at high doses, LSD and other psychoactive substances induce mild or moderate 
anticipatory anxiety at the beginning of the onset of the drug effect (Griffiths et al., 2006; 
Liechti et al., 2001; Schmid et al., 2015). Any such reactions are expected to resolve 
spontaneously with supportive care by the investigators (Griffiths et al., 2011; Griffiths et al., 
2006; Schmid et al., 2015). At the dose of MM-120 to be used in the present study, subjects are 
expected to retain their thought control, and in contrast to psychotic subjects, subjects will 
remain aware of the transient state of the drug-induced experience if they should at all realize 
any change. Events of more pronounced anxiety, panic attacks or agitation are highly unlikely 
to occur. In the case of any psychiatric complications after the study session, and also if the 
subjects would like to discuss negative experiences in association with the study, they can 
contact the study physician, who will offer further assistance beyond the testing days. 
7.2.2. Self-injurious behavior 
People who have taken LSD in uncontrolled settings may engage in reckless behavior, such as 
driving while intoxicated. This risk is greatly reduced by the use of very low doses of LSD. In 
the current study, subjects will take MM-120 under supervision, and remain at the study site for 
the first dosing to assess for any unusual or exaggerated effects, and when the dose is given at 
home it will be under the supervision of the investigator to assure compliance and safety. 
Prolonged psychiatric symptoms and/or psychosis after low dose LSD are rare reactions that 
are unlikely to occur at the dose used in this study, and particularly in the cohort of non-
psychotic subjects to be included in this study. LSD may trigger psychotic episodes in people 
already vulnerable to psychosis rather than directly causing it. 
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The Columbia-Suicide Severity Rating Scale (C-SSRS) is a validated outcome assessment that 
assesses a subject’s suicidal ideation or behavior over a specified time interval (Posner et al., 
2011). Suicidal ideation is assessed on a scale from 1 (wish to be dead) to 5 (active suicidal 
ideation with specific plan and intent). Suicidal behavior is assessed based on responses to 
individual prompts about prior suicidal actions. The C-SSRS will be assessed at all study visits. 
7.2.4. Reproductive and developmental risks 
There are mixed results from preclinical studies evaluating reproductive toxicity, chromosomal 
aberration, and mutagenic studies (refer to the MM-120 Investigator’s Brochure for details). 
Thus, to participate in this study, women of childbearing potential (WOCBP) (i.e., 
physiologically capable of becoming pregnant) must agree to use a highly effective method of 
contraception for the duration of the study, and non-sterilized men who are sexually active with 
a WOCBP must agree to use barrier contraception (e.g., condom with or without spermicidal 
cream or jelly). Subjects who do not agree to these conditions are not eligible to participate in 
the study.   
Appendix 2 provides definitions of WOCBP and highly effective methods of contraception as 
well as information about unacceptable methods of contraception.  Subjects will be provided 
with information on acceptable methods of contraception as part of the informed consent 
process and will confirm when they sign a consent form that they understand the requirements 
for avoidance of pregnancy in the subject or the subject’s sexual partner during the course of 
the study. 
Additional Information for Female Subjects 
WOCBP may participate in the study only if they have a negative urinary pregnancy test (beta 
human chorionic gonadotropin [β-HCG]) result at specified visits prior to dosing (i.e., 
Screening [Visit 1] and Day 1) and every 2 weeks during the dosing phase of the study (through 
Week 6). 
Female subjects who are currently or planning to become pregnant or breastfeed during the 
study period are excluded. If a female subject withdraws early from the study, she should be 
advised not to become pregnant or breastfeed for 3 months after last dose of study drug. Any 
subject that becomes pregnant after Day 1/Dose through Week 6 is required to withdraw from 
the study. The subject will be monitored for the outcome of the pregnancy, and reporting will 
occur as described in Section 7.8. 
Additional Information for Male Subjects 
Male subjects should be encouraged to advise any WOCBP who are their sexual partners to use 
a highly effective method of contraception in addition to the male subject’s use of barrier 
contraception.  A female condom and male condom should not be used together. 
Male subjects who are planning to donate sperm during the study period are excluded. If a male 
subject withdraws early from the study, he should be advised not to donate sperm for at least 
28 days after he received the study drug. 
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MM-120 is not associated with dependence. Hallucinogens are not self-administered by
animals, and there is no human LSD dependence syndrome (Passie et al., 2008). Subjects with
current substance use are not included in the study, but substance use disorder in the past is not
an exclusion criterion. Hallucinogens have been used and are being investigated in several
substance use disorders, including opioid (Belleville et al., 1956; Ross, 2012; Savage et al.,
1973), alcohol (Bogenschutz et al., 2015; Krebs et al., 2012; Kurland et al., 1967; Liester, 2014;
Ludwig et al., 1969; Mangini, 1998; Pahnke et al., 1970), and nicotine dependence (Johnson et
al., 2014). 
7.2.6. Neurotoxicity 
There is no evidence that the active drug substance of MM-120 (LSD) is neurotoxic (Nichols, 
2016; Passie et al., 2014; Passie et al., 2008). 
7.2.7. Flashbacks 
Flashbacks can be defined as episodic and short (seconds or minutes) replications of elements 
of previous substance-related experiences (Holland et al., 2011; Passie et al., 2014). These 
experiences can be positive or negative. Such phenomena have been reported after the use of 
many substances and are also prevalent in non-substance using persons (Holland et al., 2011). 
Clinically significant flashbacks are also defined as hallucinogen persisting perception disorder. 
This disorder is considered rare, but may occur in subjects with anxiety disorders, and it 
typically will have a limited course of months to a year (Halpern et al., 1999; Holland et al., 
2011; Passie et al., 2014). At a follow-up one month after LSD (200 μg) administration, none 
of 16 healthy subjects reported any perceptual changes (e.g., flashbacks) (Schmid et al., 2018). 
With regards to the present study, no visual alterations are expected at the doses used, and 
therefore flashbacks are very unlikely to occur. 
7.3 Safety Monitoring 
Guidelines for hallucinogen research have been published that relate to high dose 
(approximately 100 μg and above) use of psychedelics, and not to the low dose (20 μg) used in 
the present study (Fischman et al., 1998; Gouzoulis-Mayfrank et al., 1998; Johnson et al., 2008). 
The procedures are intended to support the safe administration of psychoactive substances while 
minimizing potential adverse reactions. The dose of MM-120 used in the present study is much 
lower at 20 μg, and safety data is based on previous clinical studies in healthy volunteers. 
7.3.1. Other psychiatric disorders 
The psychiatric screening criteria are important for minimizing the already low chances of 
precipitating a longer-term psychotic reaction to MM-120. Subjects who have a present or past 
history of meeting DSM-5 criteria for schizophrenia, or other psychotic disorders (or due to a 
medical condition), or bipolar disorder are excluded. The above are the most important 
conditions to exclude for ensuring safety. Subjects with a first-degree relative with these 
disorders are also excluded. Other psychiatric disorders such as co-morbid depression, 
obsessive-compulsive disorders, anxiety or previous substance use disorder are not excluded 
because hallucinogens have been used in subjects with these disorders, or specifically to treat 


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these disorders (Gasser, 2012a; Gasser et al., 2015; Grob et al., 2011; Krebs et al., 2012; Moreno 
et al., 2006; Ross, 2012). 
7.3.2. Predictors for response 
Relevant for high-dose psychedelic research, factors that predict more pleasant and mystical-
type experiences following hallucinogen administration include high scores of the personality 
trait of absorption (open to new experiences) and having experienced few psychological 
problems in the past weeks before the test sessions (Studerus et al., 2012). Factors associated 
with an unpleasant and/or anxious reaction to the hallucinogen are low age, emotional lability, 
and a setting involving a brain scan (Johnson et al., 2008; Studerus et al., 2012). With regard to 
personality, subjects who are more open to new experiences, including the use of hallucinogens, 
will more likely be interested in participating in the study, and this self-selection bias enhances 
the safety of such research (Johnson et al., 2008; Studerus et al., 2011). 
7.3.3. Drug experience 
Previous experience with psychoactive drugs may influence the response to psychoactive 
substances. In controlled studies with psilocybin, drug use and pre-experience with 
hallucinogens only moderately affected the psilocybin response (Studerus et al., 2012). 
Hallucinogen-naïve subjects tended to report overall stronger psilocybin effects (Studerus et 
al., 2012). Subjects who sometimes smoked cannabis (more than once per month) experienced 
more pleasurable effects and a trend towards less anxiety compared to subjects who rarely used 
THC (Studerus et al., 2012). No difference was found in the response to LSD between healthy 
subjects with previous experience with hallucinogen use and hallucinogen-naïve subjects 
(Schmid et al., 2015). Of note, subjects with regular drug use were not included in the above 
study (Studerus et al., 2012). The present study will also include mostly subjects with no or 
only limited previous drug exposures, similar to previous studies using LSD (Dolder et al., 
2017b; Gasser et al., 2014; Gasser et al., 2015; Schmid et al., 2015), and similar to studies 
conducted by others using psilocybin (Griffiths et al., 2011; Griffiths et al., 2006; Studerus et 
al., 2011). 
7.4 Safety Procedures During the Session 
7.4.1. Adverse cardiovascular effects 
No clinically relevant cardio-stimulant effects are expected at the dose of MM-120 to be used 
in the present study. Only mild cardio-stimulant effects are expected at high doses of LSD 
(Dolder et al., 2016). Cardiovascular effects (blood pressure and heart rate) will be repeatedly 
measured during the first dosing to document the absence of relevant effects. Closer monitoring 
would be implemented in the unexpected case of blood pressure values exceeding 180/120 mm 
Hg or decrease below 90 mm Hg for systolic blood pressure. Treatment of a hypertensive 
reaction (Psys > 220 mmHg) may include lorazepam and nitroglycerine, per Investigator 
decision and Sponsor medical monitor notified. Treatment of hypotension would include 
Trendelenburg position. Cardiac arrest would trigger immediate cardiopulmonary reanimation 
and a call to the ambulance. 
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MM-120 may produce transient headaches (Schmid et al., 2015). One participant (out of 16)
required acetaminophen for a moderate headache the day after a LSD session. Conversely, the
active drug substance LSD reportedly reduces episodes of cluster headache and migraine
(Davenport, 2016; Karst et al., 2010; Sewell et al., 2006), and is currently being tested for these
indications in the context of compassionate use, and with authorization of the Swiss Federal
Office of Public Health (BAG) in selected cases. In the pilot study with subjects suffering from
anxiety associated with life-threatening diseases, LSD markedly reduced the number of
migraine attacks in two migraine subjects (Gasser et al., 2014).
7.4.3. AEs between sessions 
AE and SAE will be assessed at each study visit and at the follow-up visit at the end of the 
study. 
7.5 Risk Benefit Assessment 
7.5.1. Potential benefits 
Based on previous anecdotal reports from LSD users practicing repeated low dosing, MM-120 
may provide a benefit to ADHD subjects. There is no preliminary data from controlled studies 
to support a benefit. Therefore, this investigation is the first to explore potential beneficial 
effects of low doses of LSD in a proof-of-concept study. The study will provide information on 
the efficacy of MM-120 in the treatment of ADHD, and therefore potentially provide benefit to 
future subjects, or if efficacy is not supported, help to avoid unnecessary treatment. 
7.5.2. Potential harms to subjects 
The risk of lasting psychological harm is considered low, and the risks of physical harm very 
low (see above). The risk of not being provided alternative treatment is minimal and temporary 
because only subjects who have stopped other treatment options are included or subjects who 
do not mandatorily need other ADHD medication. The subjects might experience some 
disadvantage when they stop their medication, which is evaluated as low risk and not life 
threatening. Subjects are free to stop their study participation at any time without any 
justification. There are no financial risks. Travel expenses are reimbursed to the subjects.  
7.6 Safety Definitions 
7.6.1. Adverse Event 
An Adverse Event (AE) is any untoward medical occurrence in a clinical trial subject 
administered an IMP and which does not necessarily have a causal relationship with this 
treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal 
laboratory finding), or any clinically significant change from baseline, whether considered 
positive (e.g., marked feelings of a drug high, feeling happy) or negative symptom (e.g., feeling 
panicked, fearful, or sad), change in sleep, quality or duration, or disease temporally associated 
with the use of an IMP, whether or not considered related to the IMP. 
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An Adverse Reaction (AR) is any untoward and unintended responses to an IMP judged by 
Investigator/Sponsor as having a reasonable causal relationship to the IMP. The expression 
reasonable causal relationship means to convey in general that there is evidence or argument to 
suggest a causal relationship. 
7.6.3. Unexpected Adverse Reaction 
An Unexpected Adverse Reaction (UAR) is an adverse reaction (AR), the nature or severity of 
which is not consistent with the applicable product information (e.g., Investigator’s brochure 
[IB] for an unapproved investigational product or summary of product characteristics [SmPC] 
for an authorized product). When the outcome of the adverse reaction is not consistent with the 
applicable product information, this adverse reaction should be considered as unexpected. Side 
effects documented in the IB, or SmPC which occur in a more severe form than anticipated, are 
also considered as being unexpected. 
7.6.4. Serious Adverse Event or Serious Adverse Reaction 
A Serious Adverse Event (SAE) is any untoward medical occurrence or effect that at any dose 
results in death, is life-threatening, requires hospitalization, or prolongation of existing 
hospitalization, results in persistent or significant disability, or incapacity, or is a congenital 
anomaly or birth defect. In this context, the term life-threatening refers to an event in which the 
trial participant was at immediate risk of death at the time of the event; it does not refer to an 
event which might have caused death if it were more severe. 
A Serious Adverse Reaction (SAR) is an SAE that is determined to be related to the 
intervention. Based on the causality definitions in Section 10.7, SAEs that are determined to 
have a causal relationship of “possible”, “probable” or “definitely” will be considered SARs. 
7.6.5. Suspected Unexpected Serious Adverse Reaction 
A Suspected Unexpected Serious Adverse Reaction (SUSAR) is any suspected adverse reaction 
related to an IMP that is both unexpected and serious. 
The Investigator evaluates SAEs for seriousness and causality in consultation with the Sponsor 
Medical Monitor, as necessary. Expectedness is also determined by the Sponsor’s Medical 
Monitor based on an assessment of the adverse event in the context of previously reported 
adverse events, as outlined in the Investigators’ Brochure and/or study protocol. If the event is 
related to the IMP and is both serious and unexpected, it is classified as a SUSAR.  
For purposes of defining a SUSAR, any SAE that has a causality of “possibly”, “probably” or 
“definitely” will be considered to be related to the IMP.  
7.7 Causality 
Most adverse events and adverse reactions that occur in this study, whether they are serious or 
not, will be expected treatment-related toxicities due to the medication used in this study. The 
assignment of the causality will be made by the Investigator using the definitions in the table 
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Relationship 
Description 
Unrelated 
There is no evidence of any causal relationship. 
Unlikely 
There is little evidence to suggest there is a causal relationship (e.g., the event did not 
occur within a reasonable time after administration of the IMP). There is another 
reasonable explanation for the event (e.g., the participant’s clinical condition, other 
concomitant treatment). 
Possible 
There is some evidence to suggest a causal relationship (e.g., because the event occurs 
within a reasonable time after administration of the IMP). However, the influence of 
other factors may have contributed to the event (e.g. the participant’s clinical 
condition, other concomitant treatments). 
Probable 
There is evidence to suggest a causal relationship and the influence of other factors is 
unlikely. 
Definitely 
There is clear evidence to suggest a causal relationship and other possible contributing 
factors can be ruled out. 
7.8 Documentation 
All adverse events occurring after the subject has signed the informed consent will be fully 
recorded in the subject’s eCRF. Each event will be described in detail, along with start and stop 
dates, severity, relationship to IMP, action taken and outcome. 
7.8.1. Adverse events documentation 
AEs will be described and recorded on the subject’s eCRF, regardless of the severity or 
relationship to the IMP. AEs are rated for severity, and the potential relationship regarding the 
study interventions will be evaluated by the Investigator according to standard criteria. Subjects 
with AEs will be treated appropriately. Abnormal laboratory values not explained by the 
subjects’ disease will be repeated until normal, or until the abnormality can be explained, and 
the subject’s safety is not at risk. 
7.8.2. SAE and SUSAR reporting 
Should a SAE occur, the Principal Investigator (PI) will be informed and relationship to the 
study drug will be assessed by the PI using the definitions shown above. Complete information 
concerning the SAE will be collected by the PI and documented on a standard SAE form. SAE 
leading to death will be reported to the EC by the PI within 7 days. SUSARs leading to death 
or any other SUSARs will be reported to the EC within 7 and 15 days respectively. 
7.9 Medical Follow-Up of Adverse Events 
The Investigator will ensure the subject receives medical follow-up as necessary until the 
condition has stabilized or returned to normal state, even if the period of the trial is over. 
7.10 Screening Procedures 
7.10.1. 
Informed consent 


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For this study, the subject must be cognitively able to understand the requirements of the study 
and provide the informed consent to participate in the study; use of a legally authorized 
representative to provide consent to participate is not allowed. Informed consent forms (ICFs), 
any subsequently revised written ICFs, and any written information provided to the subject 
must receive Institutional Ethics Committee (IEC) approval in advance of use. The subject 
should be informed in a timely manner if new information becomes available that may be 
relevant to the subject’s willingness to continue participation in the study. The communication 
of this information will be provided and documented via a revised main ICF or addendum to 
the original ICF that captures the subject’s dated signature. 
●
The ICFs will adhere to IEC requirements, applicable laws and regulations and Sponsor
requirements.
7.10.2. 
Changes to protocol and informed consent forms 
Study procedures will not be changed without the mutual agreement of the Investigator and 
Sponsor. If there are any substantial changes to the study protocol, these changes will be 
documented in a study protocol amendment and, where required, in a new version of the study 
protocol (Revised Protocol). The Sponsor will distribute any subsequent amendments and new 
versions of the protocol to the Investigator. If a protocol amendment requires a change to the 
ICF, the Sponsor and the EC should approve the revised ICF before the revised form is used. If 
local regulations require, any administrative change will be communicated to or approved by 
the EC. 
7.10.3. 
Physical health 
Subjects will be examined by a study physician, including medical history, physical 
examination, ECG, vital signs, and laboratory blood tests at screening and at the end of study 
visit. Body weight and height will also be measured. Additionally, a psychiatric interview will 
be performed at the screening. 
7.10.4. 
Mental health 
Subjects will be screened using the MINI. The psychiatric interview is conducted by a trained 
site study staff who also decides whether subjects meet the psychiatric inclusion criteria. The 
C-SSRS will be conducted to screen for suicidality.
 
 
 
 
 
 
 
 
 


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7.10.6. 
Laboratory tests 
A routine laboratory blood test will be performed at the screening examination, and similarly 
during the treatment period and at the follow-up visit (see Schedule of Events); see Section 8.2. 
In addition, 
 a urine pregnancy test (only in women) are performed at 
select time points before IP dosing throughout the study; see Section 8.2. 
7.10.7. 
Re-Screening 
Screen failures are subjects who consent to participate in the clinical study but are never 
randomized. 
Subjects excluded during screening should promptly be reported as a screen failure in the 
electronic data capture (EDC) system. 
7.11 Urgent Safety Measures 
All arrangements described in this section apply only to the extent that protocol requirements 
cannot be met because of restrictions due to a crisis, such as the COVID-19 pandemic. Study 
center visits should take place to the extent possible and usual protocol requirements adopted 
for all subjects as soon as the crisis-related limitations permit. Exceptional measures taken in 
response to a crisis (e.g., COVID-19) and their impact on study results, such as tests done in a 
different local laboratory, will be explained, assessed, and reported in the clinical study report 
following ICH E3 guidance. 
In case any visit described in the Schedule of Events (Section 6.1) that is required to be 
conducted in-clinic and cannot be conducted at the study center within the visit window due to 
restrictions related to COVID-19 or another such crisis, a telephone visit, home visit and/or 
video call should be arranged. The telephone visit should include all protocol assessments that 
can be performed remotely and should take place within the original visit window. A home visit 
requires the PI or delegate to conduct all safety assessments and record AEs. A supportive 
person of the subject’s choosing may be present with the subject in the home. The decision to 
replace the study center visit with an alternate contact method will be made by the Investigator 
on a case-by-case basis, and the Sponsor’s Medical Monitor and clinical operations project 
manager should be informed of each case as early as possible. In addition to the remote visit, 
the Investigator should complete the following assessments/procedures: 
●
Outcome clinical assessments e.g., AISRS, CGI
●
Concomitant medication review/collection
●
Check daily diary
●
Adverse event collection
●
Safety laboratory assessment (if required at that visit)
●
Urine pregnancy test (if required at that visit)


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●
C-SSRS – SLV Version
For scheduled visits that require additional assessments such as clinical laboratory 
measurements, the use of local practitioners and resources may be employed. In case these 
assessments cannot be obtained within a reasonable time after the remote visit contact, the 
benefit-risk ratio for the subject to continue in the study should be reassessed. 
All safety data that are possible to obtain locally should be collected at the remote visit. 
7.12 Special Situations 
Special situations with study drug are defined as the following: 
●
Medication error or incorrect drug administration
●
Overdose (exceeds the protocol-specified maximum; see Section 9.4 for the definition of
overdose)
●
Deliberate abuse
●
Deliberate misuse
●
Drug interaction
●
Occupational exposure
If any of these special situations with study drug occur, they will be reported on the special 
situations with study drug eCRF page, even if there is no accompanying AE. All clinical 
manifestations in relation to these special situations will be reported as AEs or SAEs at the same 
time using the corresponding section of the eCRF. 
For example, if a medication error or interaction occurred, the Investigator will assess whether 
to consider an AE to have occurred, and if so, will assign the possible relationship to the study 
drug.   
Additional information may be requested by the site including all AE information and all 
triggering drug accountability discrepancies. 
8. COLLECTION OF STUDY VARIABLES
The study assessments are described in the sections below and the timing of these assessments 
are detailed in the Schedule of Events (Section 6.1). 
8.1 Recording of Data 
For this study, subject data will be collected on electronic Case Report Forms (eCRFs). The 
Investigator will ensure the accuracy, completeness, and timeliness of the data recorded, data 
queries, and all required reports according to any instructions provided in the eCRF completion 
guidelines. 


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8.2 Clinical Laboratory Assessment 
8.2.1. Clinical chemistry 
The laboratory parameters listed below will be measured: 
Standard Chemistry 
●
Albumin
●
Total protein
●
Alkaline phosphatase
●
ALT
●
AST
●
Bilirubin, total (reflex direct bilirubin of
total bilirubin is >ULN)
●
Blood urea nitrogen or urea
●
Calcium
●
Chloride
●
Creatinine
●
Creatinine clearance (CKD-EPI)
●
FSHa (to confirm postmenopausal
status)
●
GGT
●
Glucose
●
Lactate dehydrogenase
●
Phosphate
●
Potassium
●
Sodium
Hematology complete blood count, including: 
●
Hemoglobin
●
Hematocrit
●
Reflex RBC indices if hematocrit/ hemoglobin are abnormal:
o
MCV
o
MCH
●
Platelet count
●
Red blood cell count
●
White blood cell count
●
Reflex differential count if WBC is elevated, including:
o
Basophils
o
Eosinophils
o
Lymphocytes
o
Monocytes
o
Neutrophils
Urine pregnancy test 
 


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8.2.2. Physical examination 
A physical examination will be performed at screening, Week 6, and at Week 10 visits and 
include an assessment of the following: general appearance, skin, head and neck, lymph nodes, 
thyroid, abdomen, musculoskeletal, cardiovascular, respiratory, and neurological systems. An 
assessment for any signs or symptoms of skin irritation will be noted in source and eCRF. 
Height will be measured in centimeters and weight in kilograms. Measurements should be taken 
without shoes for all measurements. Body mass index (BMI) will be calculated from the height 
and weight measurements at screening. 
8.2.3. Resting 12-Lead ECG 
A 12-lead ECG will be obtained after the subject has been resting in the supine position for at 
least 5 minutes, at time points outlined in the Schedule of Events. All ECGs will be documented 
by recording date, time of collection, all abnormal waveform noted, heart rate, all intervals 
including PR, RR, QRS, QT, and QTcF/QTcB intervals from the 12-lead ECG. The Investigator 
will judge the overall interpretation as normal or abnormal. If abnormal, it will be decided 
whether or not the abnormality is clinically significant or not clinically significant, and the 
reason for the abnormality will be recorded. The date/time and the physician interpretation 
(normal, abnormal clinically significant, abnormal not clinically significant) for the paper ECGs 
will be stored as source documents as a paper printout. Skin preparation must be thorough and 
electrode positions must be according to standard 12-lead ECG placement. 
8.2.4. Vital signs 


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Vital signs will be measured according to the Schedule of Events. Vital signs should be obtained 
after the subject has been resting in a supine position for at least 5 minutes. 
8.2.5. Supine pulse and blood pressure 
Blood pressure will be measured using a semiautomatic blood pressure recording device with 
an appropriate cuff size. Subjects will be required to rest in a supine position for at least 5 
minutes prior to taking blood pressure, and pulse rate measurements. 
8.2.6. Body temperature 
Body temperature (tympanic) will be measured in degrees of Celsius using an automated 
thermometer. No hot/cold beverage/food is allowed for 15 minutes before the temperature is 
measured. 
8.2.7. Emergency treatment 
During and following a subject’s participation in the trial, the Investigator/institution should 
ensure that adequate medical care is provided to a subject for any AEs, including clinically 
significant laboratory values, related to the trial. 
8.3 Pharmacokinetics 
8.3.1. Collection of pharmacokinetic samples 
The timing and number of PK samples will be at 0, 0.5, 1, 2, 3, 4 and 6 hours. The actual date 
and time of collection of each sample will be recorded on the eCRF. Samples will be collected 
(aliquot and back-up) to be stored at -20°C (for the back-up) and -80°C (for the aliquot). Blood 
samples will be collected in heparinized/EDTA tubes, centrifuged at 4°C at 3000 rpm for 10 
min, and the plasma is then stored at -20°C until shipping/analysis.  
8.4 Pharmacodynamics 
The acute subjective effects of MM-120 and placebo will be assessed for 6 hours after 
administration on Day 1 and after the last dose, using the 5 Dimensions of Altered States of 
Consciousness Questionnaire (5D-ASC), and the Mystical Experience Questionnaire 30 item 
(MEQ30). The 5D-ASC and MEQ30 will also be self-administered at home on 6 hours after 
dosing on the first and last dosing days. Additionally, a series of single item Visual Analog 
Scales (VAS) will be used to self-rate acute drug effects repeatedly 0-6 hours after drug 
administration of the first dose of IMP. 
8.4.1. 5D-ASC 
The 5D-ASC scale is a visual analog scale consisting of 94 items (Dittrich, 1998; Studerus et 
al., 2010). The instrument is constructed of five scales, and allows assessing mood, anxiety, 
derealization, depersonalization, changes in perception, auditory alterations, and reduced 
vigilance. The scale is well-validated and has been used to characterize the acute subjective 
effects of LSD in experimental studies. The 5D-ASC scale will be administered 6 h after dosing 
of the first and last dose of MM-120, and subjects are instructed to retrospectively rate peak 


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alterations. Each item of the scale is scored on a 0-100 mm VAS. Subjects will complete this 
assessment at home. 
8.4.2. MEQ30 
This 30-item questionnaire is rated on a six-point scale. The scale has been used to assess 
mystical experiences in studies using psilocybin and LSD. The MEQ30 will be administered 6 
hours after drug administration of the first and last dose of MM-120, and subjects are instructed 
to retrospectively rate peak alterations. Data on each domain scale will be expressed as a 
percentage of the maximum possible score. Subjects will complete this assessment at home. 
8.4.3. VAS 
A series of single item VAS will be used repeatedly 0-6 hours after the first drug administration. 
The following VAS items will be used: “any drug effect”, “good drug effect”, bad drug effect”, 
“drug liking”, “fear”, nausea”, “alteration of vision”, “alteration of sense of time”, and “the 
boundaries between myself and my surroundings seem to blur”. 
9. BIOLOGICAL SAMPLING PROCEDURES
9.1 Volume of Blood 
Blood samples for determination of plasma concentration of MM-120 will be collected pre- and 
post-dose on Day 1. The sampling scheme and sampling duration, without exceeding the 
maximal sample number, duration, or maximal blood volume in this protocol, will be 
maintained. 
The number of samples to be obtained, as well as the volume required for each analysis, may 
be changed during the study as new data become available. However, the maximum volume to 
be drawn from each subject will be approximately 120 mL. 
9.2 Handling, Storage and Destruction of Biological Samples 
The samples will be used or disposed of after analyses. 
9.2.1. Quality control of PK samples 
Additional analyses will be conducted on the biological samples to investigate the 
reproducibility of the analytical results in incurred samples. Any results from such analyses will 
only be used to confirm the reproducibility of the method and will be reported in a separate 
table in the bioanalytical study contribution report. 
10.
ETHICAL AND REGULATORY REQUIREMENTS
10.1 Ethical Conduct of Study 
The study will be performed in accordance with ethical principles that have their origin in the 
Declaration of Helsinki and are consistent with International Conference on Harmonization 
(ICH) Good Clinical Practice (GCP). 


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10.2 Subject Data Protection 
The informed consent form (ICF) will incorporate (or, in some cases, be accompanied by a 
separate document incorporating) wording that complies with relevant data protection and 
privacy legislation. 
10.3 Ethics and Regulatory Review 
This study will be conducted in compliance with the protocol, the current version of the 
Declaration of Helsinki (9th July 2018), the ICH-GCP as well as all national legal and 
regulatory requirements. The Ethics Committees (ECs) should approve the final study protocol, 
including the final version of the ICF and any other written information and/or materials to be 
provided to the subjects. The Investigators will ensure the distribution of these documents to 
the applicable EC, and to the study site staff. The opinion of the EC should be given in writing. 
The Investigator should submit the written approval to the Sponsor before enrolment of any 
subject into the study. 
The EC should approve all advertising used to recruit subjects for the study. 
The Sponsor will approve any modifications to the ICF that are needed to meet local 
requirements. The IB will be updated and reviewed annually by the Sponsor. 
10.4 Informed Consent 
Any provisions for subjects harmed as a consequence of study participation should be described 
in the ICF that is approved by an EC. 
The Investigator will: 
●
Ensure that each subject is given full and adequate oral and written information about the
nature, purpose, possible risk, and benefit of the study.
●
Ensure that each subject is notified that they are free to withdraw from the study at any time.
●
Ensure that each subject is given the opportunity to ask questions and allowed time to
consider the information provided.
●
Ensure each subject provides signed and dated informed consent before conducting any
procedure specifically, for the study.
●
Ensure the original, signed ICF is stored in the Investigator’s Study File (ISF).
●
Ensure copies of the signed ICF are given to the subject.
10.5 Changes to Protocol and Informed Consent Forms 
Study procedures will not be changed without the mutual agreement of the Investigator and 
Sponsor. If there are any substantial changes to the study protocol, these changes will be 
documented in a study protocol amendment and, where required, in a new version of the study 
protocol (Revised Protocol). The Sponsor will distribute any subsequent amendments and new 
versions of the protocol to the Investigator. If a protocol amendment requires a change to the 
ICF, the Sponsor and the EC should approve the revised ICF before the revised form is used. If 


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local regulations require, any administrative change will be communicated to or approved by 
the EC. 
10.6 Audits and Inspections 
Authorized representatives of the Sponsor, Health Authority, or an EC may perform audits or 
inspections at the center, including source data verification. The purpose of an audit or 
inspection is to systematically and independently examine all study-related activities and 
documents to determine whether these activities were conducted, and data were recorded, 
analyzed, and accurately reported according to the protocol, GCP, guidelines of the ICH, and 
any applicable regulatory requirements. The Investigator will contact the Sponsor immediately 
if contacted by a regulatory agency about an inspection at the center. 
11.
STUDY MANAGEMENT
11.1 Pre-study Activities 
Before the first subject is entered into the study, it is necessary for a representative of the 
Sponsor, or their delegate, to visit the investigational study site to: 
●
Determine the adequacy of the facilities
●
Determine availability of subjects appropriate for the study
●
Discuss with the Investigator (and other personnel involved with the study) their
responsibilities with regards to protocol adherence, and the responsibilities of the Sponsor
or its representatives. This will be documented in a Clinical Study Agreement between the
Sponsor and the Investigator.
11.1.1. 
Training of Study Site Personnel 
Before the first subject is entered into the study, a Sponsor’s representative will review and 
discuss the requirements of the study protocol and related documents with the investigational 
staff, and train them in any study-specific procedures and system(s) utilized. 
The Investigator will ensure that appropriate training relevant to the study is given to all staff, 
and that any new information relevant to the performance of this study is forwarded to the staff 
involved. 
The Investigator will maintain a record of all individuals involved in the study (medical, 
nursing, and other staff). 
11.1.2. 
Monitoring of Study 
During the study, a representative of the Sponsor will have regular contact with the study site 
for the following reasons: 
●
To conduct visits to provide information and support to the Investigator,
●
To confirm that facilities remain acceptable,
●
To confirm


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that the investigational team is adhering to the protocol,
o
that data are being accurately and timely recorded in the eCRFs,
o
that biological samples are handled correctly, and
o
that IMP accountability checks are being performed,
●
To perform source data verification (a comparison of the data in the electronic data capture
[EDC] system with the subject’s medical records at the hospital or practice, and other
records relevant to the study) including verification of informed consent of participating
subjects.
o
Note that this will require direct access to all original records for each subject
●
To ensure that any subject’s withdrawal of informed consent to use of their biological
samples is correctly reported and that these biological samples are identified and disposed
of/destroyed accordingly, and the action is documented and reported to the subject.
The Sponsor’s representative will be available between visits if the Investigator or other staff 
at the site needs information and advice about the study conduct. 
Each site will comply with applicable laws per each regulatory authority. The Investigator is 
responsible for ensuring compliance at the site with all procedures and details of drug handling, 
storage and accountability for dosing, tracking, control and return via reverse distributor, and 
prevention of unauthorized access. 
11.1.3. 
Study agreements 
The Investigator should comply with all the terms, conditions, and obligations of the Clinical 
Study Agreement for this study. In the event of any inconsistency between this study protocol 
and the Clinical Study Agreement, the study protocol shall prevail with respect to the conduct 
of the study and the treatment of subjects and in all other respects, the terms of the Clinical 
Study Agreement shall prevail. Agreements between the Sponsor and the Investigator should 
be in place before any study-related procedures can take place or subjects are enrolled. 
11.1.4. 
Archiving of study documents 
The Investigator follows the principles outlined in the Clinical Study Agreement. 
11.1.5. 
Study termination 
The study may be terminated if the study procedures are not being performed according to GCP, 
or according to the protocol, or if recruitment is slow. The Sponsor may also terminate the entire 
study prematurely if concerns for safety arise within this study. 
11.2 Data Management by a Delegate 
Data management will be performed by the Sponsor or its delegate. Data queries will be raised 
for inconsistent, impossible, or missing data. All entries to the study database will be available 
in an audit trail. The data will be validated as defined in the Data Management Plan. Quality 
control procedures will be applied to each stage of data handling to ensure that all data are 
reliable and have been processed correctly. When all data have been coded, validated, and 
locked, a clean file will be declared. Any treatment-revealing data may thereafter be added, and 


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the final database will be locked. Data storage will be done in accordance with GCP guidelines. 
The Data Management Plan will describe the methods used to collect, check, and process 
clinical data in detail. It will also clarify the roles and responsibilities for the different functions 
and personnel involved in the data management process. Furthermore, the Data Management 
Plan will describe the data flow and timelines within the study. 
12.
EVALUATION AND CALCULATION OF VARIABLES
12.1 Calculation or Derivation of Safety Variable(s) 
The verbatim terms used in the eCRF by investigators to identify adverse events will be coded 
using the Medical Dictionary for Regulatory Activities (MedDRA). Intervention-emergent 
adverse events are adverse events with onset after the intervention phase or that are a 
consequence of a pre-existing condition that has worsened since treatment start. All reported 
adverse events will be included in the analysis. For each adverse event, the percentage of 
subjects who experience at least one occurrence of the given event will be summarized by 
treatment arm. In addition, comparisons between intervention groups will be provided as 
appropriate. 
Summaries, listings, datasets, or subject narratives may be provided, as appropriate, for those 
subjects who die, or who experience a severe or a serious adverse event. 
Safety outcomes, including vital signs, laboratory parameters' values, ECG parameters and 
abnormalities, will be reported by treatment arm. All safety data (scheduled and unscheduled) 
will be presented in the data listings. Continuous variables will be summarized using descriptive 
statistics (n, mean, SD, minimum, median, and maximum) by treatment/dose group at relevant 
timepoints. Categorical variables will be summarized in frequency tables (frequency and 
proportion) by treatment/dose group at relevant timepoints. Graphical presentations will be used 
as appropriate. 
Where applicable, data will be summarized for the absolute value at each scheduled assessment 
and for the corresponding change from baseline. For clinical laboratory tests, listings of values 
for each participant will be presented with abnormal or out-of-range values flagged. The 
percentage of subjects with values beyond clinically important limits will be summarized by 
frequency tables and shift tables.  
Treatment emergent ECG abnormalities will be summarized similarly to AEs. 
12.2 Other Significant Adverse Events 
During the evaluation of the AE data, the Sponsor’s medically qualified expert will review the 
list of AEs that were not reported as SAEs or AEs leading to discontinuation. Based on the 
expert’s judgment, significant AEs of particular clinical importance may be considered other 
significant adverse events (OAEs) and reported as such in the Clinical Study Report (CSR). A 
similar review of other data from laboratory tests, vital signs, ECGs, and other safety 
assessments will be performed for identification of OAEs. Examples of these are marked 


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hematological and other laboratory abnormalities, certain events that lead to intervention (other 
than those already classified as serious), or significant additional treatment. 
13.
STATISTICAL METHODS AND SAMPLE SIZE
13.1 Data Analysis 
The statistical analysis will be done by the Sponsor or under the authority of the Sponsor. A 
general description of the statistical methods to be used to analyze the efficacy and safety data 
is outlined below. Specific details will be provided in the Statistical Analysis Plan (SAP) that 
will be finalized prior to unblinding.  
13.2 Analysis Sets 
The following analysis sets will be defined for the statistical analysis. Subjects without valid 
written study informed consent will be excluded from all analysis sets.  
●
Randomized set (RAN) – All subjects who received a randomization number, regardless
of receiving trial medication.
●
Safety set (SAF) – All subjects who received the double-blind study drug. Subjects will be
analyzed according to treatment received.
●
Full analysis set (FAS) – All subjects in RAN who were not mis-randomized
†  Following the intent-to-treat (ITT) principle, subjects are analyzed according to the
treatment they have been assigned to at the randomization. 
†  Mis-randomized subjects are those who have not been qualified for randomization and 
who have been inadvertently randomized into the study but have not received double-
blind study drug.  
●
Per protocol set (PPS) – All subjects in FAS who took the study medication and had no
major protocol deviations
●
Pharmacokinetic analysis set (PKAS) –The PK analysis set will include all participants
who receive a dose of MM-120 and have at least 1 postdose PK measurement without
important protocol deviations or violations thought to significantly affect the PK of the drug.
Data from participants with deviations determined to affect PK will be excluded from the
PK analysis set. Participants that receive placebo will not be part of the PK analysis set. A
strategy for dealing with data affected by protocol violations and deviations will be agreed
to by the Sponsor, monitor, and pharmacokineticist, prior to clean file and code break.
Participants will be analyzed according to the treatment they actually received.
‡  Subjects will be analyzed according to the treatment received.
‡  Major protocol deviations are those affecting the primary endpoint analyses and will be
finalized prior to unblinding treatment codes for analyses. A list will be provided in the 
Clinical Study Report Statistical Analysis Plan.  
13.3 Subject demographics and other baseline characteristics 
Summary statistics will be provided by treatment group for demographics and baseline 
characteristics, including sex, age, weight, height, BMI, systolic blood pressure, diastolic blood 


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pressure, geographical region, medical history, baseline values for AISRS, CGI-S, ASRS, and 
CAARS. These summaries will be performed for the FAS.  
Continuous variables will be summarized using n, mean, standard deviation (SD), median, Q1 
(25th percentile), Q3 (75th percentile), minimum, and maximum. Categorical variables will be 
summarized using frequency and incidence. 
13.4 Treatment Exposure 
Exposure to randomized treatment for the SAF set during the double-blind treatment period 
will be summarized in terms of treatment duration, calculated as the number of days from the 
date of first dose of randomized treatment received to the date of the last dose received, 
inclusive. Descriptive statistics (n, mean, SD, minimum, median, and maximum) will be 
presented by treatment group for treatment exposure. The total number of doses received by a 
subject during the double-blind treatment period will be summarized by treatment group for the 
SAF. 
13.5 Prior and Concomitant Medication 
Prior medication is defined as any medication taken before the date of the first dose of 
randomized treatment. Concomitant medication is defined as any medication taken on or after 
the date of the first dose of randomized treatment. 
Both prior and concomitant medication use will be summarized by the number and proportion 
of subjects in each treatment group receiving each medication within each therapeutic class for 
the SAF. 
13.6 Efficacy Analyses 
13.6.1. 
Primary estimand 
The primary estimand quantifies the treatment effect of MM-120 at 6-weeks vs placebo after 
twice weekly administration while accounting for intercurrent events (IEs) with potential 
confounding effects and IEs leading to study discontinuation prior to the 6-week assessment. 
The following attributes describe the primary estimand: 
●
Population: As defined by the Inclusion/Exclusion criteria
●
Endpoint: Change from baseline to Week 6 in the AISRS Score
●
Treatment of interest: the randomized treatment MM-120 or placebo as a twice weekly
treatment.
●
Handling of intercurrent events (IEs) prior to AISRS assessments.
o
Intake or change in concomitant medications/therapies which have potential
confounding effects
o
Intake of prohibited medications/therapies
o
Other IEs leading to treatment/study discontinuation (except those related to COVID-
19 pandemic.


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Policy strategy. Available data recorded after the IE will be set to missing; such missing
data will be imputed/substituted under a MNAR assumption by borrowing information
from the placebo arm subjects (reference-based imputation).
o
IEs related to COVID-19 pandemic and other intercurrent missing data
o
Policy strategy. Available data will be used; missing data will be imputed under a MAR
assumption by borrowing information from subjects in the same treatment arm.
●
Summary measure: Difference between MM-120 and placebo in mean change from
baseline to Week 6 for AISRS Score.
13.6.2. 
Statistical methods and analysis 
The primary analysis will be performed according to the intent-to-treat (ITT) principle on the 
FAS.  
The effect on the primary endpoint, change in AISRS score from baseline to Week 6, will be 
estimated by applying Rubin's rule to a multiple imputations procedure to appropriate contrasts 
based on Mixed Model for Repeated Measures (MMRM) analysis of covariance with the 
change from baseline in the AISRS score at all visits following randomization as dependent 
variable, and treatment group, visit, visit-by-treatment group interaction, baseline score of 
AISRS, sex and age as fixed effects. An unstructured variance-covariance matrix will be used 
to model the within-subject errors and Satterthwaite's method will be used to approximate the 
degrees of freedom. The SAP will describe alternatives in case of non-convergence obtained 
by analyzing any multiply imputed idem. 
Sensitivity analyses will be performed as follows: 
●
Assuming that subjects on active treatment with any missing data follows the distribution
of the placebo responses.
●
Assuming that subjects on active treatment with any missing data perform worse than
MAR by a penalty.
The details of the primary and sensitivity analysis methods will be specified in the SAP. 
13.6.3. 
Handling of missing/potentially biased values 
Missing/potentially biased data will be imputed using a multiple imputation approach assuming 
that the missingness mechanism can be retrieved from observed data. The imputation model 
will include the longitudinal sequence of AISRS Scores, and the covariates used in the model 
as appropriate. 
Depending on the IE causing the missing or potentially biased value, for: 
●
Intake or change in concomitant medications/therapies which have potential confounding
effects
●
Intake of prohibited medications/therapies
●
Other IEs leading to treatment/study discontinuation (except those related to COVID-19
pandemic.


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The data recorded after the IE will be imputed/substituted under a MNAR assumption by 
borrowing information from the placebo arm subjects (reference-based imputation). 
For: 
●
IEs related to COVID-19 pandemic and other intercurrent missing data
Missing data will be imputed under a MAR assumption, borrowing information from subjects 
in the same treatment arm. 
The full detailed information about the multiple imputation algorithms will be specified in the 
SAP. 
13.6.4. 
Sample size determination 
Randomizing 26 subjects per arm, if the true efficacy of MM-120 reaches a standardized mean 
improvement over placebo of 0.60, the null hypothesis that active is not better than placebo will 
be rejected with a one-sided p-value < 0.10 with 80% power.  
The minimum estimated standardized effect size resulting in a p-value < 0.10 is 0.38 while an 
estimated standardized effect size < 0.56 will result in a one-sided p-value < 0.025. 
13.6.5. 
Secondary efficacy endpoints 
13.6.5.1 
Key secondary efficacy endpoint 
The change from baseline to Week 1 in AISRS Score will be analyzed using the same process 
as the primary endpoint. The outcome will be considered confirmatory, if in agreement with the 
primary endpoint outcome and provided that the null hypothesis is rejected for the primary 
outcome. This gatekeeping function of the primary outcome allows to avoid any adjustment for 
multiplicity of testing. 
13.6.5.2 
Other secondary and exploratory efficacy endpoints 
Change from baseline to Week 1 and 6 in AISRS, CGI-S, ASRS, and CAARS, as well as sleep 
quality score and duration, will be analyzed descriptively reporting by treatment: n, mean, 
standard deviation, Q1 (25th percentile), Q3 (75th percentile), minimum, and maximum, and 
95% Confidence Interval for the mean and for the median. Similar statistics will be reported for 
the difference from placebo. The occurrence of 1-point improvement from baseline to Week 1 
and 6 in CGI-S will be reported by a frequency table with proportions in each arm and by 
proportions' difference and ratio with relevant 95% Confidence Intervals. 
For the sleep quality score and sleep duration the endpoint will be measured as the change from 
the mean of the 7 days preceding treatment to the 7 days preceding the relevant visit (Weeks 1 
and 6). 
13.6.6. 
Subgroup analyses 
Analyses of the primary/secondary endpoints within subpopulations will be performed with 
exploratory purpose. 


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13.6.7. 
Safety analyses 
No statistical inference on safety parameters is planned. 
13.6.7.1 
Adverse events 
The verbatim terms used in the eCRF by investigators to identify adverse events will be coded 
using the Medical Dictionary for Regulatory Activities (MedDRA). Intervention-emergent 
adverse events are adverse events with onset after the intervention phase or that are a 
consequence of a pre-existing condition that has worsened since treatment start. All reported 
adverse events will be included in the analysis. For each adverse event, the percentage of 
subjects who experience at least one occurrence of the given event will be summarized by 
treatment arm. In addition, comparisons between intervention groups will be provided as 
appropriate. 
Summaries, listings, datasets, or subject narratives may be provided, as appropriate, for those 
subjects who die, or who experience a severe or a serious adverse event. 
13.6.7.2 
Other safety parameters 
Safety outcomes, including vital signs, laboratory parameters' values, ECG parameters and 
abnormalities, will be reported by treatment arm. All safety data (scheduled and unscheduled) 
will be presented in the data listings. Continuous variables will be summarized using descriptive 
statistics (n, mean, SD, minimum, median, and maximum) by treatment/dose group at relevant 
timepoints. Categorical variables will be summarized in frequency tables (frequency and 
proportion) by treatment/dose group at relevant timepoints. Graphical presentations will be used 
as appropriate. 
Where applicable, data will be summarized for the absolute value at each scheduled assessment 
and for the corresponding change from baseline. For clinical laboratory tests, listings of values 
for each subject will be presented with abnormal or out-of-range values flagged. The percentage 
of subjects with values beyond clinically important limits will be summarized by frequency 
tables and shift tables.  
Treatment emergent ECG abnormalities will be summarized similarly to AEs. 
13.6.8. 
Pharmacodynamics 
Pharmacodynamics data will be analyzed descriptively reporting by dose: n, mean, standard 
deviation, Q1 (25th percentile), Q3 (75th percentile), minimum, and maximum, and 95% 
Confidence Interval for the mean and for the median.  
14.
IMPORTANT MEDICAL PROCEDURES TO BE FOLLOWED BY
THE INVESTIGATOR
14.1 Medical Emergencies and Contacts 
The Investigator is responsible for ensuring that procedures and expertise are available to 
handle medical emergencies during the study. A medical emergency usually constitutes a SAE 


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and is to be reported as such. In the case of a medical emergency, the Investigator may contact 
the Sponsor’s physician. 
Name 
Role in the Study 
Contact details 
 
 
 
 
 
 
 
 
14.2 Overdose 
In the event of an overdosage, the subject should be monitored closely and treated 
symptomatically. Use of IMP in doses in excess of that specified in the protocol should not be 
recorded in the eCRF system as an AE of "Overdose” unless there are associated symptoms or 
signs. The associated symptoms or signs will be the AE terms documented in the source 
documents. An overdose with associated SAE(s) must be recorded as the SAE 
diagnosis/symptoms on the relevant AE forms in the source documentation and eCRF only. An 
overdose with associated nonserious AEs must be recorded as the AE diagnosis/symptoms on 
the relevant AE forms in the source documentation and in the eCRF. Only overdoses of IMP 
will be reported. 
14.3 Pregnancy 
All pregnancies and their subsequent outcome (spontaneous miscarriage, elective termination, 
ectopic pregnancy, normal birth, or congenital abnormality) should be reported to the Sponsor. 
Pregnancy is not considered to be an SAE. 
14.4 Maternal Exposure 
Women of childbearing potential must use an effective means of birth control (e.g., double-
barrier method). Should a pregnancy still occur, it should be reported to the Sponsor’s Medical 
Monitor and to the local EC as required. If a subject becomes pregnant during the study from 
Day 1/Dosing Session through Week 6, she is required to withdraw from the study. If a female 
sexual partner of a male subject becomes pregnant (by the male subject) within Day 1/Dosing 
Session through Week 6, and if the subject agrees, the subject’s pregnant partner should be 
notified. A completed ICF allows release of information, permitting transfer of information 
regarding the pregnancy and outcome to the Sponsor’s Medical Monitor. The Investigator must 
inform the subject of their right to receive treatment information. If the pregnant subject (or 
pregnant female partner of the subject) chooses to receive unblinded treatment information, the 
individual blind should be broken, and the treatment assignment provided to the 
subject/subject’s partner. The study team will remain blinded to the subject’s (partner’s) 
treatment assignment. If she agrees, the Investigator should notify the subject’s (partner’s) 
primary care physician of the pregnancy and provide details of the subject’s participation in the 
study and treatment (blinded or unblinded, as applicable). 


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Pregnancy is to be reported to the Sponsor’s Medical Monitor and drug safety and 
pharmacovigilance (PV) within 24 hours of awareness by the study site personnel, using the 
pregnancy reporting forms and the contact information in Section 14.1. The expected date of 
delivery or expected date of the end of the pregnancy, last menstruation, estimated conception 
date, pregnancy result, neonatal data, etc. should be included in this information, as available. 
The Investigator will follow the medical status of the mother, as well as the fetus, and will 
report the outcome to the Sponsor’s Medical Monitor. 
14.5 Paternal Exposure 
Pregnancy of a subject’s partner is not considered to be an SAE. However, any conception 
occurring from the date of dosing until 3 months after dosing should be reported to the Sponsor 
and followed. 


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15.
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4. APPENDICES
Appendix 1 
LIST OF PROHIBITED MEDICATIONS, SUPPLEMENTS, AND 
OTHER THERAPIES 
Drug Class or Drug Name 
Washout Conditions/ 
Prohibition Period a  
Allowable Conditions for use 
during study  
Benzodiazepines 
Last dose must have been taken at 
least 5 half-lives prior to Day -1 
/baseline  
To treat anxiety during study at 
Investigator’s discretion b  
Lithium 
Last dose must have been taken at 
least 7 days prior to Day -1 
/baseline  
None 
Monoamine oxidase inhibitors 
(MAOIs)c  
Last dose must have been taken at 
least 3 weeks prior to Day-1 
/baseline  
None 
Antipsychotics – traditional  
Antipsychotics – atypical  
Atypical agents (e.g., bupropion, 
mirtazapine)  
Barbiturates  
Selective serotonin reuptake 
inhibitors (SSRIs). For fluoxetine 
and its active metabolite, 
norfluoxetine, half-life (T1/2) of 
metabolite is more extended than 
other SSRIs and T1/2 of 7 to 15 
days should be allowed.  
Serotonin-norepinephrine 
reuptake inhibitors (SNRIs)  
Serotonin–norepinephrine– 
dopamine reuptake inhibitors 
(SNDRIs)  
Serotonin modulators (e.g., 
vortioxetine, trazodone)  
Tricyclic antidepressants (TCAs)  
Stimulants to treat AHD (e.g., 
methylphenidate hydrochloride, 
amphetamines)  
Non-stimulants to treat ADHD  
Last dose must have been taken at 
least 5 half-lives prior to Day -
1/baseline  
None 
Other medications, e.g., efavirenz, 
supplements, herbal treatments, or 
therapeutics that affect 
serotonergic function (e.g., ginkgo 
biloba, St. John’s Wort, 5-
hydroxytryptophan [5- HTP], 
ayahuasca, dimethyltryptamine 
[DMT], and opioids, in particular, 
tramadol, ketamine, 
Last dose must have been taken at 
least 5 half-lives prior to Day -
1/Baseline  
None 


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dextromethorphan, meperidine, 
methadone, and other agents that 
inhibit the reuptake of serotonin) 
a.
Subjects on prohibited medications, supplements, or other therapeutics at the time of Screening
may taper off that substance(s) prior to Day -1/Baseline (Visit 2) and will be eligible to participate
in the study if the required washout conditions have been met.
b.
Benzodiazepines should only be offered and administered if non-pharmacological interventions
(e.g., reassurance, verbal communication) do not adequately address severe anxiety symptoms.
c.
Although the half-life of MAOIs is typically 1.5-4 hours (eliminated quickly), the irreversible
inhibition of monoamine oxidase may persist for 2-3 weeks due to the requirement for de novo
synthesis of new enzyme, which is a relatively slow process. Therefore, washout for any MAOI
should be conservatively 3 weeks.


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Appendix 2 
DEFINITION OF WOMEN OF CHILDBEARING POTENTIAL AND 
ACCEPTABLE HIGHLY EFFECTIVE METHODS OF 
CONTRACEPTION 
Definition of Women of Childbearing Potential (WOCBP) 
A woman of childbearing potential (WOCBP) is defined as a woman (or non-
binary/transgender individual) who is physiologically capable of becoming pregnant. 
Women are considered to be not of childbearing potential if they meet at least one of the 
following conditions: 
●
Has undergone total hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or
bilateral tubal ligation at least 2 months prior to Screening
●
Has a congenitally absent uterus
●
Is postmenopausal, confirmed as being age > 45 years with one of the following:
o
At least 1 year without menses prior to Screening
o
6 months to < 1 year without menses prior to Screening and serum FSH levels
> 40 mIU/mL at Screening.
Acceptable Highly Effective Methods of Contraception 
Highly effective birth control methods are methods that can achieve a failure rate of less than 
1% per year when used consistently and correctly. The following highly effective methods of 
contraception are acceptable for use by WOCBP: 
●
Oral, injected or implanted hormonal methods of contraception
o
Combined estrogen and progestogen hormonal contraception (oral, intravaginal,
transdermal) associated with inhibition of ovulation; these should be initiated at least
3 months prior to Screening
o
Progestogen-only hormonal contraception (oral, injectable, implantable) associated
with inhibition of ovulation; these should be initiated at least 3 months prior to
Screening
●
Established intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) (in
place for at least 2 months prior to Screening)
●
Surgical sterilization (hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or
bilateral tubal ligation at least 2 months prior to Screening)
●
Sexual activity is limited to a male partner who has undergone effective surgical
sterilization provided that partner is the sole sexual partner of the female study subject
●
Heterosexual abstinence is only considered a highly effective method if abstinence is
defined as refraining from heterosexual intercourse for a period that covers the entire period
of potential drug and drug effect exposures. As such, the effectiveness of sexual abstinence
needs to be evaluated in relation to the duration of the clinical study, the duration of drug
effects, and the preferred and usual lifestyle of the participant. In the case of this study,


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minimum time adherence prior to first dosing is 3 months, and must continue for 3 months 
after dosing. 
Unacceptable Methods of Contraception 
Periodic abstinence (calendar, “symptothermal”, and post-ovulation methods), withdrawal 
(coitus interruptus), spermicides only and lactational amenorrhea method are not acceptable 
methods of contraception. A female condom and male condom should not be used together. 




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5. DETAILED SUMMARY OF PROTOCOL CHANGES 
 
Protocol Title: Safety and efficacy of repeated low dose D-LYSERGIC ACID DIETHYLAMIDE (LSD) D-TARTRATE (MM-120) as treatment 
for ADHD in adults: a multi-center, randomized, double-blind, placebo-controlled Phase 2a Proof of Concept Trial 
 
Version Number 
Version Date 
Current Approved Protocol 
4 
04-JUN-2021 
Amended Protocol 
5 
09-MAR-2022 
 
Section and page numbers are references to the amended full protocol (redline version). The protocol synopsis was updated to reflect all changes 
accordingly. 
Section 
Number 
Page 
Number 
Rationale for Change 
Old Text 
New Text 
All 
 
Clarification of IP name 
LSD 
MM-120 (D-lysergic acid diethylamide [LSD] D-tartrate) 
All 
 
Updated 
protocol 
to 
reflect 
the 
use 
of 
electronic case report 
forms 
CRF 
eCRF 
3.1 
Overall 
Study Design 
26 
Clarification of subject 
discontinuation 
and 
study 
enrollment 
termination 
(text added) 
Subjects are free to discontinue the study at any time without 
providing a reason. However, the Investigator should try to identify 
the reason and document in the eCRF. 
Specific reasons for discontinuing from the study should be 
documented in the eCRF, and include, but are not limited to: 
● 
Subject’s decision   


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● 
The Investigator or Sponsor judges that it is in the best interest of 
the subject to stop study treatment due to any abnormality 
compromising subject safety 
● 
Pregnancy 
● 
Severe noncompliance to the study protocol as judged by the 
Investigator and/or the Sponsor. 
Subjects who prematurely discontinue may be replaced, per Sponsor 
decision. Subjects will not be allowed to re-enter the study. 
The study will stop enrolling subjects once 26 subjects per arm are 
randomized, or if the Investigator or the Sponsor judges that it is in the 
best interest of the subjects to stop study enrollment due to low accrual 
or safety or other reason. Subjects who have given informed consent 
and have not yet been excluded, completed, or terminated from the 
study will be allowed to continue in the study. An evaluable subject is 
defined as a randomized subject (as defined in the Statistical Analysis 
Plan [SAP]). 
3.1.1 
Screening 
and Baseline 
Visits 
27 
Clarification 
of 
Baseline visit procedure 
The 
study 
comprises 
a 
screening visits (up to 4 
weeks prior to Baseline) at 
which the assessment will 
be made to confirm or make 
the ADHD diagnosis with the 
Mini 
International 
Neuropsychiatric Interview 
(MINI).  The patient must 
have an AISRS score of ≥  26 
and a CGI-S of≥  4 at 
screening and must meet all 
other eligibility criteria 
Potential study subjects who provide informed 
consent will have eligibility evaluated/confirmed 
at 2 visits. The study comprises a screening visit 
(up to 4 weeks prior to Baseline) at which the 
assessment will be made to confirm or make the 
ADHD diagnosis with the Mini International 
Neuropsychiatric Interview (MINI). The subject 
must have an AISRS score of ≥ 26 and a CGI-S of≥ 4 
at screening and must meet all other eligibility 
criteria. The baseline visit will occur on the 
clinic day before Day 1 and will confirm AISRS 
score. If there is a ≥ 13-point change in the AISRS 
between the screening visit assessment and the 
baseline assessment, or if the subject does not 
return for the baseline AISRS, the subject will not 
be randomized, and will be terminated from the 
study. Eligible subjects will be randomized at Day 
1 to either 20 μg of MM-120 or to matching placebo 


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and begin the double-blind treatment period on 
Day 1. 
3.2.2 
Secondary 
Endpoints 
28-29 
Clarification 
of 
secondary 
endpoints 
(Safety and PK) 
(text added) 
Safety endpoints 
● 
Vital signs (supine blood pressure, body temperature, heart rate, 
respiratory rate)  
● 
12-lead safety ECG 
● 
Adverse events (e.g., psychological and/or physiological adverse 
events)  
● 
Columbia-Suicide Severity Rating Scale (C-SSRS) 
● 
Safety laboratory evaluation and Urine pregnancy testing 
Pharmacokinetic endpoints 
● 
Blood samples for PK evaluation will be collected for 6 hours 
after the administration of the IMP on day 1.  
● 
Cmax 
● 
Tmax 
● 
AUC 
● 
T1/2 
Acute effects (Pharmacodynamic) endpoints 
● 
5 Dimensions of Altered States of Consciousness scale (5D-
ASC),  
● 
Mystical Experience Questionnaire (MEQ),  
drug effect Visual Analog Scale (VAS) 
3.2.3 
Exploratory 
Endpoints 
29 
Added new exploratory 
endpoint  
(added text) 
● Sleep quality/ duration rating will be evaluated based 
on daily diary entries and details of the analysis will 
be included in the SAP. 
4.1 Inclusion 
Criteria 
29-30 
Added new inclusion 
criteria #1: ability to 
understand 
informed 
consent 
(text added) 
1.Ability and willingness to provide written, informed consent prior 
to initiation of any study-related procedures and to adhere to all 
study requirements. 
NOTE: The subject (i.e., not a legally authorized representative) 
must be cognitively able to understand the requirements of the study 
and provide the informed consent. 


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4.1 Inclusion 
Criteria 
29 
Clarification 
of 
old 
inclusion criteria #1: 
study eligibility is not 
limited 
to 
binary 
genders 
1.Male 
and 
female 
outpatients ≥18 and ≤65 
years of age. 
2.Age ≥ 18 and ≤ 65 years at Screening. 
4.1 Inclusion 
Criteria 
30 
Deletion 
of 
old 
inclusion criteria #5 due 
to redundancy 
5.Able 
to 
understand 
the 
study 
procedures 
and 
understand 
risks 
associated with the study, and sign 
written informed consent to participate 
in the study 
(deleted text) 
4.1 Inclusion 
Criteria 
30 
Clarification 
of 
old 
inclusion criteria #6: 
safety monitoring 
6.Must be willing to receive IMP dose 
twice weekly and come to the clinic 
with a caregiver, or be willing to take a 
taxi home and not to drive a car or use 
heavy 
equipment 
or 
any 
other 
dangerous activity for the remainder of 
the day after receiving IMP (note: at 
protocol visits when no blood draws 
are required, the IMP may be brought 
to the patient’s home by one of the 
study investigators and administered at 
home under supervision followed by 
the 
performance 
of 
the 
same 
procedures done at the clinic). 
6.Must be willing to receive IMP dose twice weekly. On Day 1, the 
subject will come to the clinic and must be willing to take a taxi or 
public transportation home or be accompanied by a caregiver and not 
drive a car, use heavy equipment, or participate in any other dangerous 
activity for the remainder of the day after receiving IMP (NOTE: At 
any protocol visit after Day 1 dosing, dosing visits may occur at the 
subject’s home at the discretion of the PI, conducted by one of the 
study Investigators or delegate and administered under supervision 
followed by the performance of the same procedures done at the clinic 
including safety monitoring. If early withdrawal is considered due to 
any safety issue identified, the Sponsor’s medical monitor should be 
notified. If a remote visit is conducted due to any reason related to the 
COVID-19 pandemic, notification must be sent to the Medical 
Monitor’s dedicated email address and Urgent Safety Measures as 
outlined in this protocol must be followed) 
4.1 Inclusion 
Criteria 
30 
Clarification of time 
period in old inclusion 
criteria #7 
7.Must be willing to refrain from more 
than 6 standard alcoholic drinks per 
week (1 standard drink corresponds to 
0.1 L wine, 0.3 L beer, or 4 cL liquor), 
more than 10 cigarettes a day, and 
more than 2 cups of coffee a day 
7.Must be willing to refrain from more than 6 standard alcoholic 
drinks per week (1 standard drink corresponds to 0.1 L wine, 0.3 L 
beer, or 4 cL liquor), more than 10 cigarettes a day, and more than 2 
cups of coffee a day throughout the study treatment period (6 weeks) 
and until the last study visit is complete (EoS or ET). 
4.2 Exclusion 
Criteria 
30 
Added 
exclusion 
criteria 
#3: 
other 
psychiatric disorders 
(text added) 
3.Other current psychiatric disorders that, in the opinion of the 
Investigator or medical supervisor, may confound the results of the 
study (e.g., obsessive-compulsive disorder, dysthymic disorder, panic 
disorder, dissociative disorder, anorexia nervosa or bulimia nervosa) 


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4.2 Exclusion 
Criteria 
30 
Clarification 
of 
old 
exclusion criteria #4: 
liver disease exclusion 
criteria 
4.Somatic disorders including Central 
Nervous System (CNS) involvement 
of 
cancer, 
severe 
cardiovascular 
disease, untreated hypertension, severe 
liver disease (liver enzyme increase by 
more than 3x the upper limit of normal, 
except for Gilbert’s disease which 
allows 5x) or severely impaired renal 
function 
(estimated 
creatinine 
clearance < 30 mL/min by Cockroft 
and Gault calculation or CKD-EPI) or 
anything other that in the judgment of 
the investigator poses too great a 
potential for side effects. 
5.Somatic disorders including Central Nervous System (CNS) 
involvement of cancer, severe cardiovascular disease, untreated 
hypertension, severe liver disease (liver enzyme increase by more than 
3x the upper limit of normal except unconjugated hyperbilirubinemia 
due to Gilbert’s Disease, per Investigator), severely impaired renal 
function (estimated creatinine clearance < 50 mL/min by CKD-EPI 
formula), or anything else that, in the judgment of the Investigator or 
medical supervisor, poses too great a potential for side effects. 
4.2 Exclusion 
Criteria 
30-31 
Clarification 
of 
old 
exclusion criteria #7: 
ADHD medications 
7.Not willing or able to stop any 
prescription 
or 
non-prescription 
ADHD medications during the 21 days 
prior to the screening visit. 
8.Once consent is signed, subject not willing or safely able to stop any 
prescription or non-prescription ADHD medications during screening 
and prior to the baseline visit through final study visit (EoS or ET). A 
list of prohibited medications is provided in Appendix 1. 
4.2 Exclusion 
Criteria 
31 
Deleted old exclusion 
criteria #8 (included as 
part 
of 
updated 
exclusion criteria #8); 
Added new exclusion 
criteria #9 for prohibited 
medications 
8.Likely to need use of ADHD 
medications in the next 8 weeks, at the 
discretion of the investigator. 
9.Plan to start, stop, or alter the use of any medications, supplements, 
or other therapeutics from Baseline until the EoS or ET (see Appendix 
1 for list of prohibited medications). 
4.2 Exclusion 
Criteria 
31 
Added 
exclusion 
criteria #10: prohibited 
therapy 
(added text) 
10.Plan to start, stop or alter the use of psychotherapy, massage, 
meditation, 
acupuncture, 
hypnosis, 
yoga, 
or 
other 
similar 
therapy/activity from the time of providing informed consent until EoS 
or ET. 
4.2 Exclusion 
Criteria 
31 
 
 
 
 
 
 
 
4.2 Exclusion 
Criteria 
31 
Clarification 
of 
old 
exclusion criteria #9: 
prohibited 
psychiatric 
medications 
9.Likely to need use of any psychiatric 
medications in the next 8 weeks, at the 
discretion of the investigator. 
12.Likely to need any psychiatric medications with the potential to 
confound interpretation of study results or impact safety, at the 
discretion of the Investigator, in the next 10 weeks up to EoS or ET 
(see Appendix 1 for list of prohibited medications). 


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4.2 Exclusion 
Criteria 
31 
Clarification 
of 
old 
exclusion criteria #10: 
investigational 
medication 
prior 
to 
screening 
10.Use 
of 
investigational 
medication/treatment 
 
 to the screening visit per the 
discretion of the investigator. 
13.Use of investigational medication/treatment in the 
 
to the screening visit. 
4.2 Exclusion 
Criteria 
31 
 
 
 
 
 
 
 
 
 
4.2 Exclusion 
Criteria 
31 
Deleted 
Exclusion 
criteria 
related 
to 
marijuana use. 
12.Subjects who use marijuana or CBD 
for any reason within 
 
o the screening visit and during 
the study up to EoS or ET. 
(deleted text) 
4.2 Exclusion 
Criteria 
31 
Clarification 
of 
old 
exclusion criteria #13: 
clinical labs 
13.Clinically significant abnormal 
baseline laboratory values which 
include the following: 
a. values > 20% above the 
upper range of the 
laboratory standard of a 
basic metabolic screen that 
are clinically significant 
(except for liver and renal 
function parameters noted 
above). 
b. exclusionary blood 
pressure: > 140 mm Hg 
(systolic) or >90 mm Hg 
(diastolic) 
c. exclusionary ECG 
parameters: QTC 
> 450 msec (men), 
470 msec (female), QRS 
> 120 msec, and PR 
15.Clinically significant abnormal baseline laboratory values, VSs, 
and ECG that include the following: 
a. 
Have evidence of clinically significant hepatic disorder (e.g., 
alanine aminotransferase [ALT] or aspartate aminotransferase 
[AST] > 3X ULN (except for Gilbert’s disease), and  
b. Any clinically significant abnormal metabolic or hematologic 
screen, per Investigator or medical supervisor decision 
c. 
Exclusionary blood pressure: > 140 mm Hg (systolic) or > 90 mm 
Hg (diastolic); heart rate < 45 beats/minute or > 90 beats/minute 
after an approximately 5-minute supine or semi-supine rest 
NOTE: If the first measurement of a subject’s heart rate is > 90 
beats/minute, a second recording is allowed after an additional 
approximately 5-minute supine rest 
d. Exclusionary ECG parameters: QTcF > 450 msec (men), QTcF 
>470 msec (women) 
e. 
Any clinically significant abnormal electrocardiogram (ECG) 
finding (e.g., uncontrolled atrial fibrillation, ischemia) at 
Screening (Visit 1) or Baseline (Visit 2), as determined by the 
Investigator or medical supervisor (in consultation with a 
cardiologist, if needed 


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> 200 msec.  Patients 
having ECG evidence of 
ischemia or arrhythmia. 
4.2 Exclusion 
Criteria 
31-32 
Added 
exclusion 
criteria 
#17: 
other 
medical conditions 
(added text) 
16.Any other condition, therapy, laboratory abnormality, or other 
circumstance that, in the opinion of the Investigator or medical 
supervisor, may pose additional risk to the subject from participation 
in the study, may interfere with the subject’s ability to comply with 
study procedures, may make participation in the study not in the 
subject’s best interest or may confound the results of the study. 
4.2 Exclusion 
Criteria 
32 
Added 
exclusion 
criteria #18: COVID-19 
associated conditions 
(added text) 
17.Prior history or ongoing neuropsychiatric signs or symptoms 
associated with COVID-19 such as development of, or current 
disorder, during or after a COVID-19 infection including anxiety, 
memory loss, confusion, depression, delirium, agitation, or psychosis. 
4.2 Exclusion 
Criteria 
32 
Deleted old exclusion 
criteria 
#14: 
psychological 
conditions included in 
other revised EC 
14.Any condition or disease which, in 
the opinion of the investigator would 
place the patient at risk or influence the 
conduct of the study or interpretation 
of results, including (but not limited to) 
abnormally low intellectual capacity. 
(deleted text) 
4.2 Exclusion 
Criteria 
32 
Clarification 
of 
old 
exclusion criteria #16 
and addition of new 
exclusion criteria #20 
and #21: subjects with 
reproductive potential 
16.Pregnant 
or 
nursing 
females.  
Females of childbearing potential and 
not practicing an effective means of 
birth control (double-barrier method, 
i.e., 
pill/intrauterine 
device 
and 
preservative/diaphragm). 
18.Women of childbearing potential (WOCBP) (i.e., physiologically 
capable of becoming pregnant) who are unwilling or unable to use 
a highly effective method of contraception, as defined in 
Appendix 2, for the duration of the study, OR Men 
physiologically capable of fathering a child who are sexually 
active with WOCBP but are unwilling or unable to use barrier 
contraception (e.g., condom with or without spermicidal cream or 
jelly) for the duration of the study NOTE: See Appendix 2 for 
definitions of WOCBP and highly effective methods of 
contraception and for information about unacceptable methods of 
contraception. 
19.Women who are currently pregnant or breastfeeding or plan to 
become pregnant or breastfeed during the study. 
20.Men who plan to donate sperm during the study. 


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4.2 Exclusion 
Criteria 
32 
Deleted old exclusion 
criteria #18 
 
 
 
 
 
 
(text deleted) 
4.2 Exclusion 
Criteria 
32 
Clarification 
of 
old 
exclusion criteria #20: 
AISRS score 
20.Change in AISRS score of 
≥ 25% 
between 
screening 
and 
baseline visits. 
23.Subjects who have a change in AISRS score of ≥ 
13-point change between screening and baseline 
visits. 
5.1 
Subject 
Enrollment 
and 
Randomizati
on 
33 
Clarifiction 
of 
emergency 
requiring 
unblinding 
The treatment code should not be 
broken except in medical emergencies 
when the appropriate management of 
the patient requires knowledge of the 
treatment randomization. The PI will 
document and report any unblinding 
action to the sponsor.   
In case of an emergency requiring immediate knowledge of the study 
treatment and appropriate management of the subject requires 
knowledge of treatment randomization, the treatment code may be 
broken by the Investigator. The Investigator should discuss the case 
with the Sponsor’s Medical Monitor immediately after breaking the 
treatment code.  
The Sponsor’s unblinded personnel may unblind treatment assignment 
for an individual subject’s SAE in order to fulfill expedited regulatory 
requirements. 
Changes that may be implemented, if needed, due to the coronavirus 
disease 2019 (COVID-19) pandemic are described in Section 7.11 and 
a detailed impact will be included in the clinical study report (CSR). 
5.2 
Procedures 
for Handling 
Incorrectly 
Randomized 
Subjects 
33 
Added requirement to 
notify medical monitor. 
(added text) 
Sponsor’s Medical Monitor should be notified if an ineligible subject 
is dosed. 
5.5 
IMP, 
Concomitant, 
and 
Post-
study 
Treatment(s) 
34 
Clarification of at-home 
dosing 
IMP will be administered twice a 
week, every 3 to 4 days.  The IMP can 
be administered at the clinic under 
supervision of study personnel (i.e., the 
investigator or delegate).  Because 
LSD is currently a controlled substance 
with no medical use and holding of 
which would require a special license, 
the IMP cannot be provided to the 
patients to take home.  However, 
IMP will be administered twice a week, every 3 to 4 days. The IMP 
can be administered at the clinic on Day 1 or at home after Day 1 per 
PI decision under supervision of study personnel (i.e., the Investigator 
or delegate). Dosing/dispensing is based on the delegation log by 
authorized study personnel. The IMP cannot be provided to the 
subjects to take home. However, instead of administering the IMP at 
the clinic, IMP may also be brought to the subject’s home by one of 
the study Investigators or delegates on the delegation log and 
administered at home. A supportive person of the subject’s choosing 
may be present with the subject in the home. Dosing at home is not 


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instead of administering the IMP at the 
clinic, IMP may also be brought to the 
patient’s home by one of the study 
investigators 
or 
delegates 
and 
administered 
at 
home 
under 
supervision.  IMP administration at 
home 
is 
possible 
if 
both 
the 
investigator and patient consent.  This 
is not allowed on days when the patient 
must complete assessments at the 
clinic (e.g., Day 1, the 2 randomly 
selected days 
, 
the final dosing day in Week 6).  
Additionally, administration of IMP at 
home is done only after the same study 
procedures are performed as would be 
done at the clinic.  Furthermore, 
adverse effects and the use of 
concomitant medication are recorded 
by the investigator and the completion 
of the diary is checked.  Administration 
at home is mainly intended to facilitate 
trial participation for the patients and 
thereby increase study retention.  Apart 
from paracetamol/acetaminophen (not 
more than 3 g per day) if needed, no 
concomitant medication or therapy 
will be allowed that may interfere with 
the IMP.  The patient should be 
instructed that no other medication is 
allowed, including herbal remedies, 
vitamins, mineral supplements, and 
over the counter products, without the 
consent of the investigator. 
allowed on Day 1 or if protocol procedures cannot be completed at the 
home visit or under urgent safety measures per Section 7.11. 
Furthermore, adverse effects and the use of concomitant medication 
are recorded based on the delegation log by authorized study personnel 
and the completion of the diary is checked; all safety assessments will 
be obtained and AEs recorded per Schedule of Events. Administration 
at home is mainly intended to facilitate trial conduct. If a remote visit 
is conducted due to any reason related to the COVID-19 pandemic, 
notification must be sent to the Medical Monitor’s dedicated email 
address and Urgent Safety Measures as outlined in this protocol must 
be followed.  
Apart from paracetamol/acetaminophen (not more than 3 g per day) if 
needed, no concomitant medication or therapy will be allowed that 
may interfere with the IMP (see Section 5.5.1). The subject should be 
instructed that no other medication is allowed, including herbal 
remedies, vitamins, mineral supplements, and over the counter 
products, without the consent of the Investigator. 
 
(New) 5.5.1 
Prohibited 
concomitant 
medications 
35 
Added 
text 
for 
clarification 
of 
prohibited medications 
(added text) 
The use of medications, supplements, and other therapeutics (over 
the counter or prescribed) for treating attention-deficit/hyperactivity 
disorder (ADHD), anxiety, depression or mood disorders are 
prohibited from Day -1/Baseline (Visit 2) until End of Study (except 


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if needed for care and treatment of the subject during the study per 
Investigator discretion. Additionally, the use of other substances, 
herbal treatments, etc. that may confound the results of the study are 
prohibited from Day -1/Baseline (Visit 2) until End of Study (e.g., 
cannabis, cannabidiol [CBD], ginkgo biloba). Subjects must also 
avoid starting, stopping, or altering non-medicinal therapies/activities 
from the time of providing informed consent until End of Study. Any 
prohibited substance(s) being taken at the time of signing consent at 
screening (Visit 1) should be tapered prior to Day -1/Baseline (Visit 
2), if safe for the subject, in the opinion of the Investigator; tapering 
will be done with oversight from the Investigator or medical 
supervisor and in accordance with information provided in Appendix 
1 and previously provided in the clarification memo dated 09-Nov-
2021. A listing of specific restrictions for concomitant therapy use 
during the course of this study was provided, with any necessary 
washout periods or allowable conditions described. The subject must 
meet all eligibility criteria for which prohibited medication was 
prescribed, including but not limited to, psychotic disorder, bipolar 
disorder, or major depressive disorder with psychotic features OR 
any disorder that puts a subject at risk for a challenging experience, 
e.g., panic disorder. 
 
Subjects will be tested for cannabis (THC metabolite) but will not be 
excluded in case of a positive test. Subjects will be strongly advised 
and reminded against using cannabis throughout the study duration. 
 
The table in Appendix 1 provides examples; however, it is not a 
comprehensive list of all restricted medications, supplements, and 
other therapeutics. Consult the Sponsor’s Medical Monitor or 
designee if there is any uncertainty regarding a subject’s use of a 
particular drug, drug class, supplement or other therapeutic.  
 
Once an ICF is signed, subjects on prohibited medications, 
supplements, or other therapeutics may taper off that substance and 
participate in the study if the required washout conditions have been 
met. For prescribed medications to treat ADHD, anxiety, depression 
or other mood disorders, the medication taper will be overseen by the 


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treating physician or a study physician based on acceptable local 
practice standards.  
 
 
 
 
 
 
 
37 
 
 
 
 
 
 
(added text) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
5.6 
Withdrawal 
from Study 
37 
Clarification of possible 
reasons for withdrawal 
Patients may be withdrawn at any time.  
Once dosing has occurred, every 
attempt should be made to continue 
assessments to ensure the safety of the 
patient. 
Specific 
reasons 
for 
withdrawing a patient should be 
documented in the CRF, and include, 
but are not limited to: 
● 
patient’s decision.   
● 
adverse events 
● 
severe noncompliance to the 
study protocol as judged by the 
investigator and/or the sponsor 
 
Subjects may be withdrawn at any time. Once dosing has occurred, 
every attempt should be made to continue assessments to ensure the 
safety of the subject. Specific reasons for withdrawing a subject should 
be documented in the eCRF, and include, but are not limited to: 
● 
Subject’s decision   
● 
The Investigator or Sponsor judges that it is in the best interest 
of the subject to stop study treatment due to any abnormality 
compromising subject safety 
● 
Pregnancy 
● 
Severe noncompliance to the study protocol as judged by the 
Investigator and/or the Sponsor. 
Subjects who prematurely discontinue may be replaced, per Sponsor 
decision. Subjects will not be allowed to re-enter the study. 


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6.1 Schedule 
of Events 
39-42 
Clarification 
and 
modification of study 
procedures  
Figure 3 
Table 3 (updated table and footnotes in track changes): Substantial 
changes include allowing for remote (home-based) dosing visits at all 
post Day 1 study visits, clarification for Week 2 assessments (AISRS, 
CGI-S), vital signs to be assessed at every visit. 
6.2 Visits and 
Assessments 
43 
Added text to clarify 
that safety assessments 
for 
every 
visit 
are 
required. 
(text added) 
All visits must be monitored for safety and AEs recorded. 
6.2.3 Day 1 
dosing (+/-1 
day) 
43 
Clarification 
of 
procudures for day 1 
dosing visit. 
For this visit, the patient will remain at 
the testing facility for 6 hours after 
drug administration.   
Randomization to MM-120 or placebo will occur before the first dose 
on Day 1. The first dose must be administered in the clinic. For this 
visit, the subject will remain at the testing facility for 6 hours after 
drug administration for blood sampling and getting familiar with the 
effects of LSD. 
6.2.4  Post 
Day 1 dosing 
visits 
44 
Added summary of at-
home dosing visits 
(text added) 
Following Day 1 dosing, all visits may be conducted remotely per 
Investigator decision as long as all activities can be conducted per 
protocol, e.g., calibrated blood pressure cuff, cognitive scale.  
Any visit conducted remotely due to COVID-19 requires Sponsor 
Medical Monitor and operations team notification and conduct under 
urgent safety measures and all protocol deviations captured in EDC 
designated COVID-19 deviation. 
The reason for a remote visit must be captured in the EDC. The site 
will choose one of the following reasons: 
1. 
COVID-19 
2. 
Convenience for study subject 
3. 
Site space considerations to conduct in clinic visits 
4. 
Other 
6.2.4.1 Week 
1 visit 
44 
Clarification 
of 
assessments at Week 2 
(text added) 
At the first visit after 1 week of treatment (Day 8 or after), AISRS and 
CGI-S will be conducted in addition to other required study activities. 
These activities will be performed pre-dose on the 3rd dosing visit. 
6.2.4.2 Twice 
weekly 
dosing 
44 
Clarification of twice 
weekly dosing in clinic 
or at subject’s home 
Dosing 
(placebo/7.11LSD), 
record 
adverse 
events 
and 
concomitant 
medications,  C-SSRS (Since Last 
Visit), and check daily diary. 
Dosing (placebo/MM-120) is to be completed by a trained study 
personnel with delegated authority for drug dispensing/ dosing. At 
each visit, adverse events and concomitant medications will be 
recorded, vital signs, C-SSRS (Since Last Visit) administered, and 
daily diary checked. Pregnancy testing will occur predose at each 
dosing visit or a minimum of once weekly. 


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6.2.4.3 Every 
2 weeks prior 
to first dose 
of the week 
44 
Clarification of every 2 
weeks 
dosing 
and 
activities in the clinic 
Clinical laboratory tests, 
 
ASRS and CAARS-L-SR, C-
SSRS (Since Last Visit), pregnancy 
test, 
record 
adverse 
events 
and 
concomitant medications, check daily 
diary. 
 
Pharmacodynamics 
(self-
assessment by patient at home)). 
At each clinic visit that occurs every 2 weeks, clinical laboratory tests, 
ASRS and CAARS-L-SR, and pregnancy test will be conducted. Two 
 will also be conducted during the study. 
When combined with a dosing visit, regular activities scheduled to be 
conducted at each dosing visit will also be completed (see Section 
6.2.4.2). 
6.2.4.4 Week 
6 (last dose) 
44 
Clarification 
of 
activities at Week 6 visit 
(text added) 
Study activities performed before dosing: 
C-SSRS (Since Last Visit), record adverse events 
and concomitant medications, check daily diary, physical examination 
(including weight, height, calculated BMI, vital signs [body 
temperature, heart rate, supine BP, RR]), cognitive performance tests, 
clinical laboratory tests, ASRS and CAARS-L-SR, AISRS, and CGI-
S.  
Study activities performed after dosing: 
12-lead ECG conducted at 2 hours post dosing. Pharmacodynamics 
using 5D-ASC and MEQ30 at 6 hours after dosing (subject completes 
at home). 
6.2.5 
Week 
10 follow-up 
or 
End 
of 
Study/ Early 
Termination 
visit 
45 
Added summary of at-
home visit requirements 
(text added) 
The Week 10 follow-up visit may be conducted remotely per 
Investigator decision. The reason for conducting the visit remotely 
must be recorded in the EDC (as listed in Section 6.2.4), and if the 
reason is due to COVID-19, the Sponsor Medical Monitor and 
operations team must be notified and the visit conducted under urgent 
safety measures and all protocol deviations captured in the EDC. 
6.2.7 
Daily 
Diary 
45 
Revised 
purpose 
of 
daily diary for sleep 
monitoring. 
Patients rate their ADHD symptom 
severity using the CGI-S question as a 
self-rating.  Additionally, patients self-
rate the extent of adverse treatment 
effects on a 0-10 scale and indicate any 
adverse effects on a free text field.  
Finally, patients will rate how well 
they slept the preceding night on a 
scale from 0-10.   
To explore sleep quality and duration, the subjects will be given a 
home diary for recording sleep parameters. Details of the home diary 
will be described in a separate document. Analysis will be specified in 
the SAP. 
6.2.8.5 Time 
reproduction 
task 
48 
Added use of Good 
Distribution Practice 
The six time intervals (3, 6, 12, 15, 30, 
or 45 seconds) will be presented twice 
The Good Distribution Practice six-time intervals (3, 6, 12, 15, 30, or 
45 seconds) will be presented twice in random order, summing up to 
12 trials in total. 


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in random order, summing up to 12 
trials in total. 
7.2 
LSD-
Specific 
toxicity 
consideration
s 
49 
Clarification of study 
activities 
to 
be 
completed at home visit. 
For 
home 
medication, 
study 
medication under the investigator’s 
supervision may be administer at home 
to 
the 
patient 
to 
assure 
study 
medication compliance and safety and 
perform 
all 
protocol 
procedures 
including 
AE/SAE, 
concomitant 
medication, and pregnancy test. 
For home medication, study medication under the Investigator’s 
supervision may be administered at home to the subject to assure study 
medication compliance and safety and perform all protocol procedures 
including AE/SAE, concomitant medication, C-SSRS assessment, and 
daily diary check. 
7.2.4 
Reproductive 
and 
development
al risks 
50 
Added 
expanded 
information 
about 
eligibility for WOCBP 
and male subjects with 
reproductive potential 
LSD 
is 
neither 
mutagenic 
nor 
teratogenic, and its chronic use is not 
associated 
with 
birth 
defects.  
However, 
pregnant 
women 
are 
excluded from the study, and effective 
birth control will be mandatory for 
female patients, and pregnancy tests 
will be done on Day 1, every 2 weeks 
and at Week 10. 
There are mixed results from preclinical studies evaluating 
reproductive toxicity, chromosomal aberration, and mutagenic studies 
(refer to the MM-120 Investigator’s Brochure for details). Thus, to 
participate in this study, women of childbearing potential (WOCBP) 
(i.e., physiologically capable of becoming pregnant) must agree to use 
a highly effective method of contraception for the duration of the 
study, and non-sterilized men who are sexually active with a WOCBP 
must agree to use barrier contraception (e.g., condom with or without 
spermicidal cream or jelly). Subjects who do not agree to these 
conditions are not eligible to participate in the study.   
Appendix 2 provides definitions of WOCBP and highly effective 
methods of contraception as well as information about unacceptable 
methods of contraception.  Subjects will be provided with information 
on acceptable methods of contraception as part of the informed 
consent process and will confirm when they sign a consent form that 
they understand the requirements for avoidance of pregnancy in the 
subject or the subject’s sexual partner during the course of the study. 
Additional Information for Female Subjects 
WOCBP may participate in the study only if they have a negative 
urinary pregnancy test (beta human chorionic gonadotropin [β-HCG]) 
result at specified visits prior to dosing (i.e., Screening [Visit 1] and 
Day 1) and every 2 weeks during the dosing phase of the study 
(through Week 6). 
Female subjects who are currently or planning to become pregnant or 
breastfeed during the study period are excluded. If a female subject 
withdraws early from the study, she should be advised not to become 
pregnant or breastfeed for 3 months after last dose of study drug. Any 


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subject that becomes pregnant after Day 1/Dose through Week 6 is 
required to withdraw from the study. The subject will be monitored 
for the outcome of the pregnancy, and reporting will occur as 
described in Section 7.8. 
Additional Information for Male Subjects 
Male subjects should be encouraged to advise any WOCBP who are 
their sexual partners to use a highly effective method of contraception 
in addition to the male subject’s use of barrier contraception.  A female 
condom and male condom should not be used together. 
Male subjects who are planning to donate sperm during the study 
period are excluded. If a male subject withdraws early from the study, 
he should be advised not to donate sperm for at least 28 days after he 
received the study drug. 
7.4.1 Adverse 
cardiovascula
r effects 
53 
Added requirement to 
notify medical monitor 
Treatment of a hypertensive reaction 
(Psys > 220 mmHg) 
may 
include 
lorazepam 
and 
nitroglycerine. 
Treatment 
of 
hypotension 
would 
include Trendelenburg position.   
Treatment of a hypertensive reaction (Psys > 220 mmHg) may include 
lorazepam and nitroglycerine, per Investigator decision and Sponsor 
medical monitor notified. Treatment of hypotension would include 
Trendelenburg position.  
7.6.1 Adverse 
Event 
54 
Clarification 
that 
positive 
or 
negative 
symptoms should be 
reported 
An 
AE 
can 
therefore 
be 
any 
unfavorable 
and 
unintended 
sign 
(including an abnormal laboratory 
finding), 
symptom, 
or 
disease 
temporally associated with the use of 
an IMP, whether or not considered 
related to the IMP. 
An AE can therefore be any unfavorable and unintended sign 
(including an abnormal laboratory finding), or any clinically 
significant change from baseline, whether considered positive (e.g., 
marked feelings of a drug high, feeling happy) or negative symptom 
(e.g., feeling panicked, fearful, or sad), change in sleep, quality or 
duration, or disease temporally associated with the use of an IMP, 
whether or not considered related to the IMP. 
7.7 Causality 
55 
Deleted 
“Not 
assessable” 
from 
causality 
relationship 
options 
Not 
assessable 
There is insufficient 
or incomplete 
evidence to make a 
clinical judgment of 
the causal 
relationship. 
(text deleted) 
7.10.1 
Informed 
Consent 
56 
Clarification 
of 
informed 
consent 
summary 
The subject will be informed about the 
study procedures and associated risks 
both verbally and by the approved 
For this study, the subject must be cognitively able to understand the 
requirements of the study and provide the informed consent to 
participate in the study; use of a legally authorized representative to 


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written consent form. The study 
physician and the subject will both 
personally sign and date the consent 
form as confirmation of consent. 
Subjects will be provided with the 
study information before the session 
with the investigator to provide time (at 
least 1 day) to consider participation. 
There are no incentives for subjects 
who participate in the study and any 
provisions for subjects harmed as a 
consequence of study participation 
should be described in the Informed 
Consent Form (ICF) that is approved 
by an Ethics Committee (EC). 
The investigator will: 
● 
Ensure that each subject is given 
full and adequate oral and written 
information about the nature, 
purpose, possible risk, and benefit 
of the study 
● 
Ensure that each subject is 
notified that they are free to 
withdraw from the study at any 
time 
● 
Ensure that each subject is given 
the opportunity to ask questions 
and allowed time to consider the 
information provided 
● 
Ensure each subject provides 
signed and dated informed 
consent before conducting any 
procedure specifically for the 
study 
provide consent to participate is not allowed. Informed consent forms 
(ICFs), any subsequently revised written ICFs, and any written 
information provided to the subject must receive Institutional Ethics 
Committee (IEC) approval in advance of use. The subject should be 
informed in a timely manner if new information becomes available 
that may be relevant to the subject’s willingness to continue 
participation in the study. The communication of this information will 
be provided and documented via a revised main ICF or addendum to 
the original ICF that captures the subject’s dated signature. 
The ICFs will adhere to IEC requirements, applicable laws and 
regulations and Sponsor requirements. 


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● 
Ensure the original, signed ICF 
are stored in the Investigator’s 
Study File (ISF) 
● 
Ensure copies of the signed ICF 
are given to the subject. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.10.6 
Laboratory 
tests 
57 
Replaced list of clinical 
labs with reference to 
relevant section to avoid 
duplication 
A routine laboratory blood test is 
performed 
at 
the 
screening 
examination, and similarly during the 
treatment period and at the follow-up 
visit 
(see 
Schedule 
of 
Events), 
including serum creatinine, alkaline 
phosphatase, sodium, potassium, total 
bilirubin, aspartate aminotransferase 
(AST), 
alanine 
aminotransferase 
(ALT), glucose, blood urea nitrogen 
(BUN), hemoglobin, hematocrit, white 
blood cell (WBC) count, red blood cell 
(RBC) count, total platelet count and 
C-reactive protein (CRP).  In addition, 
 
 
 
 
a urine 
pregnancy test (only in women) are 
performed. 
A routine laboratory blood test will be performed at the screening 
examination, and similarly during the treatment period and at the 
follow-up visit (see Schedule of Events); see Section 8.2. In addition, 
a 
and a urine pregnancy test (only in women) are 
performed at select time points before IP dosing throughout the study; 
see Section 8.2. 
7.10.7 
Re-
Screening 
57 
Clarification 
of 
procedures 
for 
rescreening 
If the screening was performed more 
than three months before first study 
session, patients will be rescreened, 
and the baseline psychiatric measures 
repeated.  Blood chemistry tests will be 
repeated only when the interim 
medical 
history 
or 
physical 
examination suggest an abnormality.  
Screen failures are subjects who consent to participate in the clinical 
study but are never randomized. 
 
Subjects excluded during screening should promptly be reported as a 
screen failure in the electronic data capture (EDC) system. 
 
Subjects excluded during screening may be rescreened once in 
consultation with the Sponsor’s Medical Monitor, when the reason for 


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Written consent will be obtained.  
Patients may only be rescreened once. 
meeting an exclusion is likely to resolve (e.g., the subject had an 
exclusionary acute infection that is resolving, or a medication taper is 
taking longer than 28 days). If a subject is rescreened, the subject must 
be reconsented to participate in the study. 
(New) 
7.11 
Urgent Safety 
Measures 
58 
Added 
specific 
measures to follow in 
case of crisis or other 
emergency 
(text added) 
All arrangements described in this section apply only to the extent 
that protocol requirements cannot be met because of restrictions due 
to a crisis, such as the COVID-19 pandemic. Study center visits 
should take place to the extent possible and usual protocol 
requirements adopted for all subjects as soon as the crisis-related 
limitations permit. Exceptional measures taken in response to a crisis 
(e.g., COVID-19) and their impact on study results, such as tests 
done in a different local laboratory, will be explained, assessed, and 
reported in the clinical study report following ICH E3 guidance. 
 
In case any visit described in the Schedule of Events (Section 6.1) 
that is required to be conducted in-clinic and cannot be conducted at 
the study center within the visit window due to restrictions related to 
COVID-19 or another such crisis, a telephone visit, home visit and/or 
video call should be arranged. The telephone visit should include all 
protocol assessments that can be performed remotely and should take 
place within the original visit window. A home visit requires the PI 
or delegate to conduct all safety assessments and record AEs. A 
supportive person of the subject’s choosing may be present with the 
subject in the home. The decision to replace the study center visit 
with an alternate contact method will be made by the Investigator on 
a case-by-case basis, and the Sponsor’s Medical Monitor and clinical 
operations project manager should be informed of each case as early 
as possible. In addition to the remote visit, the Investigator should 
complete the following assessments/procedures: 
• Outcome clinical assessments e.g., AISRS, CGI 
• Check daily diary 
• Concomitant medication review/collection 
• Adverse event collection 
• Safety laboratory assessment (if required at that visit) 
• Urine pregnancy test (if required at that visit) 


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• 
 
• C-SSRS – SLV Version 
For scheduled visits that require additional assessments such as 
clinical laboratory measurements, the use of local practitioners and 
resources may be employed. In case these assessments cannot be 
obtained within a reasonable time after the remote visit contact, the 
benefit-risk ratio for the subject to continue in the study should be 
reassessed. 
 
All safety data that are possible to obtain locally should be collected 
at the remote visit. 
(New) 
7.12 
Special 
Situations 
59 
Added 
section 
for 
special situations 
(text added) 
Special situations with study drug are defined as the following:  
• Medication error or incorrect drug administration  
• Overdose (exceeds the protocol-specified maximum; see Section 
9.4 for the definition of overdose) 
• Deliberate abuse 
• Deliberate misuse 
• Drug interaction  
• Occupational exposure 
If any of these special situations with study drug occur, they will be 
reported on the special situations with study drug eCRF page, even if 
there is no accompanying AE. All clinical manifestations in relation 
to these special situations will be reported as AEs or SAEs at the same 
time using the corresponding section of the eCRF. 
For example, if a medication error or interaction occurred, the 
Investigator will assess whether to consider an AE to have occurred, 
and if so, will assign the possible relationship to the study drug.   
Additional information may be requested by the site including all AE 
information and all triggering drug accountability discrepancies. 
8.2.1 Clinical 
Chemistry 
59-61 
Added detailed list of 
clinical 
laboratory 
parameters 
to 
be 
assessed; 
clarification 
1. hematology: hemoglobin, 
hematocrit, total platelets count, 
white blood cell (WBC) count, 
red blood cell (RBC) count 
 
Standard Chemistry  


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that 
urinalysis 
not 
required. 
2. serum biochemistry: alkaline 
phosphatase, total bilirubin, 
serum creatinine, aspartate 
aminotransferase (AST), alanine 
aminotransferase (ALT), sodium, 
potassium, glucose, blood urea 
nitrogen (BUN), C-reactive 
protein (CRP) 
3. Urine pregnancy test 
4. 
 
5. ECG 
6. Urine 
 
Laboratory 
values 
outside 
the 
reference limit and suspected to be of 
any clinical significance will be 
repeated.  Patients who have findings 
where suspected clinical significance 
is confirmed will either not be included 
or, if already randomized, will be 
followed until normalization or for as 
long as the investigator considers 
necessary.  Additional laboratory 
variables may be performed for safety 
reasons if judged appropriate by the 
investigator. 
The samples for clinical laboratory 
tests and urinalysis will be analyzed 
using routine methods at the local 
laboratory. 
● Albumin 
● Total protein 
● Alkaline 
phosphatase 
● ALT 
● AST 
● Bilirubin, total 
(reflex direct 
bilirubin if total 
bilirubin is > ULN) 
● Blood urea nitrogen 
or urea 
● Calcium 
● Chloride 
● Creatinine 
● Creatinine clearance 
(CKD-EPI) 
● FSHa (to confirm 
postmenopausal status) 
● GGT 
● Glucose 
● Lactate dehydrogenase 
● Phosphate 
● Potassium 
● Sodium 
Hematology Complete blood count, including: 
● 
Hemoglobin 
● 
Hematocrit 
● 
Reflex RBC indices if hematocrit/hemoglobin 
are abnormal: 
o MCV 
o MCH 
● 
Platelet count 
● 
Red blood cell count 
● 
White blood cell count 


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● 
Reflex differential count if WBC is elevated, 
including: 
o Basophils 
o Eosinophils 
o Lymphocytes 
o Monocytes 
o Neutrophils 
Urine pregnancy test 
 
 
 
 
 
 
 
 
 
 


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8.2.3 Resting 
12-Lead ECG 
61 
Clarification of ECG 
findings to be recorded 
All ECGs will be documented by 
recording date, time of collection, heart 
rate, PR, RR, QRS, QT, and QTcF 
intervals from the 12-lead ECG. 
All ECGs will be documented by recording date, time of collection, 
all abnormal waveform noted, heart rate, all intervals including PR, 
RR, QRS, QT, and QTcF/QTcB intervals from the 12-lead ECG. 
8.3.1 
Collection of 
pharmacokin
etic samples 
62 
Clarification of process 
for 
collecting 
blood 
samples 
The timing and number of PK samples 
will be at 0, 0.5, 1, 2, 3, 4 and 6 hours. 
The actual date and time of collection 
of each sample will be recorded on the 
CRF. Blood samples will be collected 
in heparinized tubes, centrifuged at 
4°C at 3000 rpm for 10 min, and the 
plasma is then stored (two aliquots) at 
-20°C until shipping/analysis. During 
the PK assessment 7 x 7.5 ml= 52.5 ml 
blood will be collected in each subject. 
The timing and number of PK samples will be at 0, 0.5, 1, 2, 3, 4 and 
6 hours. The actual date and time of collection of each sample will be 
recorded on the eCRF. Samples will be collected (aliquot and back-
up) to be stored at -20°C (for the back-up) and -80°C (for the aliquot). 
Blood samples will be collected in heparinized/EDTA tubes, 
centrifuged at 4°C at 3000 rpm for 10 min, and the plasma is then 
stored at -20°C until shipping/analysis. 


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9.1 
Volume 
of Blood 
63 
Clarification 
of 
expected 
volume 
of 
blood required 
The total volume of blood that will be 
drawn from each subject in this study 
is shown below. 
Table 4: Table of Volume of Blood to 
be drawn from each subject 
Assessment 
Safety 
Clinical chemistr
 
Hematology 
PK samples 
 
Total 
 
*Maximum sample volume to be 
collected per protocol. 
The number of samples to be obtained, 
as well as the volume required for each 
analysis, may be changed during the 
study as new data becomes available. 
However, the maximum volume to be 
drawn from each subject should not 
exceed 112.5 mL. 
Blood samples for determination of plasma concentration of MM-120 
will be collected pre- and post-dose on Day 1. The sampling scheme 
and sampling duration, without exceeding the maximal sample 
number, duration, or maximal blood volume in this protocol, will be 
maintained. 
The number of samples to be obtained, as well as the volume required 
for each analysis, may be changed during the study as new data 
become available. However, the maximum volume to be drawn from 
each subject will be approximately 120 mL. 
11.1.2 
Monitoring of 
Study 
66 
Added 
details 
about 
drug accountability 
(added text) 
Each site will comply with applicable laws per each regulatory 
authority. The Investigator is responsible for ensuring compliance at 
the site with all procedures and details of drug handling, storage and 
accountability for dosing, tracking, control and return via reverse 
distributor, and prevention of unauthorized access. 
11.1.5 Study 
termination 
67 
Clarification of possible 
reasons for termination 
of study 
The study may be terminated if the 
study 
procedures 
are 
not 
being 
performed according to GCP, or if 
recruitment is slow.  The sponsor may 
also 
terminate 
the 
entire 
study 
prematurely if concerns for safety arise 
within this study. 
The study may be terminated if the study procedures are not being 
performed according to GCP, or according to the protocol, or if 
recruitment is slow. The Sponsor may also terminate the entire study 
prematurely if concerns for safety arise within this study. 


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13.6.5.2 
70 
Added 
exploratory 
endpoint 
of 
sleep 
quality and duration 
Other 
secondary 
efficacy 
endpoints 
Change from baseline to Week 1 and 6 
in AISRS, CGI-S, ASRS, and CAARS 
will 
be 
analyzed 
descriptively 
reporting by dose: n, mean, standard 
deviation, Q1 (25th percentile), Q3 
(75th 
percentile), 
minimum, 
and 
maximum, 
and 
95% 
Confidence 
Interval for the mean and for the 
median. For the active doses similar 
statistics will be reported for the 
difference 
from 
placebo. 
The 
occurrence of 1-point improvement 
from baseline to Week 1 and 6 in CGI-
S will be reported by a frequency table 
with proportions in each arm and by 
proportions' difference and ratio with 
relevant 95% Confidence Intervals. 
Other secondary and exploratory efficacy endpoints 
Change from baseline to Week 1 and 6 in AISRS, CGI-S, ASRS, and 
CAARS, as well as sleep quality score and duration, will be analyzed 
descriptively reporting by treatment: n, mean, standard deviation, Q1 
(25th percentile), Q3 (75th percentile), minimum, and maximum, and 
95% Confidence Interval for the mean and for the median. Similar 
statistics will be reported for the difference from placebo. The 
occurrence of 1-point improvement from baseline to Week 1 and 6 in 
CGI-S will be reported by a frequency table with proportions in each 
arm and by proportions' difference and ratio with relevant 95% 
Confidence Intervals. 
For the sleep quality score and sleep duration the endpoint will be 
measured as the change from the mean of the 7 days preceding 
treatment to the 7 days preceding the relevant visit (Weeks 1 and 6). 
14.1 
72 
Added Sponsor Medical 
Monitor and specified 
2nd, 
GCP 
Medical 
Monitor, with contact 
information 
(added text) 
 
 
14.3 
Pregnancy 
73 
Clarified that pregnancy 
is not an SAE 
(added text) 
Pregnancy is not considered to be an SAE. 
14.4 Maternal 
Exposure 
73 
Clarification 
of 
reporting requirements 
for pregnant subject 
Women of childbearing potential must 
use an effective means of birth control 
(e.g., double-barrier method).  Should 
a pregnancy still occur, it should be 
reported to the sponsor and to the local 
EC as required. 
Women of childbearing potential must use an effective means of 
birth control (e.g., double-barrier method). Should a pregnancy still 
occur, it should be reported to the Sponsor’s Medical Monitor and to 
the local EC as required. If a subject becomes pregnant during the 
study from Day 1/Dosing Session through Week 6, she is required to 
withdraw from the study. If a female sexual partner of a male subject 
becomes pregnant (by the male subject) within Day 1/Dosing 
Session through Week 6, and if the subject agrees, the subject’s 
pregnant partner should be notified. A completed ICF allows release 
of information, permitting transfer of information regarding the 


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pregnancy and outcome to the Sponsor’s Medical Monitor. The 
Investigator must inform the subject of their right to receive 
treatment information. If the pregnant subject (or pregnant female 
partner of the subject) chooses to receive unblinded treatment 
information, the individual blind should be broken, and the treatment 
assignment provided to the subject/subject’s partner. The study team 
will remain blinded to the subject’s (partner’s) treatment assignment. 
If she agrees, the Investigator should notify the subject’s (partner’s) 
primary care physician of the pregnancy and provide details of the 
subject’s participation in the study and treatment (blinded or 
unblinded, as applicable). 
 
Pregnancy is to be reported to the Sponsor’s Medical Monitor and drug 
safety and pharmacovigilance (PV) within 24 hours of awareness by 
the study site personnel, using the pregnancy reporting forms and the 
contact information in Section 14.1. The expected date of delivery or 
expected date of the end of the pregnancy, last menstruation, estimated 
conception date, pregnancy result, neonatal data, etc. should be 
included in this information, as available. The Investigator will follow 
the medical status of the mother, as well as the fetus, and will report 
the outcome to the Sponsor’s Medical Monitor. 
Appendix 1 
82 
Added 
List 
of 
prohibited medications 
for reference 
(added text) 
 
Drug Class or Drug 
Name  
Washout 
Conditions/  
Prohibition 
Perioda  
Allowable 
Conditions 
for use during 
study  
Benzodiazepines  
Last dose must 
have been taken at 
least 5 half-lives 
prior to Day -1 
/baseline  
To treat 
anxiety during 
study at 
Investigator’s 
discretionb  
Lithium  
Last dose must 
have been taken at 
least 7 days prior 
to Day -1 /baseline  
None  
Monoamine oxidase 
inhibitors (MAOIs)c  
Last dose must 
have been taken at 
None  


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least 3 weeks prior 
to Day-1 /baseline  
Antipsychotics – 
traditional  
Antipsychotics – 
atypical  
Atypical agents (e.g., 
bupropion, 
mirtazapine)  
Barbiturates  
Selective serotonin 
reuptake inhibitors 
(SSRIs). For fluoxetine 
and its active 
metabolite, 
norfluoxetine, half-life 
(T1/2) of metabolite is 
more extended than 
other SSRIs and T1/2 
of 7 to 15 days should 
be allowed.  
Serotonin-
norepinephrine 
reuptake inhibitors 
(SNRIs)  
Serotonin–
norepinephrine– 
dopamine reuptake 
inhibitors (SNDRIs)  
Serotonin modulators 
(e.g., vortioxetine, 
trazodone)  
Tricyclic 
antidepressants (TCAs)  
Stimulants to treat 
AHD (e.g., 
methylphenidate 
Last dose must 
have been taken at 
least 5 half-lives 
prior to Day -
1/baseline  
None  


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hydrochloride, 
amphetamines)  
Non-stimulants to treat 
ADHD  
Other medications, e.g., 
efavirenz, supplements, 
herbal treatments, or 
therapeutics that affect 
serotonergic function 
(e.g., ginkgo biloba, St. 
John’s Wort, 5-
hydroxytryptophan [5- 
HTP], ayahuasca, 
dimethyltryptamine 
[DMT], and opioids, in 
particular, tramadol, 
ketamine, 
dextromethorphan, 
meperidine, 
methadone, and other 
agents that inhibit the 
reuptake of serotonin)  
Last dose must 
have been taken at 
least 5 half-lives 
prior to Day -
1/Baseline  
None  
aSubjects on prohibited medications, supplements, or other 
therapeutics at the time of Screening may taper off that 
substance(s) prior to Day -1/Baseline (Visit 2) and will be 
eligible to participate in the study if the required washout 
conditions have been met.  
bBenzodiazepines should only be offered and administered if 
non-pharmacological interventions (e.g., reassurance, verbal 
communication) do not adequately address severe anxiety 
symptoms.  
cAlthough the half-life of MAOIs is typically 1.5-4 hours 
(eliminated quickly), the irreversible inhibition of monoamine 
oxidase may persist for 2-3 weeks due to the requirement for de 
novo synthesis of new enzyme, which is a relatively slow 
process. Therefore, washout for any MAOI should be 
conservatively 3 weeks.  


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Appendix 2 
83 
Definition of women of 
childbearing 
potential 
and acceptable highly 
effective methods of 
contraception 
(added text) 
Definition of Women of Childbearing Potential 
(WOCBP) 
A woman of childbearing potential (WOCBP) is defined as a woman 
(or non-binary/transgender individual) who is physiologically capable 
of becoming pregnant. 
Women are considered to be not of childbearing potential if they meet 
at least one of the following conditions: 
• Has undergone total hysterectomy, bilateral salpingectomy, 
bilateral oophorectomy, or bilateral tubal ligation at least 2 
months prior to Screening  
• Has a congenitally absent uterus 
• Is postmenopausal, confirmed as being age > 45 years with one 
of the following: 
o At least 1 year without menses prior to Screening 
o 6 months to < 1 year without menses prior to Screening and 
serum FSH levels > 40 mIU/mL at Screening. 
Acceptable Highly Effective Methods of 
Contraception 
Highly effective birth control methods are methods that can achieve a 
failure rate of less than 1% per year when used consistently and 
correctly. The following highly effective methods of contraception are 
acceptable for use by WOCBP: 
• Oral, injected or implanted hormonal methods of contraception 
o Combined estrogen and progestogen hormonal 
contraception (oral, intravaginal, transdermal) associated 
with inhibition of ovulation; these should be initiated at 
least 3 months prior to Screening 


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o Progestogen-only hormonal contraception (oral, injectable, 
implantable) associated with inhibition of ovulation; these 
should be initiated at least 3 months prior to Screening 
• Established intrauterine device (IUD) or intrauterine hormone-
releasing system (IUS) (in place for at least 2 months prior to 
Screening) 
• Surgical sterilization (hysterectomy, bilateral salpingectomy, 
bilateral oophorectomy, or bilateral tubal ligation at least 2 
months prior to Screening) 
• Sexual activity is limited to a male partner who has undergone 
effective surgical sterilization provided that partner is the sole 
sexual partner of the female study subject 
• Heterosexual abstinence is only considered a highly effective 
method if abstinence is defined as refraining from heterosexual 
intercourse for a period that covers the entire period of potential 
drug and drug effect exposures. As such, the effectiveness of 
sexual abstinence needs to be evaluated in relation to the 
duration of the clinical study, the duration of drug effects, and 
the preferred and usual lifestyle of the participant. In the case of 
this study, minimum time adherence prior to first dosing is 3 
months, and must continue for 3 months after dosing. 
Unacceptable Methods of Contraception 
Periodic abstinence (calendar, “symptothermal”, and post-ovulation 
methods), withdrawal (coitus interruptus), spermicides only and 
lactational amenorrhea method are not acceptable methods of 
contraception. A female condom and male condom should not be used 
together. 
Appendix 3 
85 
 
 
 
 
 
 
 
(added text) 
 
 
 


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Administrative changes: Minor changes involving grammar, abbreviations, wordsmithing, punctuation, and other editorial changes have been 
made throughout the document. “Patient” was changed to “subject” throughout the protocol as per standard study documentation. Additionally, 
study personnel were added as Medical Monitor. All changes are clearly identified in the red line (track-changes) version of the amendment. 
 
 

SAP_001.pdf: 
D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120)
Mind Medicine - Protocol MMED007
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023
Page 1 of 96
Statistical Analysis Plan (SAP)
Purpose of Analysis:
Clinical Study Report (CSR)
Investigational Product:
D-LYSERGIC ACID
DIETHYLAMIDE (LSD)
D-TARTRATE (MM-120)
Protocol Number:
MMED007
Document Status/
Version Number
Final 2.0
Date:
19DEC2023
SAP FOR CSR
Trial Statistician:
Statistical
programmer:




D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120)
Mind Medicine - Protocol MMED007
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023
 Page 3 of 96 
TABLE OF CONTENTS 
TABLE OF CONTENTS ............................................................................................... 3 
LIST OF ABBREVIATIONS AND ACRONYMS ...................................................... 8 
1 
INTRODUCTION ...................................................................... 10 
2 
TRIAL DESIGN, STUDY DOCUMENTS, DATABASE CODING
10 
2.1 
TRIAL DESIGN .............................................................................. 10 
2.1.1 
Trial design .......................................................................................10 
2.1.2 
Schedule of assessments and visit windows .....................................15 
2.1.3 
Visit windows ...................................................................................18 
2.2 
STUDY DOCUMENTS .................................................................. 22 
2.3 
STUDY DATABASES .................................................................... 22 
3 
ASSIGNMENT OF PREFERRED TERMS TO ORIGINAL 
TERMINOLOGY 22 
4 
REQUIREMENTS FOR SAP EXECUTION............................. 22 
5 
RESPONSIBILITIES ................................................................. 22 
6 
SOFTWARE FOR STATISTICAL ANALYSIS ....................... 22 
7 
OBJECTIVES ............................................................................. 22 
7.1 
PRIMARY OBJECTIVE ................................................................. 22 
7.2 
SECONDARY OBJECTIVES ........................................................ 22 
7.3 
Exploratory Objective ...................................................................... 23 
8 
VARIABLES/ENDPOINTS AND DEFINITIONS ................... 23 
8.1 
SUBJECT CHARACTERISTICS ................................................... 23 
8.1.1 
Demographic characteristics .............................................................23 
8.1.2 
Baseline disease characteristics ........................................................23 
8.2 
PHYSICAL EXAMINATION AT BASELINE .............................. 23 
8.3 
MEDICAL HISTORY AND CONCOMITANT DISEASES ......... 23 
8.3.1 
ADHD Medical history .....................................................................24 
8.4 
PREVIOUS AND CONCOMITANT MEDICATIONS ................. 24 
8.4.1 
Previous medications ........................................................................25 
8.4.2 
Concomitant medications during treatment period ...........................25 
8.4.3 
Prohibited concomitant medications. ................................................25 
8.5 
EXPOSURE TO INVESTIGATIONAL MEDICAL PRODUCT 
(IMP) 
25 
8.6 
COMPLIANCE WITH STUDY TREATMENT ............................ 25 
8.7 
TRIAL DISCONTINUATION ........................................................ 26 
8.8 
EFFICACY ENDPOINTS ............................................................... 26 
8.8.1 
Primary endpoint ...............................................................................26 
8.9 
SECONDARY ENDPOINTS .......................................................... 26 
8.9.1 
ADHD related endpoints ...................................................................26 
8.9.2 
Pharmacokinetic endpoints ...............................................................27 


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Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 4 of 96 
8.9.3 
Acute effects (Pharmacodynamic) endpoints ....................................27 
8.10 
EXPLORATORY ENDPOINTS ..................................................... 28 
8.11 
SAFETY ENDPOINTS ................................................................... 28 
8.11.1 
Adverse events (AEs) .......................................................................28 
8.11.2 
Death .................................................................................................29 
8.11.3 
Laboratory .........................................................................................29 
8.11.4 
Vital signs .........................................................................................32 
8.11.5 
Resting 12-lead ECG ........................................................................32 
8.11.6 
Physical examination ........................................................................32 
8.11.7 
Columbia-Suicide Severity Rating Scale ..........................................32 
9 
ANALYSIS SETS, GROUPS AND SUBGROUPS .................. 32 
9.1 
ANALYSIS SETS ........................................................................... 32 
9.2 
GROUPS .......................................................................................... 33 
9.3 
SUBGROUPS .................................................................................. 33 
10 
STATISTICAL ANALYSIS ...................................................... 33 
10.1 
GENERAL STATISTICAL METHODOLOGY ............................ 33 
10.2 
SUBJECT DISPOSITION, PROTOCOL VIOLATIONS AND 
TRIAL TERMINATION .............................................................................................. 33 
10.3 
SUBJECT CHARACTERISTICS ................................................... 34 
10.3.1 
Demographic characteristics .............................................................34 
10.3.2 
Baseline disease characteristics ........................................................34 
10.3.3 
Medical history and concomitant diseases ........................................34 
10.3.4 
Previous and concomitant medications .............................................34 
10.3.5 
Cognitive Performance Tests (Computer Test) ................................35 
10.4 
EXPOSURE TO STUDY TREATMENT ....................................... 35 
10.5 
COMPLIANCE WITH STUDY TREATMENT ............................ 35 
10.6 
TRIAL DISCONTINUATION ........................................................ 35 
10.7 
PRIMARY EFFICACY ENDPOINT .............................................. 35 
10.7.1 
Statistical model and hypotheses ......................................................36 
10.7.2 
Main analysis ....................................................................................36 
10.7.3 
Sensitivity analyses ...........................................................................38 
10.7.4 
Other exploratory analyses ...............................................................39 
10.8 
SECONDARY EFFICACY ENDPOINTS ..................................... 40 
10.8.1 
Key Secondary Endpoint ..................................................................40 
10.8.2 
Other Secondary Endpoints ..............................................................40 
10.9 
PHARMACOKINETICS ................................................................. 40 
10.9.1 
Pharmacokinetic Parameters .............................................................40 
10.9.2 
Handling of Below Lower Limit of Quantification (BLOQ) 
values ................................................................................................42 
10.9.3 
Summary Statistics ...........................................................................42 
10.10 
PHARMACODYNAMICS ............................................................. 43 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 5 of 96 
10.10.1 
5 Dimensions of Altered States of Consciousness scale (5D-
ASC). ................................................................................................43 
10.10.2 
Mystical Experience Questionnaire (MEQ),  drug effect Visual 
Analog Scale (VAS). ........................................................................43 
10.11 
EXPLORATORY ENDPOINTS ..................................................... 44 
10.12 
SAFETY ENDPOINTS ................................................................... 44 
10.12.1 
Adverse events ..................................................................................44 
10.12.2 
Vital signs .........................................................................................45 
10.12.3 
Resting 12-lead ECG ........................................................................46 
10.12.4 
Laboratory .........................................................................................46 
10.12.5 
Physical examination ........................................................................46 
10.12.6 
Columbia-Suicide Severity Rating Scale ..........................................46 
11 
STUDY DEFINITIONS AND CONVENTIONS ...................... 46 
11.1 
DEFINITIONS ................................................................................. 46 
11.1.1 
General definition of terms ...............................................................46 
11.2 
Derivation, algorithm and conversion rules ..................................... 47 
11.2.1 
Time since diagnosis .........................................................................47 
11.2.2 
Change from baseline .......................................................................47 
11.3 
CONVENTIONS ............................................................................. 48 
11.3.1 
Missing data ......................................................................................48 
11.3.2 
Handling of missing data ..................................................................48 
11.3.3 
Handling of missing date and time fields .........................................48 
12 
LIST OF SUMMARY TABLES, LISTINGS AND FIGURES 
(TLFs) 
50 
12.1 
Subject disposition ...................................................................... 50 
12.2 
Subject characteristics ................................................................. 50 
12.2.1 
Demographics ............................................................................. 50 
12.2.2 
Baseline disease characteristics .................................................. 50 
12.2.3 
Medical history and concomitant diseases .................................. 51 
12.2.4 
Previous and concomitant medication ........................................ 51 
12.2.5 
Cognitive Performance Tests (Computer Test) .......................... 52 
12.3 
Study treatment exposure and compliance ................................. 52 
12.3.1 
Exposure to study treatment ....................................................... 52 
12.3.2 
Compliance with study treatment ............................................... 53 
12.3.3 
Trial discontinuation ................................................................... 53 
12.4 
Primary and secondary efficacy endpoint(s) .............................. 53 
12.4.1 
Primary efficacy endpoint ........................................................... 53 
12.4.2 
Sensitivity analysis ..................................................................... 54 
12.4.3 
Other exploratory analyses ......................................................... 54 
12.4.4 
Secondary endpoint(s) ................................................................ 55 
12.5 
PHARMACOKINETICS ............................................................ 56 
12.6 
PHARMACODYNAMICS ........................................................ 56 
12.7 
Exploratory and other efficacy endpoints ................................... 57 
12.8 
Safety endpoints .......................................................................... 57 
12.8.1 
Adverse events ............................................................................ 57 
12.8.1.1. Subgroup analysis ......................................................................................... 59 
12.8.2 
Vital signs ................................................................................... 60 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 6 of 96 
12.8.3 
Resting 12-lead ECG .................................................................. 60 
12.8.4 
Columbia-Suicide Severity Rating Scale ..........................................61 
12.8.5 
Laboratory ................................................................................... 61 
12.8.6 
Physical examination .................................................................. 61 
13 
APPENDICES ............................................................................ 62 
APPENDIX A - TABLE, FIGURE AND LISTING LAYOUTS ............................... 62 
13.1 
TABLE LAYOUTS ......................................................................... 62 
13.1.1 
Layout T1 ..........................................................................................62 
13.1.2 
Layout T2 ..........................................................................................62 
13.1.3 
Layout T3 ..........................................................................................62 
13.1.4 
Layout T4 ..........................................................................................63 
13.1.5 
Layout T5 ..........................................................................................63 
13.1.6 
Layout T6 ..........................................................................................64 
13.1.7 
Layout T7 ..........................................................................................64 
13.1.8 
Layout T8 ..........................................................................................64 
13.1.9 
Layout T9 ..........................................................................................65 
13.1.10 
Layout T10 ........................................................................................65 
13.1.11 
Layout T11 ........................................................................................66 
13.1.12 
Layout T12 ........................................................................................66 
13.1.13 
Layout T13 ........................................................................................67 
13.1.14 
Layout T14 ........................................................................................67 
13.1.15 
Layout T15 ........................................................................................69 
13.1.16 
Layout T16 ........................................................................................70 
13.1.17 
Layout T17 ........................................................................................70 
13.1.18 
Layout T18 ........................................................................................71 
13.1.19 
Layout T19 ........................................................................................71 
13.1.20 
Layout T20 ........................................................................................72 
13.1.21 
Layout T21 ........................................................................................72 
13.1.22 
Layout T22 ........................................................................................73 
13.1.23 
Layout T23 ........................................................................................74 
13.1.24 
Layout T24 ........................................................................................74 
13.1.25 
Layout T25 ........................................................................................75 
13.1.26 
Layout T26 ........................................................................................75 
13.1.27 
Layout T27 ........................................................................................75 
13.1.28 
Layout T28 ........................................................................................76 
13.1.29 
Layout T29 ........................................................................................76 
13.1.30 
Layout T30 ........................................................................................77 
13.2 
LISTING LAYOUTS ...................................................................... 78 
13.2.1 
Layout L1 ..........................................................................................78 
13.2.2 
Layout L2 ..........................................................................................78 
13.2.3 
Layout L3 ..........................................................................................78 
13.2.4 
Layout L4 ..........................................................................................78 
13.2.5 
Layout L5 ..........................................................................................78 
13.2.6 
Layout L6 ..........................................................................................79 
13.2.7 
Layout L6a ........................................................................................79 
13.2.8 
Layout L7 ..........................................................................................80 
13.2.9 
Layout L8 ..........................................................................................80 
13.2.10 
Layout L9 ..........................................................................................80 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 7 of 96 
13.2.11 
Layout L10 ........................................................................................80 
13.2.12 
Layout L11 ........................................................................................81 
13.2.13 
Layout L12 ........................................................................................81 
13.2.14 
Layout L13 ........................................................................................81 
13.2.15 
Layout L14 ........................................................................................81 
13.2.16 
Layout L15 ........................................................................................82 
13.2.17 
Layout L16 ........................................................................................82 
13.2.18 
Layout L17 ........................................................................................82 
13.2.19 
Layout L18 ........................................................................................83 
13.2.20 
Layout L19 ........................................................................................85 
13.2.21 
Layout L20 ........................................................................................85 
13.2.22 
Layout L21 ........................................................................................85 
13.2.23 
Layout L22 ........................................................................................86 
13.2.24 
Layout L23 ........................................................................................86 
13.2.25 
Layout L24 ........................................................................................86 
13.2.26 
Layout L25 ........................................................................................87 
13.2.27 
Layout L26 ........................................................................................87 
13.2.28 
Layout L27 ........................................................................................87 
13.2.29 
Layout L28 ........................................................................................87 
13.3 
FIGURE LAYOUTS ....................................................................... 89 
13.3.1 
Figure F1 ...........................................................................................89 
13.3.2 
Figure F2 ...........................................................................................89 
13.3.3 
Figure F3 ...........................................................................................90 
13.3.4 
Figure F4 ...........................................................................................91 
13.3.5 
Figure F5 ...........................................................................................91 
APPENDIX B – DOCUMENT HISTORY ................................................................. 93 
APPENDIX C – PROHIBITED MEDICATIONS ...................................................... 95 
APPENDIX D – CHANGES TO THE ANALYSES PLANNED IN THE STUDY 
PROTOCOL 
96 
 
 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 8 of 96 
LIST OF ABBREVIATIONS AND ACRONYMS 
ADHD 
Attention-deficit/hyperactivity disorder 
AE 
Adverse event 
AISRS 
Adult ADHD investigator symptom rating scale 
ADHD-RS 
Attention-deficit/hyperactivity disorder-rating scale 
ALT 
Alanine aminotransferase 
AST 
Aspartate aminotransferase 
ASRS 
Adult attention-deficit/hyperactivity disorder self-reporting rating scale 
AUC 
Area under the curve concentration in plasma 
BMI 
Body mass index 
BP 
Blood pressure 
CBD 
Cannabidiol 
CAARS 
Connors’ adult ADHD rating scale 
CAARS-L-SR 
Connors’ adult ADHD rating scale self-report long form 
CAARS-S-OR 
Connors’ adult ADHD rating scale observer-rated short screening 
CKD-EPI 
Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 
equation 
CGI-S 
Clinical Global Impression - Severity of Illness Scale 
Cmax 
Maximum observed drug concentration 
COVID-19 
Coronavirus disease 2019 
CRF 
Case report form 
CSR 
Clinical study report 
C-SSRS SCN 
Columbia-suicide severity rating scale at screening 
C-SSRS-SLV 
Columbia-Suicide Severity Rating Scale-Since Last Visit 
CYP 
Cytochrome P450 
5D-ASC 
5 dimensions of altered states of consciousness scale  
DMT 
Dimethyltryptamine 
DSM-5 
Diagnostic and statistical manual version 5 
ECG 
Electrocardiogram 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
EOS 
End of Study 
EOT 
End of Treatment 
ET 
FA 
Early Termination 
Factor Analysis 
GGT 
Gamma-glutamyl transferase 
HR 
Heart rate 
IE 
Intercurrent event 
IMP 
Investigational medicinal product 
LSD 
Lysergic acid diethylamide 
MAOI 
Monoamine oxidase inhibitor 
MCH 
Mean corpuscular hemoglobin 
MCV 
Mean corpuscular volume 
MDMA 
3,4-methylenedioxymethamphetamine 
MEQ30 
Mystical experience questionnaire 30 items 
MINI 
Mini International Neuropsychiatric Interview 
Ml 
Milliliter 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 9 of 96 
MM-120 
 
PCA 
Mind Medicine, Inc. compound dose for D-lysergic acid diethylamide D-
tartrate 
Principal Component Analysis 
PGX 
Pharmacogenomics 
PK 
Pharmacokinetic 
QTcF 
QT interval corrected using Fridericia’s formula 
RR 
Respiratory rate 
SAE 
Serious adverse events 
SNDRI 
Serotonin-norepinephrine-dopamine reuptake inhibitor 
SNRI 
Selective serotonin reuptake inhibitor 
SSRI 
Selective serotonin reuptake inhibitor 
SUSAR 
Unexpected serious adverse reaction 
T1/2 
Terminal elimination half-life (h) 
TCA 
Tricyclic antidepressant 
THC 
Tetrahydrocannabidiol 
Tmax 
Time of peak plasma concentration 
ULN 
Upper limit of normal 
VAS 
Visual analog scale 
WOCBP 
Women of childbearing potential 
 
 
 
 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 10 of 96 
1 
INTRODUCTION 
This Statistical Analysis Plan (SAP) is based on the study protocol MMED007, final 
version 5.0, dated 10 February 2022.  
The purpose of this document is to provide details concerning the data analyses and 
presentation of the study data in line with the objectives of the study. All the 
definitions, derivation rules and handling of missing data procedures will be detailed 
as well as references to the variables and datasets provided; details regarding efficacy 
analysis will be given.  
Table, figure and listing layouts will also be provided in this document. 
2 
TRIAL DESIGN, STUDY DOCUMENTS, DATABASE CODING 
2.1 
TRIAL DESIGN 
2.1.1 Trial design 
This is a randomized, double-blind, placebo-controlled, Phase 2a study on the efficacy 
and safety of repeated low dose D-lysergic acid diethylamide (LSD) D-Tartrate (MM-
120) in adult subjects aged ≥ 18 and ≤ 65 with attention-deficit/hyperactivity disorder 
(ADHD).  
Eligible subjects that consent to participate will be randomized in a 1:1 allocation to 
placebo or MM-120. 
There will be 2 arms: 
● Arm 1-Placebo: a total of 26 subjects will receive a placebo identical in appearance 
to the IMP administered orally twice weekly for 6 weeks. Subjects and site staff 
will remain blinded to the treatment group. 
● Arm 2-MM-120: a total of 26 subjects will receive 20 μg of MM-120 twice weekly 
for 6 weeks. Subjects and site staff will remain blinded to the treatment group. 
Potential study subjects who provide informed consent will have eligibility 
evaluated/confirmed at 2 visits: 1) Screening, and 2) Baseline. The screening visit 
occurs up to 4 weeks prior to Baseline. An assessment will be made to confirm or 
make the ADHD diagnosis with the Mini International Neuropsychiatric Interview 
(MINI). The subject must have an Adult Attention Deficit Investigator Symptom 
Rating Scale (AISRS) score of ≥ 26 and a Clinical Global Impression - Severity of 
Illness Scale (CGI-S) score of ≥ 4 at screening and must meet all other eligibility 
criteria: 
Inclusion criteria 
1. Ability and willingness to provide written, informed consent prior to initiation 
of any study-related procedures and to adhere to all study requirements. 
NOTE: The subject (i.e., not a legally authorized representative) must be 
cognitively able to understand the requirements of the study and provide the 
informed consent. 
2. Age ≥ 18 and ≤ 65 years at Screening. 


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Mind Medicine - Protocol MMED007 
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3. Subjects with the diagnosis of Diagnostic and Statistical Manual of Mental 
Disorders-5 (DSM-5) ADHD, as determined by clinical evaluation and 
confirmed by structured interview (MINI). 
4. AISRS total score of ≥26 at screening. 
5. CGI-S score of ≥4 at screening. 
6. Must be willing to receive IMP dose twice weekly. On Day 1, the subject will 
come to the clinic and must be willing to take a taxi or public transportation 
home or be accompanied by a caregiver and not drive a car, use heavy 
equipment, or participate in any other dangerous activity for the remainder of 
the day after receiving IMP (NOTE: at any protocol visit after Day 1 dosing, 
dosing visits may occur at the subject's home at the discretion of the PI, 
conducted by one of the study investigators or delegate and administered under 
supervision followed by the performance of the same procedures done at the 
clinic including safety monitoring. If early withdrawal is considered due to 
any safety issue identified, the Sponsor's medical monitor should be notified. 
If a remote visit is conducted due to any reason related to the COVID-19 
pandemic, notification must be sent to the Medical Monitor's dedicated email 
address and Urgent Safety Measures as outlined in this protocol must be 
followed.) 
7. Must be willing to refrain from more than 6 standard alcoholic drinks per week 
(1 standard drink corresponds to 0.1 L wine, 0.3 L beer, or 4 cL liquor), more 
than 10 cigarettes a day, and more than 2 cups of coffee a day throughout the 
study treatment period (6 weeks) and until the last study visit is complete (EOS 
or ET). 
Exclusion criteria 
1. Past or present diagnosis of a primary psychotic disorder or first-degree 
relative with a psychotic disorder. 
2. Past or present bipolar disorder (DSM-5). 
3. Other current psychiatric disorders that, in the opinion of the Investigator or 
medical supervisor, may confound the results of the study (e.g., obsessive-
compulsive disorder,dysthymic disorder, panic disorder, dissociative 
disorder, anorexia nervosa or bulimia nervosa). 
4. Subjects with 
 
substance use disorder (except nicotine, provided subject does not smoke 
 
5. Somatic disorders including Central Nervous System (CNS) involvement of 
cancer, severe cardiovascular disease, untreated hypertension, severe liver 
disease (liver enzyme increase by more than 3x the upper limit of normal 
except unconjugated hyperbilirubinemia due to Gilbert's Disease, per 
Investigator), severely impaired renal function (estimated creatinine clearance 
< 50 mL/min by CKD-EPI formula), or anything else that, in the judgment of 
the Investigator or medical supervisor, poses too great a potential for side 
effects. 
6. Any lifetime history of suicide attempt; 
 
 active suicidal thoughts or ideation (defined as a suicidal 
ideation score of 2 or greater in the Columbia-Suicide Severity Rating Scale 
[C-SSRS]); or endorsement of any suicidal behavior on the C-SSRS within the 
 the screening visit. 


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7. Likely to require psychiatric hospitalization during the course of the study. 
8. Once consent is signed, subject not willing or able to stop any prescription or 
nonprescription ADHD medications during screening and prior to the baseline 
visit through final study visit (EOS or ET). A list of prohibited medications is 
provided in APPENDIX C.  
9. Plan to start, stop, or alter the use of any medications, supplements, or other 
therapeutics from Baseline until EOS or ET (see Appendix 1 for list of 
prohibited medications). 
10. Plan to start, stop or alter the use of psychotherapy, massage, meditation, 
acupuncture, hypnosis, yoga, or other similar therapy/activity from the time of 
providing informed consent until EOS or ET. 
11. 
 
 
 
 
 
 
 
 
 
 
12. Likely to need use of any psychiatric medications with the potential to 
confound interpretation of study results or impact safety, at the discretion of 
the Investigator, in the 10 weeks following Baseline up to EOS or ET (see 
APPENDIX C for list of prohibited medications). 
13. Use of investigational medication/treatment in the past 30 days prior to the 
screening visit. 
14. 
 
 
15. Clinically significant abnormal baseline laboratory values, VSs, and ECG that 
include the following: 
a. Have evidence of clinically significant hepatic disorder (e.g., alanine 
aminotransferase [ALT] or aspartate aminotransferase [AST] > 3X 
ULN (except for Gilbert’s disease), and  
b. Any clinically significant abnormal metabolic or hematologic screen, 
per Investigator or medical supervisor decision 
c. Exclusionary blood pressure: >140 mm Hg (systolic) or >90 mm Hg 
(diastolic); heart rate <45 beats/minute or >90 beats/minute after an 
approximately 5- minute supine or semi-supine rest NOTE: If the first 
measurement of a subject's heart rate is > 90 beats/minute, a second 
recording is allowed after an additional approximately 5-minute supine 
rest  
d. Exclusionary ECG parameters: QTcF > 450 msec (men), QTcF >470 
msec (women)  
e. Any clinically significant abnormal electrocardiogram (ECG) finding 
(e.g., uncontrolled atrial fibrillation, ischemia) at Screening (Visit 1) 
or Baseline (Visit 2), as determined by the Investigator or medical 
supervisor (in consultation with a cardiologist, if needed. 
16. Any other condition, therapy, laboratory abnormality, or other circumstance 
that, in the opinion of the Investigator or medical supervisor, may pose 
additional risk to the subject from participation in the study, may interfere with 
the subject’s ability to comply with study procedures, may make participation 
in the study not in the subject's best interest or may confound the results of the 
study. 
17. Prior history or ongoing neuropsychiatric signs or symptoms associated with 
COVID-19 such as development of, or current disorder, during or after a 


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COVID-19 infection including anxiety, memory loss, confusion, depression, 
delirium, agitation, or psychosis. 
18. Women of childbearing potential (WOCBP) (i.e., physiologically capable of 
becoming pregnant) who are unwilling or unable to use a highly effective 
method of contraception, (see Protocol Appendix 2) for the duration of the 
study, OR Men physiologically capable of fathering a child who are sexually 
active with WOCBP but are unwilling or unable to use barrier contraception 
(e.g., condom with or without spermicidal cream or jelly) for the duration of 
the study. NOTE: See Protocol Appendix 2 for definitions of WOCBP and 
highly effective methods of contraception and for information about 
unacceptable methods of contraception. 
19. Women who are currently pregnant or breastfeeding or plan to become 
pregnant or breastfeed during the study. 
20. Men who plan to donate sperm during the study. 
21. Use of weight loss drugs 
of screening until the end of study. 
22. Subjects who are either unable or unwilling to consume alcohol in any amount 
(including due to religious or personal reasons). 
23. Subjects who have a change in AISRS score of ≥13-points between screening 
and baseline visits. 
The baseline visit will occur on the clinic day before Day 1 and will confirm AISRS 
score. If there is a ≥ 13-point change in the AISRS between the screening visit 
assessment and the baseline assessment, or if the subject does not return for the 
baseline AISRS, the subject will not be randomized, and will be terminated from the 
study. Eligible subjects will be randomized at Day 1 to either 20 μg of MM-120 or to 
matching placebo and begin the double-blind treatment period on Day 1. 
Double-blind treatment period: 
The double-blind treatment period will last 6 weeks, with dosing twice weekly (every 
3 to 4 days). Day 1 will be the first day of dosing. At the end of the 6 weeks-treatment 
period, subjects will be assessed by a study physician. All subjects and site staff will 
remain blinded to the treatment group. 
Subjects will be provided with a diary in which the sleep quality/ duration rating data  
will be recorded. 
Follow-up: 
There will be a single follow-up visit 4 weeks after the last double-blind treatment 
visit (i.e., at Week 10). 
 
 




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2.1.2 Schedule of assessments and visit windows 
Table 1 reports full details on the schedule of assessments.  
For all measurements, the actual date and time of assessment, including date of sampling, will be recorded in the eCRF. 
Table 1: Schedule for study specific assessments. 
 
Time in Weeks 
 
Screening 
 
Baseline 
g 
 
Dosi
ng 
begi
ns 
Dosing Period (20 μg MM-120) h 
6-week Blinded Treatment 
End of Study/ 
Early 
Termination h 
Arm 1 - placebo Arm 
2 – MM-120 
Up to 4 
weeks prior 
to Day -1 
Day -1 
Day 
1 
Week 2 
(Pre-dose on 
3rd dosing 
visit) 
Day 8 (+/- 1 
day) 
Twice weekly* 
Dosing 
(+/- 1 day) 
(Starts Day 1) 
Every 2 
weeks 
(first dose 
of the 
week) 
(Starts 
Day 15) 
Week 6 
(before 
final dose 
unless 
otherwise 
noted) 
Week 10 
follow-up or 
final visit if 
withdrawing 
from study 
Informed consent 
X 
 
 
 
 
 
 
 
Demography 
X 
 
 
 
 
 
 
 
Medical/surgical 
history 
X 
 
 
 
 
 
 
 
Inclusion/exclusion 
criteria 
X 
X 
 
 
 
 
 
 
Pregnancy test (for 
women without 
documentation of 
sterilization) 
X 
 
X 
 
X8 
 
 
X 
Physical examination 
X 
 
 
 
 
 
X 
X 
Weight and BMI a 
X 
 
 
 
 
 
X 
X 
Height 
X 
 
 
 
 
 
X 
X 
Vital signs b 
X 
X 
X 
 
X 
 
X 
X 
Clinical Laboratory 
Tests c 
X 
 
 
 
 
X 
X 
X 
Pharmacokinetics 
 
 
X7 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pharmacodynamics 
(5D- ASC, & MEQ30) 
d 
 
 
X 
 
 
 
X1, 5 
 
12-lead ECG e 
X 
 
X4 
 
 
 
X4 
 
Cognitive 
Performance Test 
 
X 
 
 
 
 
X 
 
CAARS f 
X 
X 
 
 
 
X 
X 
X 


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Time in Weeks 
 
Screening 
 
Baseline 
g 
 
Dosi
ng 
begi
ns 
Dosing Period (20 μg MM-120) h 
6-week Blinded Treatment 
End of Study/ 
Early 
Termination h 
Arm 1 - placebo Arm 
2 – MM-120 
Up to 4 
weeks prior 
to Day -1 
Day -1 
Day 
1 
Week 2 
(Pre-dose on 
3rd dosing 
visit) 
Day 8 (+/- 1 
day) 
Twice weekly* 
Dosing 
(+/- 1 day) 
(Starts Day 1) 
Every 2 
weeks 
(first dose 
of the 
week) 
(Starts 
Day 15) 
Week 6 
(before 
final dose 
unless 
otherwise 
noted) 
Week 10 
follow-up or 
final visit if 
withdrawing 
from study 
ASRS (done prior to 
dosing) 
 
X 
 
 
 
X 
X 
X 
AISRS, CGI-S 
X 
X 
 
X 
 
 
X 
X 
MINI 
X 
 
 
 
 
 
 
 
C-SSRS 
screening/baseline 
X 
 
 
 
 
 
 
 
C-SSRS since last visit 
(SLV) 
 
X 
X 
 
X 
 
X 
X 
VAS 
 
 
X6 
 
 
 
 
 
Check daily diary 
X 
X 
X 
 
X 
 
X 
X 
Randomization 
 
 
X 
 
 
 
 
 
MM-120 or placebo 
administration 
 
 
X 
 
X3 
 
 
 
Adverse events 
X 
X 
X 
 
X 
 
X 
X 
Concomitant 
medication 
X 
X 
X 
 
X 
 
X 
X 
Blood sample 
collection for 
biobanking (PGX 
analysis) 
X 
If the subject gives informed consent to provide a pharmacogenomic sample, collect a sample once during the study 
 
Abbreviations: 5D-ASC = 5 dimensions of altered states of consciousness scale; AISRS = Adult ADHD Investigator Symptom Rating Scale; ASRS = Adult ADHD Self-Report Scale; BMI = body mass index; BP = blood pressure; CAARS = 
Conners’ Adult ADHD Rating Scale; CGI-S = Clinical Global Impression Scale; C-SSRS = Columbia-Suicide Severity Rating Scale; ECG = electrocardiogram; MEQ30 = Mystical Experience Questionnaire (30-item); PGX = 
pharmacogenomics; VAS = Visual Analog Scale. 
*Twice weekly dosing will occur every 3 to 4 days (e.g., every Monday and Wednesday) with a ± 1 day window and will be coordinated to occur at the same time as the Week 2 visit and the every 2 weeks visits when possible. 
a 
Body mass index will be calculated using body height at screening. 
b 
Vital signs (pulse, BP, HR, RR, and body temperature) will be performed at every visit. 
c 
Clinical laboratory samples for chemistry and hematology and urine samples for 
 and pregnancy testing will be collected pre-dose. 
d 
Pharmacodynamic scales are completed at home up to 6 hours after dosing. 
e 
Subject should be supine for 5 minutes prior to ECG collection. 
f 
CAARS-S-OR conducted at screening. All other assessments will be with the CAARS-L-SR. 


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Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 17 of 96 
g 
Baseline visit is within 3 days of Day 1 (±1 day). 
h 
Following day 1 dosing, all visits may be conducted remotely per Investigator decision as long as all activities can be conducted per protocol, e.g., calibrated blood pressure cuff, calibrated weight scale, ECG, computer 
cognitive scale. Any visit conducted remotely due to COVID-19 requires Sponsor Medical Monitor and operations team notification and conduct under urgent safety measures and all protocol deviations captured in EDC 
designated COVID-19 deviation. 
 
X1 
subject fills out forms at home. 
 
 
X3 
6 weeks of blinded treatment on MM-120 / placebo; may be dosed at home per Investigator decision. 
X4 
2 hours after dosing. 
X5 
6 hours after dosing. 
X6 
Collected repeatedly 0-6 hours after dosing. 
X7 
PK samples will be collected at pre-dose, 0.5, 1, 2, 3, 4, and 6 hours post-dose. 
X8 
During treatment period, pregnancy testing will occur predose at each dosing visit or a minimum of once weekly. All pregnancy test results are being recorded on the subject’s source document (paper record). The 
pregnancy test results are not entered into the eCRF for weeks 3, 5, and 6.   
 
 


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Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023 
 
 
 
Page 18 of 96 
 
2.1.3 Visit windows 
As subjects do not always adhere to the protocol visit schedule, the following rules will be applied 
to assign actual visits to analysis visits for all parameters.  
The visit windows and the target days for each visit (including unscheduled ones) are listed below 
in Table 2. The reference day is Day 1, the first day of dosing, as defined in Section 11.1.1. If a 
subject has two or more actual visits in the same visit window, the visit closest to the target day 
will be used for recording data from that visit in the EDC. The data collected scheduled and 
unscheduled visit(s) will be mapped  to visits as follows:  If two actual visits are equidistant from 
the target day within a visit window, the later visit will be used; if more than one value falls on 
the same day then the last sequential number in sdtm will be used.  
All assessments corresponding to both scheduled and unscheduled visits will be included in 
subject listings.  
Table 2 contains analysis visit windows and the target study days for the following selected visits: 
Baseline, Week 2, Week 4, Week 6 and Week 10; lower and upper limits associated with each 
visit will cover all possible days from randomization to end of study allowing mapping all the 
applicable assessments to the visits.  
As vital signs and Columbia-Suicide Severity Rating Scale (C-SSRS)  will be evaluated at each 
visit (twice weekly), a different time windowing will be applied to those variables only (see Table 
3). Daily diary contains daily sleep quality/ duration rating assessments that will be computed at 
each week by the mean of values recorded between lower and upper limits (days) specified in 
Table 4, no target study day will be considered. 
For parameters, where Time Interval Upper Limit for Baseline is equal to 1, please apply a rule 
of time defined in section 11.1.1.8 for Baseline. 
 
 


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Table 2: Scheduled Visit Window and Mapping of Assessments 
Assessment 
Scheduled 
Visit Number 
Scheduled 
Time point 
Label on 
output 
Targe
t 
Study 
Day* 
Time 
Interval 
Lower 
Limit 
(Day*) 
Time 
Interval 
Upper 
Limit 
(Day*) 
  
laboratory 
Baseline 
Baseline - Week 
1D1 
Baseline 
1 
No Lower 
limit 
1 
Week 2 
Week 1D5- 
Week 3D19 
Week 2 
15 
2 
21 
Week 4 
Week 4 D22- 
Week 5 D33 
Week 4 
29 
22 
35 
Week 6 
Week 6 D36 - 
Week 6 D40 
Week 6 
43 
36 
EOT 
Week 10 
Follow-up/ 
Final visit for 
withdrawals 
Week 10 
Follow-up/ 
Final visit for 
withdrawals 
Week 10 
Follow-up/ Final 
visit for 
withdrawals 
70 
EOT+1 
No Upper 
limit 
Physical 
examination,  ECG 
Baseline 
Baseline - Week 
1D1 
Baseline 
1 
No Lower 
limit 
1 
Week 6 
Week 6 D36 - 
Week 6 D40 
Week 6 
43 
2 
EOT 
Week 10 
Follow-up/ 
Final visit for 
withdrawals 
Week 10 
Follow-up/ 
Final visit for 
withdrawals 
Week 10 
Follow-up/ Final 
visit for 
withdrawals 
70 
EOT+1 
No Upper 
limit 
Pregnancy test 
Baseline 
Baseline - Week 
1D1 
Baseline 
1 
-24 
1 
Week 2 
Week 1D5- 
Week 3D19 
Week 2 
15 
2 
21 
Week 4 
Week 4 D22- 
Week 5 D33 
Week 4 
29 
22 
EOT 
Week 10 
Follow-up/ 
Final visit for 
withdrawals 
Week 10 
Follow-up/ 
Final visit for 
withdrawals 
Week 10 
Follow-up/ Final 
visit for 
withdrawals 
70 
EOT+1 
No Upper 
limit 
Questionaries 
ASRS, CAARS-L-SR 
Baseline 
Baseline -  
Week 1D1 
Baseline 
-1 
No Lower 
limit 
-1 
Week 2 
Week 1D5- 
Week 3D19 
Week 2 
15 
2 
21 
Week 4 
Week 4 D22- 
Week 5 D33 
Week 4 
29 
22 
34 


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Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 20 of 96 
Week 6 
Week 6 D36 
Week 6 D36 
36 
35 
38 
Week 6 
Week 6 D40 
Week 6 D40 
40 
39 
EOT 
Week 10 
Follow-up/ 
Final visit for 
withdrawals 
Week 10 
Follow-up/Final 
visit for 
withdrawals 
Week 10 
Follow-up/ Final 
visit for 
withdrawals 
70 
EOT+1 
No upper 
limit 
AISRS, CGI 
Baseline 
Baseline 
Baseline 
1 
No Lower 
limit 
1 
Week 2 
Week 2 D8 
Week 2 
8 
2 
21 
Week 6 
Week 6 D40 
Week 6 
40 
35 
EOT 
Week 10 
Follow-up/ 
Final visit for 
withdrawals 
Week 10 
Follow-up/Final 
visit for 
withdrawals 
Week 10 
Follow-up/ Final 
visit for 
withdrawals 
70 
EOT+1 
No upper 
limit 
Pharmacodynamics: 
5D-ASC**, MEQ-
30**, VAS**# 
Week 1 D1 
Week 1 D1 
Week 1 D1 
1 
NA 
5 
Week 6 
Week 6 D40 
Week 6 
40 
NA 
No upper 
limit 
* Relative to Study Day 1 
**No baseline assessment, post-dose at Week 1 D1 
#No assessment at Week 6, only at visit Week1 D1 post-dose 
Table 3: Scheduled Visit Window and Mapping of Assessments for Vital Sign, C-SSRS   
Scheduled Visit Number 
Scheduled 
Time point 
Label on output 
Target 
Study 
Day* 
Time 
Interval 
Lower Limit 
(Day*) 
Time Interval 
Upper Limit 
(Day*) 
Baseline 
Baseline 
Baseline - Week 
1 D1 
1 
No Lower 
limit 
1 
Week 1 D5 
Week 1 D5 
Week 1 D5 
5 
2 
6 
Week 2 D8 
Week 2 D8 
Week 2 D8 
8 
7 
10 
Week 2 D12 
Week 2 D12 
Week 2 D12 
12 
11 
13 
Week 3 D15 
Week 3 D15 
Week 3 D15 
15 
14 
17 


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Scheduled Visit Number 
Scheduled 
Time point 
Label on output 
Target 
Study 
Day* 
Time 
Interval 
Lower Limit 
(Day*) 
Time Interval 
Upper Limit 
(Day*) 
Week 3 D19 
Week 3 D19 
Week 3 D19 
19 
18 
20 
Week 4 D22 
Week 4 D22 
Week 4 D22 
22 
21 
24 
Week 4 D26 
Week 4 D26 
Week 4 D26 
26 
25 
27 
Week 5 D29 
Week 5 D29 
 
Week 5 D29 
29 
28 
31 
Week 5 D33 
Week 5 D33 
Week 5 D33 
33 
32 
34 
Week 6 D36 
Week 6 D36 
Week 6 D36 
36 
35 
38 
Week 6 D40 
Week 6 D40 
Week 6 D40 
40 
39 
EOT 
Week 10 Follow-up/Final 
visit for withdrawals 
Week 10 
Follow-up/Final 
visit for 
withdrawals 
Week 10 Follow-
up/ Final visit for 
withdrawals 
70 
EOT+1 
No upper limit 
*Relative to Study Day 1 
 
Table 4: Scheduled Visit Window and Mapping of Assessments for daily diary (Sleep Quality) 
Scheduled Visit Number 
Scheduled 
Time point 
Label on output 
Target 
Study 
Day* 
Time 
Interval 
Lower Limit 
(Day*) 
Time Interval 
Upper Limit 
(Day*) 
Baseline 
Baseline  
Baseline 
NA 
No Lower 
limit 
-1 
Week 1  
Day 1- Week 1 
D5 
Week 1  
NA 
1 
6 
Week 2  
Week 2 D8- 
Week 2 D12 
Week 2  
NA 
7 
13 
Week 3  
Week 3 D15- 
Week 3 D19 
Week 3  
NA 
14 
20 
Week 4  
Week 4 D22- 
Week 4 D26 
Week 4  
NA 
21 
27 
Week 5  
Week 5 D29- 
Week 5 D33 
Week 5  
NA 
28 
34 
Week 6  
Week 6 D36- 
Week 6 D40 
Week 6  
NA 
35 
EOT 
Week 10 Follow-up/Final 
visit for withdrawals 
Week 10 
Follow-up/Final 
visit for 
withdrawals 
Week 10 Follow-
up/ Final visit for 
withdrawals 
NA 
EOT+1 
No upper limit 
*Relative to Study Day 1; NA=Not Applicable 
 
 


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Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 22 of 96 
2.2 
STUDY DOCUMENTS 
The following study documents are used for the preparation of the SAP: 
 MMED-007 Protocol, final version 5.0, 10 February, 2022; 
 Annotated Case Report Form (CRF), version 5.0, 15 August, 2022 (MMED007 DMOP 
Attachment B Annotated CRF v5.0). 
2.3 
STUDY DATABASES 
The following study databases are used in the study: 
 
CRF database is used in the study; 
 
Randomization list. 
 
Final list with concomitant medications, including flags for intake or change in prohibited 
medications/therapies which have potential confounding effects. 
3 
ASSIGNMENT OF PREFERRED TERMS TO ORIGINAL TERMINOLOGY 
The original terms used by investigators to describe medical history and concomitant diseases, 
physical examination abnormalities, adverse events (AEs), indications for previous/concomitant 
medications will be associated with preferred terms for classification and tabulation. 
The latest MedDRA dictionary will be used for assigning preferred terms. Previous and 
concomitant therapy will be coded according to ATC. 
4 
REQUIREMENTS FOR SAP EXECUTION 
The SAP is executed after: 
1. The investigator CRF database is locked; 
2. Subject visits are completed and clean; 
3. The protocol violation database is locked; 
4. The coding database is completed and signed off. 
5 
RESPONSIBILITIES 
The Project Statistician will be responsible for selection of the statistical methods. The Statistical 
Programmer will perform the statistical programming (selected listings, summary tables, analysis 
tables, figures, and exploratory investigations, as appropriate). 
6 
SOFTWARE FOR STATISTICAL ANALYSIS 
The statistical analysis will be carried out by using SAS® version 9.4 – 
 
 
7 
OBJECTIVES 
7.1 
PRIMARY OBJECTIVE 
To assess the treatment efficacy vs placebo of repeated low doses (20 μg) of MM-120 for six weeks 
in adult subjects with ADHD measured by Adult Attention Deficit Investigator Symptom Rating 
Scale (AISRS). 
7.2 
SECONDARY OBJECTIVES 
 To assess treatment efficacy vs placebo measured by change from baseline in AISRS after 1 
week (2 doses) of treatment. 


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 To assess treatment efficacy vs placebo based on the proportion of subjects who experience at 
least a 1-point decrease in the Clinical Global Impression - Severity of Illness Scale (CGI-S). 
 To assess treatment efficacy vs placebo measured by change from baseline in CGI-S. 
 To assess other efficacy endpoints by the Adult ADHD Self-Report Scale (ASRS) and Connors’ 
Adult ADHD Rating Scale 
 To assess the pharmacokinetic (PK) profile of MM-120 in subjects with ADHD. 
 To explore the pharmacokinetic/pharmacodynamic (PK/PD) relationship of single doses of 
MM-120 and psychological and physiological effects. 
 To assess the safety and tolerability by AE and SAE assessment. 
7.3 
Exploratory Objective 
To explore sleep quality/ duration as recorded in the daily diary.  
For the purpose of future exploratory analysis (not covered in this SAP), for subjects who consent 
to provide a pharmacogenomics (PGX) sample, a single blood sample (2.5 mL) in a proprietary 
integrated standardized system for collection and stabilization of specimens (bio banking) will 
be collected during the study and stored. 
8 
VARIABLES/ENDPOINTS AND DEFINITIONS 
8.1 
SUBJECT CHARACTERISTICS 
8.1.1 Demographic characteristics 
Demographic characteristics of the subjects include age at acreening, sex at birth (male  | female) 
at screening, profession, highest education level (less than primary, primary, secondary, tertiary 
[bachelor, master, doctoral degree]) and country. Demographics data are derived from 
“Demographic Characteristics” CRF section. 
 
8.1.2 Baseline disease characteristics 
Baseline disease characteristics of the subjects include baseline values for the Adult Attention 
Deficit Investigator Symptom Rating Scale (AISRS), Clinical Global Impression - Severity of 
Illness Scale (CGI-S), Adult ADHD Self-Report Scale (ASRS) and Connors’ adult ADHD rating 
scale self-report long form (CAARS-L-SR).  
These data are reported on the “AISRS”, “CGI-S” and  “Subject Reported Outcomes” CRF 
sections. 
Baseline definition is available in section 11.1.1.  
8.2 
PHYSICAL EXAMINATION AT BASELINE 
Physical examination at Baseline includes height (cm), weight (kg), body mass index (BMI, 
kg/m2), blood pressure (mmHg), heart rate (bpm) and an assessment of the following: general 
appearance, skin, head and neck, lymph nodes, thyroid, abdomen, musculoskeletal, cardiovascular, 
respiratory, and neurological systems. 
8.3 
MEDICAL HISTORY AND CONCOMITANT DISEASES 
Medical history and concomitant diseases are collected in the “Prior Medical and Psychiatric 
Events” CRF section. 
Subject medical history pertains to any previous Disease/Disorder/Surgery/Procedure (i.e. 
conditions in the form with the box ‘ongoing’ not ticked); concomitant diseases are any of the 
above condition with the box ‘ongoing’ ticked. 


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The original terms used by the investigators to describe Disease/ Disorder/ Surgery/ Procedure will 
be coded with the MedDRA v25.1.  
Previous conditions will be reported separately from concomitant diseases.  
8.3.1 ADHD Medical history 
Attention-deficit/hyperactivity disorder (ADHD) medical history is available in the “ADHD 
Medical History” CRF section and the following characteristics are of interest:  
- Time since ADHD diagnosis (in accordance with the rules, described in Section 11.2); 
- Structured interview to assess diagnostic criteria according to DSMV [All criteria met (all 
criteria must be met for a diagnosis of ADHD in adults) | Not all criteria met]; 
- Complete CAARS-S-OR observer rating screening [(Yes|No). If Yes, then show: (A, B, C, 
D) scores]; 
- Current somatic disorder(s) [(Yes|No). If Yes, disease/disorder will be specified under 
specific SOC/PT of AEs summary; 
- 
Previous hospitalisation(s), previous disorders, (somatic and psychiatric), previous 
surgery(s) [(Yes|No). If Yes, If Yes, disease/disorder will be specified under specific SOC 
of Medical History summary; 
- Family History (psychiatric and somatic) [Yes|No]; 
- ADHD medication (prescription or non-prescription) [(Yes|No). If Yes, then show in 
separate summary table: (Name of medication/therapy, Indication, Total daily dose, Unit, 
Amount taken in the morning, Amount taken in the afternoon, Amount taken in the night 
time, Date of last dose)]; 
- Alcohol, caffeine, nicotine:  
 Current smoker [(Yes|No). If Yes, then show: (Cigarettes per day, Packs per year)]; 
 Coffee [(Yes|No). If Yes, then show: (Coffee per day)]; 
 Alcohol (Beer, wine, liquor etc. (standard drink)) [(Yes|No). If Yes, then show: (Per 
week)]; 
- MDMA/Ecstasy [(Yes|No). If Yes, then show: (Total lifetime use, Last use 
(dd.mm.yyyy))]; 
- Sedative, Narcotic (Benzos, Ketamine, Laughing gas (nitrous oxide)) [(Yes|No). If Yes, 
then show: (Total lifetime use, Last use (dd.mm.yyyy))]; 
- Hallucinogenic (LSD, Mescaline, Psilocybin) [(Yes|No). If Yes, then show: (Total lifetime 
use, Last use (dd.mm.yyyy))]; 
- Stimulants (Amphetamine, Cocaine, Methylphenidate (recreationally)) [(Yes|No). If Yes, 
then show: (Total lifetime use, Last use (dd.mm.yyyy))]; 
- Opioids (Morphine, Diacetylmorphin, Codeine, Methadone) [(Yes|No). If Yes, then show: 
(Total lifetime use, Last use (dd.mm.yyyy))]; 
- Cannabis, Marijuana, CBD [(Yes|No). If Yes, then show: (Total lifetime use, Last use 
(dd.mm.yyyy))]; 
- Others: (GHB, PCP, DXM, Spice) [(Yes|No). If Yes, then show: (Total lifetime use, Last 
use (dd.mm.yyyy))]; 
8.4 
PREVIOUS AND CONCOMITANT MEDICATIONS 
Previous and concomitant medications are collected in the "Concomitant Medications" CRF 
section. Medications for ADHD are those medications with the response “Yes” to the question 'Is 
this medication for ADHD?'. 
Missing/Partial dates will be imputed according Section 11.3.3. 


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Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 25 of 96 
8.4.1 Previous medications 
Any treatment with the stop date before the study treatment start date (see definition in 
Section 11.1.1). 
8.4.2 Concomitant medications during treatment period 
Any treatment taken during the treatment period (Section 11.1.1). This includes any treatment with: 
 The start date on or after the treatment start date and before study treatment end date 
(included) 
OR 
 The start date before the treatment start date AND the stop date after or on the study 
treatment start date 
Handling of missing dates is defined in section 11.3.3.  
8.4.3 Prohibited concomitant medications. 
Any treatment that may interfere with the IMP taken during the study. This includes treatment 
from Day -1/Baseline (Visit 2) until End of Study or Early Termination (except if needed for care 
and treatment of the subject during the study per Investigator discretion). 
The Error! Reference source not found. in APPENDIX C provides a listing of prohibited m
edications; however, it is not a comprehensive list of all restricted medications, supplements, and 
other therapeutics. Final list with prohibited medications will be identified on a case-by-case basis 
by a Sponsor medical review of the concomitant medications. 
8.5 
EXPOSURE TO INVESTIGATIONAL MEDICAL PRODUCT (IMP) 
Exposure information will be expressed in terms of treatment duration (days) derived as the 
number of days from the date of first dose of randomized treatment received (Study treatment start 
date) to the date of the last dose received (Study treatment end date), inclusive (section 11.1.1) 
according to the formula:  
 
Study treatment end date - Study treatment start date +1. 
8.6 
COMPLIANCE WITH STUDY TREATMENT 
The IMP will be administered at the clinic under supervision of study personnel (i.e., the 
Investigator or delegate) and cannot be provided to the subjects to take home. 
Compliance with treatment (%) will be always 100% if treatment is administered at each visit (12 
in total), from Week 1 D1 to Week 6 D40. 
Study treatment is considered administered if answered 'Yes' to the question "LSD / Placebo 
administered?" in the "Study Drug Administration" CRF section. Study drug administritation will 
be collected at each visit. 
If Compliance with treatment (%) is different from 100%, it will be derived according to the 
following formula: 
Total compliance (%) = (Total number of doses taken / Total number of expected doses) x 100*, 
where:  
Total number of doses taken = Total number of expected doses – Total number of missed doses. 
Total number of expected doses = 12 (number of doses to be administered at all 12 visits). 
Total number of  missed doses = number of doses not administered (study treatment is considered 
NOT administered if answered 'No' to the question "LSD / Placebo administered?" in the "Study 
Drug Administration" CRF section). 


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Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 26 of 96 
In case of “Special Situation” at any visit (answer to "Were there any special situation with the 
study drug?" is [Yes]), the compliance will be not calcultated, and the following information will 
be provided:  
• 
Number of subjects with at least one Special Situation; 
• 
Number of Special Situations; 
and number of patients with ticked box 'Yes' to any of the following: 
• 
Medication error or incorrect drug administration; 
• 
Overdose (exceeds the protocol-specified maximum); 
• 
Deliberate abuse; 
• 
Deliberate misuse; 
• 
Drug interaction; 
• 
Occupational exposure. 
8.7 
TRIAL DISCONTINUATION 
Subjects with premature trial termination are identified as those with answer 'No' to the question 
'Did the subject complete the study?' in the “Termination Form”  CRF section.  
The reasons that can be associated with the trial discontinuation are:  
• 
Lost to follow-up;  
• 
Death;  
• 
COVID-19 related;  
• 
Other (to be specified). 
8.8 
EFFICACY ENDPOINTS 
8.8.1 Primary endpoint 
The primary endpoint is the mean change from baseline in ADHD symptoms, based on the 
evaluation of the AISRS change from baseline to Week 6. 
The AISRS total score consists of 18 items from the original ADHD-RS, which were derived 
based on DSM-5 criteria for ADHD. The ADHD-RS includes 9 items that address symptoms of 
inattention and 9 items that address symptoms of impulsivity and hyperactivity. Each 
item will be rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score 
corresponds to a worse severity of ADHD. 
8.9 
SECONDARY ENDPOINTS 
8.9.1 ADHD related endpoints 
● Key secondary endpoint: change in AISRS from baseline to 1 week (Week 2, pre-dose, as 
per Schedule of assessments 2.1.2) after 2 doses of treatment; 
● Occurrence of subjects who experience at least a 1-point decrease in the CGI-S (improvement). 
The change in CGI-S from baseline to Week 2 and Week 6 will be categorized as improved 
or worsened/ no change and will be evaluated as dichotomous variable: 
𝐶𝐺𝐼−𝑆= {
𝐼𝑚𝑝𝑟𝑜𝑣𝑒𝑑 𝑖𝑓 (𝐷𝑖𝑓𝑓𝑒𝑟𝑒𝑛𝑐𝑒 𝑏𝑒𝑡𝑤𝑒𝑒𝑛 𝑤𝑒𝑒𝑘 2/6 𝑎𝑛𝑑 𝑏𝑎𝑠𝑒𝑙𝑖𝑛𝑒) < 0
𝑁𝑜 𝑐ℎ𝑎𝑛𝑔𝑒 𝑜𝑟 𝑊𝑜𝑟𝑠𝑒𝑛𝑒𝑑 𝑖𝑓 (𝐷𝑖𝑓𝑓𝑒𝑟𝑒𝑛𝑐𝑒 𝑏𝑒𝑡𝑤𝑒𝑒𝑛 𝑤𝑒𝑒𝑘 2/6 𝑎𝑛𝑑 𝑏𝑎𝑠𝑒𝑙𝑖𝑛𝑒) ≥0 


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● Change from baseline in CGI-S after 1 week (Week 2-predose) and 6 weeks (Week 6) of 
treatment; 
 
● Change from baseline to each timepoint (see Section 10.8.2.2) in subject self-assessment by the 
Adult ADHD Self-Report Scale (ASRS) and Connors’ Adult ADHD Rating Scale (CAARS-
L-SR). 
The CAARS-L-SR is a 66-item measure of ADHD symptoms. Responses are scored on a 4-
point scale, where 0 = not at all, 1 = just a little, 2 = pretty much, and 3 = very much. Item 
scores are summed to three main scores which are then transformed using population-derived 
age- and sex-adjusted norm values to a T-score. A T- score < 60 indicates no ADHD. A T-
score of 60-64 indicates borderline ADHD. A T-score of > 64 indicates ADHD. 
 
The ASRS has 18 questions, which address ADHD symptoms in adults. It uses a scale that 
ranges from 0-4 based on the individuals mark in either "never, rarely, sometimes, often, very 
often" column for a possible total score of 72. Each column is used to describe the severity 
of the individual’s symptoms based on the question asked. If four or more answers are scored 
“positive” then a high consistency of ADHD will be indicated and further follow-up with a 
licensed clinician is necessary.  
These data are derived from “AISRS”, “CGI-S” and “Subject Reported Outcomes” CRF sections 
(see Section 2.1.2 for time points). 
8.9.2 Pharmacokinetic endpoints 
PK samples will be collected at pre-dose, hours 0.5, 1, 2, 3, 4, and 6 post-dose (at “Week 1 D1”, 
first drug administration visit). The actual date and time of collection of each sample is recorded 
on the “Pharmacokinetics” CRF section. 
● Cmax, Maximum observed drug concentration 
● tmax, Time to reach Cmax 
● AUC0−t, Area under the concentration-time  curve from time zero to the measurable 
concentration time t 
● t1/2, Terminal elimination half-life 
AUC will be calculated using trapezoidal rule. Missing values will be imputed with linear 
interpolation of the non-missing values that precede and follow the missing one(s). For details of 
PK endpoints definition and analysis, refer to Section 10.9. 
8.9.3 Acute effects (Pharmacodynamic) endpoints 
● 5 Dimensions of Altered States of Consciousness scale (5D-ASC). The 5D-ASC scale is a 
visual analog scale consisting of 94 items. The instrument is constructed of five scales, and 
allows assessing mood, anxiety, derealization, depersonalization, changes in perception, 
auditory alterations, and reduced vigilance. Each item of the scale is scored on a 0-100 mm 
VAS; 
● Mystical Experience Questionnaire (MEQ), drug effect Visual Analog Scale (VAS). 
The MEQ is a 30-item questionnaire rated on a six-point scale. Data on each domain scale is 
expressed as a percentage of the maximum possible score. 
A series of single item VAS is used: “any drug effect”, “good drug effect”, bad drug effect”, 
“drug liking”, “fear”, nausea”, “alteration of vision”, “alteration of sense of time”, and “the 
boundaries between myself and my surroundings seem to blur”. 


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These data are derived from “5D-ASC”, “MEQ-30” and “VAS” CRF sections (see Section 2.1.2 
for time points). 
8.10 EXPLORATORY ENDPOINTS 
Sleep quality/duration rating evaluated based on daily diary entries (“Sleep Quality” CRF section) 
and assessment is specified in Section 2.1.1. 
The respondent marks, an integer score from 0 to 10, are defined according to the following five 
categories:  
0 = terrible,  
1–3 = poor,  
4–6 = fair,  
7–9 = good,  
10 = excellent 
8.11 SAFETY ENDPOINTS 
The evaluation of safety of study drug will be done considering the following variables:  
 Adverse events ('Adverse Event' CRF section); 
 Safety laboratory evaluation and Urine pregnancy testing ('Blood sample' and '
 
sections of the CRF); 
 Vital signs, i.e. supine blood pressure, body temperature, heart rate, respiratory rate ('Vital 
signs' CRF section); 
 12-lead safety ECG ('12-Lead ECG' CRF section); 
 Columbia-Suicide Severity Rating Scale (C-SSRS, 'C-SSRS SLV' CRF section). 
8.11.1 Adverse events (AEs) 
Adverse events (AEs) data are collected in the "Adverse Events” CRF sub-section of the “Medical 
Events” section. An Adverse Event is any untoward medical occurrence in a clinical trial which 
does not necessarily have a causal relationship with this treatment. 
As a general rule, the variable of interest will be the occurrence of at least one AE. 
8.11.1.1 Treatment-emergent adverse events (TEAEs) 
Treatment-emergent adverse events are any event with onset date/time between the study treatment 
start date and the study treatment end date, limits included. 
8.11.1.2 Intensity of the adverse events 
The intensity of an AE can be Mild (tolerable), Moderate (interferes with daily activates), Severe 
(daily activities impossible). If intensity is missing, it will be considered Severe for the analysis. 
8.11.1.3 Adverse event leading to premature treatment discontinuation 
An adverse event that led to the permanent discontinuation of study treatment is an AE with the 
'Action taken with study drug' marked as 'Drug discontinued' in the CRF section “Adverse Event”. 
8.11.1.4 AEs related to study drug 
An AE is considered related to study drug if the tick box “Relationship to the study drug” is marked 
as “Definitely Related” or “Probably Related” or “Possibly Related” in the “Adverse Event” CRF 
section. 


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8.11.1.5 Unexpected Adverse Reaction (UAR) 
When the outcome of an adverse reaction is not consistent with the applicable product information, 
this adverse reaction should be considered as an Unexpected Adverse Reaction (UAR). Information 
on UAR will not be included in the CRF but the sponsor will provide expectancy/unexpectancy 
details. 
8.11.1.6 Suspected Unexpected Serious Adverse Reaction (SUSAR) 
Suspected Unexpected Serious Adverse Reaction (SUSAR) is any suspected adverse reaction 
related to an IMP that is both unexpected and serious (expectancy/unexpectancy details will be 
provided by the Sponsor). 
8.11.1.7 Serious Adverse Event (SAE) 
An AE is considered serious if the question 'Is the event serious?' in the  
CRF section “Adverse Event” is marked as 'Yes'. 
8.11.1.8 Serious Adverse Reaction (SAR) 
A Serious Adverse Reaction (SAR) is a SAE that is determined to be related to the study treatment. 
That is, SAEs that are determined to have a causal relationship of “Possibly Related”, “Probably 
Related” or “Definitely Related” on the 'Relationship to study drug' category of the 'Adverse 
Events' CRF secion will be considered SARs. 
8.11.2 Death 
The date and the cause of death occurred during the study are derived from “Adverse Event" 
section of the CRF.  
8.11.3 Laboratory 
A routine laboratory blood test will be performed at the screening examination, and similarly 
during follow-up visits: Week 2, Week 4, Week 6 and Week 10 (see Section 2.1.2).  
In particular, the laboratory parameters are the ones listed below: 
8.11.3.1 Hematology 
 
Hemoglobin; 
 
Hematocrit; 
• MCV; 
• MCH; 
 
Platelet count; 
 
Red blood cell count; 
 
White blood cell count (including Basophils, Eosinophils, Lymphocytes, Monocytes, 
Neutrophils). 
8.11.3.2 Chemistry 
 
Albumin; 
 
Total protein; 
 
Alkaline phosphatase; 
 
ALT; 
 
AST; 
 
Bilirubin, total; 
 
Chloride; 






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8.11.4 Vital signs 
Vital signs (supine blood pressure (mmHg), body temperature (°C), respiratory rate 
(breath/minute), heart rate (bpm)) will be measured at each visit (Section 2.1.2) and collected in 
the "Vital Signs" section of the CRF. 
Refer to section 11.1.1.8 for definition of the Baseline. In case of missing time of the Vital Signs 
assessment on the date of fisrt dosing, please imput time 00:00 on the corresponding date.  
8.11.5 Resting 12-lead ECG 
A 12-lead ECG will be obtained after the subject has been resting in the supine position for at 
least 5 minutes, at time points outlined in the Section 2.1.2 (Baseline, Week 6). All ECGs will be 
documented by recording date, time of collection, all abnormal wave form noted, ventricular rate, 
all intervals including PR, RR, QRS, QT and QTcF ( “12-Lead ECG” CRF section). ECG 
abnormalities are signed as 'Yes' on 'Clinically significant findings' field of the “12-Lead ECG” 
section. 
8.11.6 Physical examination 
A physical examination will be performed at Screening, Week 6 and Week 10 and collected in 
“Physical Examination” CRF section. Physical examination includes body weight, height, BMI, 
vital signs and an assessment of the following: general appearance, skin, head and neck, lymph 
nodes, thyroid, abdomen, musculoskeletal, cardiovascular, respiratory, and neurological systems. 
8.11.7 Columbia-Suicide Severity Rating Scale 
Columbia-Suicide Severity Rating Scale is collected at Screening (C-SSRS SCN CRF page) at 
Baseline, Week 2 D8, Week 2 D12, Week 3 D15, Week 3 D19, Week 4 D22, Week 4 D26, Week 
5 D29, Week 5 D33, Week 6 D36, Week 6 D40, Week 10 Follow-up/Final visit for withdrawals 
(C-SSRS-SLV CRF page). 
9 
ANALYSIS SETS, GROUPS AND SUBGROUPS   
9.1 
ANALYSIS SETS 
Different analysis sets will be planned for the analyses and all will be identified and finalized 
before the database is locked. Subjects without valid written study informed consent will be 
excluded from all analysis sets. 
The following analysis sets are defined for the statistical analysis: 
● Screened set (SCR) - All subjects with signed written informed consent and a subject 
identification number; 
● Randomized set (RAN) – All subjects who received a randomization number, regardless of 
receiving trial medication; 
● Safety set (SAF) – All subjects who received the double-blind study drug. Subjects will be 
analyzed according to treatment received; 
● Full Analysis set (FAS) – All subjects in RAN who were not mis-randomized (Mis-
randomized subjects are those who have not been qualified for randomization or who have 
been inadvertently randomized into the study but have not received double-blind study drug). 
Following the intent-to-treat (ITT) principle, subjects will be analyzed according to the 
treatment they have been assigned to at the randomization; 
● Per Protocol set (PPS) – All subjects in FAS who took the study medication and had no 
major protocol deviations; 
● Pharmacokinetic Analysis set (PKS) – The PKS  will include all subjects who receive a 


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dose of MM-120 and have at least 1 post-dose PK measurement without major protocol 
deviations or violations thought to significantly affect the PK of the drug. Data from subjects 
with deviations determined to affect PK will be excluded from the PKS. Subjects that receive 
placebo will not be part of the PK analysis set. Subjects will be analyzed according to the 
treatment they actually received. 
9.2 
GROUPS 
Two randomized treatment groups will be used in all statistical analyses defined in this SAP (unless 
explicitly specified): 
● MM-120 (D-lysergic acid diethylamide D-tartrate (LSD); refer to definition of the Arm 2-
MM-120 in Section 2.1.1 ); 
● Placebo (refer to definition of the Arm 1-Placebo in Section 2.1.1) 
9.3 
SUBGROUPS 
Primary endpoint main analysis will be performed on the following subgroup populations: 
1. Severe ADHD: Adult Attention Deficit Investigator Symptom Rating Scale (AISRS) score of ≥ 38  
at baseline. 
2.  Moderate ADHD: Adult Attention Deficit Investigator Symptom Rating Scale (AISRS) score of < 
38 at baseline. 
10 STATISTICAL ANALYSIS 
10.1 GENERAL STATISTICAL METHODOLOGY 
Unless otherwise specified: 
 Parameters will be shown in tables and listings according to the CRF order; 
 In summary tables, all subjects will be grouped by treatment group; the 'LSD' treatment 
group will be displayed in the first column and 'Placebo' in the second; a ‘total’ column 
(including the two treatment groups) may be added in some tables as specified in TLF 
layouts section;  
 Continuous numerical variables will be summarized using the following descriptive 
statistics: n, mean, standard deviation (SD), median, Q1 (25th percentile), Q3 (75th 
percentile), minimum, and maximum; 
 Categorical including ordinal variables will be summarized by frequency and incidence; 
 All statistical tests (unless explicitly specified) will be carried out at a significant level ( 
level) of 0.05, two-tailed 95% Confidence Interval (CI) will be reported. 
 Listings include data from scheduled and unscheduled assessments; 
 
All listing will be ordered by Treatment, Subject ID, visit/date/time (where applicable). 
10.2 SUBJECT DISPOSITION, PROTOCOL VIOLATIONS AND TRIAL 
TERMINATION 
 Counts and percentages of subjects included and excluded from each analysis set will be 
provided. 


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 A summary of the subject disposition will be provided including the following variables, 
for the SCR: 
 
Subjects screened; 
 
Screen failures (screened, but not randomized); 
 
Subjects randomized; 
 
Subjects treated (who received at least one dose); 
 
Subjects who prematurely discontinued the study and reasons; 
 
Subjects who completed the study. 
A listing of subjects' disposition will be provided, based on SCR set. 
 Violations leading to exclusion from the PPS and PKS analysis sets will be listed. 
10.3 SUBJECT CHARACTERISTICS 
10.3.1 Demographic characteristics 
Summary statistics (see Section 10.1) will be summarized by treatment group and overall for all 
the  demographics characteristics (see Section 8.1.1); these summaries will be performed on the 
FAS. 
Demographics will be listed on FAS. 
10.3.2 Baseline disease characteristics 
Baseline disease characteristics (Section 8.1.2) will be summarized by treatment group and overall, 
on the FAS, using descriptive statistics for continuous and categorical data.  
10.3.3 Medical history and concomitant diseases 
Medical history and concomitant diseases (section 8.3) will be summarized separately, displaying 
counts and percentages of subjects having experienced at least one prior or concomitant disease.  
Counts and percentages of subjects having experienced at least one prior or concomitant disease 
will be presented by system organ class (SOC) and individual preferred term within each SOC as 
well as by individual preferred term. The summary tables will be presented in descending order 
according to their incidence in the active treatment group (e.g., SOC and individual preferred term 
within each SOC with the highest number of occurrences appear first); ties will be sorted 
alphabetically. 
 
The counting of the diseases is handled as follows: 
 Subjects with two occurrences of the same disease (as qualified by its preferred term(s)) 
will be counted only once; 
 In case the reported disease will be assigned to several preferred terms, subjects will be 
counted for each individual preferred term. 
Previous conditions will be reported separately from concomitant ones. 
Individual subjects' listings of previous and concomitant diseases will be provided separately on 
the FAS. 
ADHD medical history will be summarized and listed separately on the FAS. 
10.3.4 Previous and concomitant medications 
Individual subject listing will be provided on the FAS.  


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Previous and concomitant medications (Section 8.4) will be summarized displaying counts and 
percentages of subjects having taken at least one treatment. A specific summary for previous and 
concomitant ADHD medication will be provided. 
Counts and percentages of subjects having taken at least one treatment will be presented by 
Anatomic Therapeutic Chemical (ATC) class 3 and individual preferred term within each ATC as 
well as by individual preferred term. The summary tables will be presented in descending order 
according to their incidence in the active treatment group (e.g., ATC and individual preferred term 
within each ATC with the highest number of occurrences appear first) sorting ties alphabetically. 
 
The counting of the medications will be handled as follows: 
 Subjects who took more than once the same medication (as qualified by its preferred 
term(s)) will be counted only once; 
 In case the reported medication is assigned to several preferred terms, subjects will be 
counted for each individual preferred term. 
Prohibited medications will be flagged in the listing with the concomitant medications and will be 
summarized separately as defined for concomitant medications above. Final list with prohibited 
medications will be provided by the Sponsor. 
10.3.5 Cognitive Performance Tests (Computer Test) 
Tests are performed at Baseline and Week 6 (prior to last dose). 
Frequency statistics will be provided for 'Stop Signal Task', 'Discounting Task', 'Psychomotor 
Vigilance Task', 'Time Production Task' and 'Time Reproduction Task' categories at Baseline and 
Week 6 for FAS population. 
Additionally, the number (%) of completers and non-completers of the test will will be evaluated 
by the answer 'Yes|No' to the question Cognitive performance tests performed?' respectively and 
will be presented in the summary table. The data are collected in the 'Cognitive Performance Tests' 
sections at baseline and Week 6. 
A listing with cognitive performance test results at each time point will be produced on FAS. 
10.4 EXPOSURE TO STUDY TREATMENT 
Treatment duration (days) as defined in section 8.5 will be listed and summarized on SAF using 
descriptive statistics for continuous variables, by treatment group 
10.5 COMPLIANCE WITH STUDY TREATMENT 
Compliance data will be summarized on SAF using descriptive statistics for categorical data as 
defined in Section 4.2.1. 
A listing of compliance will be provided on SAF. 
10.6 TRIAL DISCONTINUATION 
A summary of reasons for premature trial discontinuation will be provided for the RAN. The 
summary table will be presented in descending order in the active treatment group (i.e., the reason 
with the highest number of occurrences appears first). A listing of subjects who did not complete 
the study (see section 8.7) will be provided. 
10.7 PRIMARY EFFICACY ENDPOINT 
 
The primary analysis will be performed according to the intent-to-treat (ITT) principle on the FAS. 


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10.7.1 Statistical model and hypotheses 
The null hypothesis is that active MM-120 is not better than placebo; this will be rejected with a 
one-sided p-value < 0.10 with 80% power if the true efficacy of MM-120 reaches a standardized 
mean improvement over placebo of 0.60. 
10.7.2 Main analysis 
10.7.2.1 Estimand 
The primary estimand quantifies the treatment effect of MM-120 at 6-weeks vs placebo after twice 
weekly administration while accounting for intercurrent events (IEs) with potential confounding 
effects and IEs leading to study discontinuation prior to the 6-week assessment. 
The following attributes describe the primary estimand: 
● 
Population: Subjects in the FAS 
● 
Endpoint: Change from baseline to Week 6 in the AISRS Score 
● 
Treatment of interest: the randomized treatment MM-120 or placebo as a twice weekly 
treatment. 
● 
Handling of intercurrent events (IEs) prior to AISRS assessments. 
Depending on the IE causing the missing or potentially biased value, two sequential policy 
strategies will be applied: 
1. Policy strategy. Available data will be used; missing data will be imputed under a Missing 
At Random (MAR) assumption by borrowing information from subjects in the same 
treatment group in following cases: 
- IEs related to COVID-19 pandemic and other intercurrent missing data (see detals in 
Section 10.7.2.1.1). 
2. Policy strategy. Available data recorded after the IE will be set to missing; such missing 
data will be imputed/substituted under a Missing Not At Random (MNAR) assumption by 
borrowing information from the placebo arm subjects (reference-based imputation) in 
following cases: 
- Intake of prohibited medications/therapies with potential confounding effect (APPENDIX 
C) (see detals in Section 10.7.2.1.1). 
- Other IEs leading to treatment/study discontinuation (except those related to COVID- 19 
pandemic (see detals in Section 10.7.2.1.1). 
● 
Summary measure: Difference between MM-120 and placebo in mean change from 
baseline to Week 6 for AISRS Score. 
10.7.2.1.1 
Definition of intercurrent events (IEs) 
1. IEs related to COVID-19 pandemic are confirmed if: 
 - AE term AEDECOD is 'SARS-CoV-2 test positive' in the sdtm database. The AE start date 
AESTDTC will be considered to assign missing values (as defined in bullet 1 of Section 
10.7.2.2) to all assesments following this date and up to and including Week 6 D40. 


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2. Intake of prohibited medications/therapies  defined in APPENDIX C will be finalized and 
flagged accordingly on a case-by-case basis by a Sponsor medical review of the concomitant 
medications as defined in Section 8.4.3. The CM start date will be considered to assign missing 
values (as defined in bullet 2 of Section 10.7.2.2) to all assesments following this date and up 
to and including Week 6 D40. 
3. Other IEs leading to treatment/study discontinuation (except those related to COVID- 19 
pandemic) are confirmed if: 
the action taken AEACNOTH of the corresponding adverse event is 'DRUG DISCONTINUED' 
or 'SUBJECT WITHDRAWAL' in the sdtm database and subject had study assesments after 
the AE onset date AESTDTC and up to and including Week 6 D40. 
In all cases if the date of the assessment and the IE start date occur in the same date, this assessment 
values will be assigned to missing.  
If the date of assessments following the IE start date are missing, these will be imputed based on 
the theoretical date the assessments should have been occurred: 
 if the IE start date <= study day 9 then both Week 2 and 6 assessments have to be set to 
missing and imputed 
 if the IE start date is between study day 10 and 44 then Week 6 assessment has to be set to 
missing and imputed 
10.7.2.2 Analysis details 
Primary endpoint, change in AISRS score from baseline to Week 6, will be analyzed applying 
Rubin's rule to a multiple imputations procedure to appropriate contrasts based on Mixed Model 
for Repeated Measures (MMRM) analysis of covariance with the change in the AISRS score from 
baseline to Week 2 and Week 6 visits as dependent variable, and treatment group, visit, visit-by-
treatment group interaction, baseline score of AISRS, sex and age as fixed effects. An unstructured 
variance-covariance matrix will be used to model within-subject errors. Satterthwaite's method 
will be used to approximate the degrees of freedom. If convergence problems arise (even just in 
one imputed dataset) the following order of matrices will be applied: Heterogeneous TOEP 
(TOEPH), Toeplitz (TOEP), Autoregressive(1) (AR(1)). The same variance-covariance matrix 
will be used in sensitivity analyses. 
The imputation model include the longitudinal sequence of AISRS Scores, and the covariates used 
in the model as defined above. As a general approach, imputations are performed on observed 
values specifying a minimum and a maximum threshold (zero and 54 respectively) for AISRS. The 
change from baseline in AISRS Scores will not be imputed to avoid imputation of nonsensical 
values. For the imputation of missing data of AISRS, one thousand (1000) data sets will be 
generated, and the random seed number will be 200208. MI will be implemented following the 
steps below: 
1. Imputation assuming a MAR (policy strategy 1).  
MAR will be applied following the steps below: 
a)all assessments that took place after the IEs related to COVID-19 pandemic will be kept 
in the database;  
b)imputing all missing values already present in the data. 


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MI will be carried out based on fully conditional specification method (FCS, the details 
will be provided in the 'Programming standards and conventions' document). These 
datasets will be utilized in Step #2. 
2. Imputation assuming MNAR (policy strategy 2).  
MNAR will be applied following the steps below: 
a)assigning missing values to all assessments that took place after the IEs specified in 
policy strategy 2 above;  
b)imputing missing values assigned at step (a). 
MNAR assumption based on copy reference approach (i.e. using the non-missing values of 
the placebo arm) will be used. 
3. The MMRM model defined above will be run on each of the 1000 generated datasets with 
observed and imputed data. Rubin’s rule will be used for combining results to draw 
inference.  
In the evaluation of the primary endpoint will be included only subjects with NON missing baseline 
assessments. 
The LS Means along with associated standard errors (SE) and 95%CIs will be displayed for each 
treatment group at each time point. For the comparison of MM-120 vs placebo treatment effect, 
the LS Mean, SE, 95%CI and one-sided p-value will be provided.  
A listing of AISRS values overtime will be provided for the FAS population. 
10.7.3 Sensitivity analyses      
Sensitivity analyses will be implemented to assess the robustness of results on primary endpoint 
versus assumptions used in the statistical model for the main estimator. 
The following sensitivity analyses will be performed: 
 Tipping-point analysis: based on the assumption that subjects on active treatment who 
discontinue from the study perform worse by some amount than subjects of the same group 
remaining in the study (Section 10.7.3.1). 
 Copy reference approach: based on the assumption that subjects on active treatment with 
any missing data follow the distribution of the ones in the placebo group (Section 10.7.3.2). 
 Complete cases analysis (Section 10.7.3.3); 
 Main analysis on the PPS. 
 Main analysis stratified by ADHD severity at baseline. 
10.7.3.1  Tipping point sensitivity analysis 
For the imputation of missing data of AISRS, MI will be implemented assuming the MAR and 
imputing all missing data including missing data occurred/imputed after IEs as described in policy 
strategies 1 and 2. A delta-adjusted imputation method will be used applying progressive stress 
test to the MAR assumption of the main analysis. That is, a tipping-point analysis will be performed 
to see how severe departures from the MAR assumption should be to overturn the conclusions of 
the main analysis. It is assumed that study subjects from the MM-120 group with missing values 
would have, on average, their observed efficacy score worsened by some amount (delta) compared 


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with the efficacy score observed in study subjects of the same MM-120 group remaining in the 
study. A series of analysis models defiend above with progressively increasing deltas (δ= 0, 1, 2, 
3…. ; from less conservative to more conservative, where a delta of zero, δ(0), corresponds to the 
reference) will be run until the model results to be not significant (p-value ≥ 0.05). The delta 
adjustment will only be applied to the multiple-imputed values (based on the MAR assumption) of 
the subjects in the MM-120 group. Same linear mixed effects model defined for the main analysis 
will be used. 
The Tipping point analysis will be performed only in case the main analysis of the primary 
endpoint resulted significant.  
10.7.3.2 Copy reference 
A reference-based MI approach will be adopted considering a Missing Not at Random (MNAR) 
mechanism for all missing data of all IE events described in policy strategies 1 and 2: imputation 
of values in the MM-120 group will be done using the non-missing values of the placebo group 
(this approach will be referred as “Copy Reference”). This approach does not assume benefits for 
MM-120 in case of discontinuation and limits a post-discontinuation clinical effect to that of 
placebo. 
10.7.3.3 Complete cases 
The analysis of primary endpoint will be performed by fitting the MMRM on complete cases only 
(observed data) i.e.,  without implementing the MI and without the use of the “policy strategies”. 
10.7.3.4 Sensitivity analysis on the PPS population. 
Main analysis defined in Section 10.7.2 will be performed on the PPS population. 
10.7.3.5 Sensitivity analysis stratified by ADHD severity. 
Main analysis defined in Section 10.7.2 will be stratified by ADHD severity at baseline (see definition 
of subgroup populations in Section 9.3) and analysed on FAS. 
10.7.4 Other exploratory analyses 
Exploratory factor analysis will be used as a statistical data reduction technique to determine the 
underlying constructs of the AISRS scale measures. The maximum-likelihood factor analysis with 
orthogonal transformation will be used for extracton of factors.  Principal components analysis (PCA) 
with varimax rotation will be used to evaluate the factor structure of the AISRS. 
As factor analysis requires complete cases, multiple imputation will be used in case of missing data as 
described in Section 10.7.2.2.  
The analysis will be performed overall in two  randomized treatment groups as described in Section 9.1 
on FAS. The baseline AISRS scores will be used in current analysis. 
A table with AISRS items and corresponding factor loadings after variamx rotation in pca will be 
produced for each factor exctracted in the analysis. 
Distribution of the eigen values of the PCA will be reflected on Scree plot. 


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10.8 SECONDARY EFFICACY ENDPOINTS 
Change from baseline to Week 1 and 6 in AISRS, CGI-S, ASRS, and CAARS-L-SR are analyzed 
descriptively reporting by visit: n, mean, standard deviation, Q1 (25th percentile), Q3 (75th 
percentile), minimum, and maximum, and 95% Confidence Interval for the mean and for the 
median. For the active doses similar statistics will be reported for the difference from placebo. 
10.8.1 Key Secondary Endpoint 
10.8.1.1 Change from baseline in AISRS at Week 2 
The change from baseline (see Section 8.1.2) to Week 2 in AISRS Score will be analyzed using 
the same estimand and imputation process as the primary endpoint. The linear mixed effects model 
analysis of covariance (ANCOVA) with the change from baseline in the AISRS score at Week 2 
following randomization as dependent variable, and treatment group, baseline score of AISRS, sex 
and age as fixed effects will be used in current analysis. The outcome will be considered 
confirmatory, if in agreement with the primary endpoint outcome and provided that the null 
hypothis is rejected for the primary outcome. This gatekeeping function of the primary outcome 
allows to avoid any adjustment for multiplicity of testing. 
10.8.2  Other Secondary Endpoints 
10.8.2.1 Change in CGI-S from baseline to Week 2 and Week 6 
The change from baseline (see Section 11.2) to Week 2 and Week 6 will be summarized 
descriptively.  
The proportion of subjects having improved or having worsened/being stable will be calculated at 
each post-baseline assessment by treatment group. The proportion difference and the relative risk 
(LSD over placebo) with 2-sided 95% CIs will be displayed. The proportion of subjects in each 
category will be calculated at each post-baseline assessment based on the number of subjects with 
non-missing CGI-S score. 
A listing of CGI-S values over time will be provided for the FAS population. 
10.8.2.2 Change from baseline in ASRS and CAARS-L-SR to Week 2, 4 and 6 
The change in ASRS and CAARS-L-SR from baseline (see Section 11.2) to Week 2, 4 and 6 will 
be analyzed descriptively as indicated in section 8.9.1Error! Reference source not found. (in a
ddition, the 95% confidence interval for the mean and median will be reported). 
Separate listings of ASRS and CAARS-L-SR values overtime will be provided for the FAS. 
10.9 PHARMACOKINETICS 
 
The analyses of pharmacokinetic (PK) endpoints will be performed on the PKS (see definition in 
Section Error! Reference source not found.) population. The actual sampling time will be used f
or PK parameter calculation and graphical presentation of individual data. 
10.9.1 Pharmacokinetic Parameters 
The following PK parameters will be determined by non-compartmental analysis using individual 
concentration-time profiles: 
Table 7. Plasma Pharmacokinetic Parameters 
Parameter, Units 
Definition 
Method of Determination 


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Cmax, (ng/ml) 
Maximum observed drug 
concentration 
Observed value 
tmax, (h) 
Time to reach Cmax 
Actual elapsed time for 
observed Cmax in each period 
AUC0−t, (ng·hr/ml) 
Area under the 
concentration-time  curve 
from time zero to the 
measurable concentration 
time t 
AUC0−t will be calculated using 
the linear-up log-down 
trapezoidal interpolation 
method 
AUC0−inf, 
Area under the 
concentration-time curve 
from time zero to infinity 
(extrapolated) 
AUC0−inf (extrapolation of the 
AUC0−t ) will be calculated as 
AUC0−t + 
Ct
λt , where Ct is the 
last observed measurable 
concentration. 
AUC0-0.5h 
Area under the drug 
concentration-time curve 
from time zero to time 0.5h 
Calculated using linear-up log-
down trapezoidal summation 
from time zero to 0.5 hour post 
MM-120 administration 
AUC0-1h 
Area under the drug 
concentration-time curve 
from time zero to time 1h 
Calculated using linear-up log-
down trapezoidal summation 
from time zero to 1 hour post 
MM-120 administration 
AUC0-2h 
Area under the drug 
concentration-time curve 
from time zero to time 3h 
Calculated using linear-up log-
down trapezoidal summation 
from time zero to 2 hours post 
MM-120 administration 
AUC0-3h 
Area under the drug 
concentration-time curve 
from time zero to time 3h 
Calculated using linear-up log-
down trapezoidal summation 
from time zero to 3 hours post 
MM-120 administration 
AUC0-4h 
Area under the drug 
concentration-time curve 
from time zero to time 4h  
Calculated using linear-up log-
down trapezoidal summation 
from time zero to 4 hours post 
MM-120 administration 
AUC0-6h 
Area under the drug 
concentration-time curve 
from time zero to time 1h 
Calculated using linear-up log-
down trapezoidal summation 
from time zero to 6 hours post 
MM-120 administration 
t1/2, (hr) 
Terminal elimination half-
life  
ln(2)
λz
⁄
, where λz is the first-
order rate constant of drug 
associated with the terminal 
portion of the curve, see 
definition below. 
𝜆𝑧 
The observed elimination 
rate constant 
Estimated by linear regression 
through at least three data points 
(not including tmax) in the 
terminal phase of the log 
concentration-time profile; see 
additional criteria below.  


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10.9.1.1 Additional criteria for the observed elimination rate constant (𝝀𝒛) determination. 
This parameter will be the negative of the estimated slope of the linear regression of the ln-
transformed concentration versus time profile in the terminal elimination phase (log-linear 
regression after semilogarithmic transformation of the data using at least the last 3 data points of 
the terminal linear phase of the concentration-time curve.). Best fit method will be used to calculate 
the 𝝀𝒛  from at least 3 concentration data points including only data points after Cmax (tmax). Rsq 
adjusted, the goodness of fit statistic for the terminal elimination phase, adjusted for the number 
of points used in the estimation of 𝝀𝒛 must be ≥ 0.8. If the 𝝀𝒛 cannot be measured (e.g.: fewer than 
3 non-zero concentrations in the terminal elimination phase or Rsq adjusted < 0.8), the PK 
parameters derived from 𝝀𝒛 will not be reported for that individual PK profile (AUC0−inf, and t1/2). 
The timepoint where ln-linear 𝝀𝒛 calculation begins (𝝀𝒛 Lower) and the actual sampling time of 
the last measurable concentration used to estimate the 𝝀𝒛 (𝝀𝒛 Upper), as well as the Rsq adjusted 
for the ln-linear regression for the calculation of the elimination rate constant will be reported. 
10.9.2 Handling of Below Lower Limit of Quantification (BLOQ) values  
Concentration BLOQ will be imputed by 0 for the calculation of descriptive statistics, PK analyses 
and graphical presentation except for the geometric mean and the geometric CV, where it will be 
imputed as Lower Limit of Quantification (LLOQ)/2. 
If the concentrations before the first quantifiable concentration time point is BLOQ, the 
concentration will be set to 0. 
If the concentrations after the last quantifiable concentration time point is BLOQ, the concentration 
will be set to missing. 
If there are embedded BLOQ values between quantifiable concentrations, these BLOQ values will 
be set to missing. 
If there is a quantifiable concentration after 2 consecutive BLOQ values at the end of the profile, 
this quantifiable concentration and any further quantifiable concentration will be set to missing. 
 
Handling of other potential anomalies in the serum PK profiles will be discussed with the sponsor 
before PK parameter derivation.  
10.9.3  Summary Statistics 
Summary statistics include n, arithmetic mean, standard deviation (SD), geometric mean, 
coefficient of variation (CV), median, minimum and maximum. The CV will be expressed as a 
percentage and calculated as follows: 
CV of the arithmetic mean (%): 
SD
mean×100 
CV of the geometric mean (%): √exp (variance for log transformed data) −1 × 100 
A table with summaries  on PKS at “Week 1 D1” (first drug administration visit) will be presented 
with the following information: 
 MM-120 plasma concentrations; 
 
A table with summaries on PKS and in accordans with the definitions in Table 7 will be presented 
with the following information: 
 Terminal elimination half-life t1/2(hours) 
 Cmax; 
 tmax; 


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 AUC; 
 
Individual plots of MM-120 concentrations over actual sample time with all subjects on the same 
plot and separately per each subject's PK profile will be generated using linear and semi-
logarithmic scales (i.e. log y-axis) on PKS and sampling time (pre- and post-dose). 
Listings of individual MM-120 plasma concentrations and all parameters defined in Table 7 will be 
produced on PKS.  
10.10 PHARMACODYNAMICS 
 
Pharmacodynamic analysis (unless explicitly specified) will be performed on FAS population, in 
each treatment group. 
Pharmacodynamic descriptive statistics will include: n, mean, standard deviation, Q1 (25th 
percentile), Q3 (75th percentile), minimum, maximum, and 95% Confidence Interval for the mean 
and for the median. 
10.10.15 Dimensions of Altered States of Consciousness scale (5D-ASC). 
5D-ASC will be assessed at Week 1 Day 1 and Week 6, 6 hours after dosing (see Section 2.1.2). 
The scale consists of 94 items (questions) and is scored on a 0-100 mm VAS extrapolated to 100% 
scale for quantitative evaluation. Each item of the scale corresponds to one of the 5 dimensions 
defined below.  The descriptice statistics, as defined above, will be shown for 5 5D-ASC 
dimensions: 
1) Oceanic boundlessness – summation of questions 1, 3, 9, 12, 16, 18, 26, 34, 35, 36, 40, 41, 
42, 45, 50, 52, 57, 62, 63, 69, 71, 73, 81, 86, 87, 91, and 94. Maximum value = 2700. 
2) Anxious ego dissolution – summation of questions 6, 8, 21, 27, 32, 38, 43, 44, 46, 47, 53, 
56, 60, 64, 67, 78, 79, 80, 85, 88, and 89. Maximum value = 2100. 
3) Visionary destructuralization – summation of questions 7, 14, 20, 22, 23, 28, 31, 33, 39, 
54, 58, 70, 72, 75, 77, 82, 83, and 90. Maximum value = 1800. 
4) Auditory alterations – summation of questions 4, 5, 11, 13, 19, 25, 30, 48, 49, 55, 65, 66, 
74, 76, 92 and 93. Maximum value = 1600. 
5) Vigilance reduction – summation of questions 2, 10, 15, 17, 24, 29, 37, 51, 59, 61, 68, and 
84. Maximum value = 1200. 
The 5D-ASC Total Score will be calculated as the sum of all the questions.  The maximum value 
for the Total Score is 9400.   
Additionally, the number (%) of completers and non-completers of the questionarie will be 
evaluated by the answer 'Yes|No' to the question 'Was the 5D-ASC questionnaire completed by the 
subject? ' respectively and will be presented in the summary table. The data are collected in the 
'5D-ASC' CRF section. 
A spider-plot will be produced for graphical representation of 5 5D-ASC dimensions described 
above.  The mean of the scores in 5 dimensions defined above standardized to 0-100 scale (eg, ' 
Vigilance reduction' mean/1200*100) will be displayed on the spider plot.  
A listing of the 5D-ASC subscales and Total Score will be provided. 
10.10.2 Mystical Experience Questionnaire (MEQ),  drug effect Visual Analog Scale (VAS). 
Mystical Experience Questionnaire (MEQ) will be assessed at Week 1 Day 1 and Week 6, 6 hours 
after dosing (see Section 1.2.2). The descriptice statistics, as defined above, will be shown for 4 
MEQ scores and Total score (expressed on 100% scale): 


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1) Transcendence; 
2) Positive mood; 
3) Ineffability; 
4) Mystical; 
5) Total score. 
Additionally, the number (%) of completers and non-completers of the questionarie will will be 
evaluated by the answer 'Yes|No' to the question 'Was the MEQ 30 questionnaire completed by the 
subject?' respectively and will be presented in the summary table. The data are collected in the ' 
MEQ-30' CRF section. 
Box plot showing the distribution of MEQ scores in each treatment group will be produced. 
Visual Analog Scale (VAS) will be assessed at Baseline, at 0, 0.5, 1, 2, 3, 4 and 6 hours after dosing 
(see Section 2.1.2). The following 9 items will be used in VAS (0-100 mm) assessment of the 
score: 
1) Any drug effect; 
2) Good drug effect; 
3) Bad drug effect; 
4) Drug liking; 
5) Fear; 
6) Nausea; 
7) Alteration of vision; 
8) Alteration of sense of time; 
9) The boundaries between myself and my surroundings seem to blur. 
The descriptive statistics of scores (extrapolated to 100% scale) will be presented for each time 
point of assessment in each treatment group and overall. 
Additionally, the number (%) of completers and non-completers of the questionarie will will be 
evaluated by the answer 'Yes|No' to the question 'Was the VAS questionnaire completed by the 
subject?' respectively and will be presented in the summary table. The data are collected in the ' 
VAS' CRF section. 
10.11  EXPLORATORY ENDPOINTS 
Sleep quality/duration data are collected in the “Sleep Quality” CRF section and will be analyzed 
on FAS as continuous and categorical variable by treatment and visit as described in Section 8.10. 
10.12 SAFETY ENDPOINTS 
 
The AEs (adverse events) will be tabulated according to their System Organ Class (SOC) and 
Preferred Term (PT), in accordance with the Medical Dictionary for Regulatory Activities 
(MedDRA) coding. 
10.12.1 Adverse events 
Adverse events (AEs) will be summarized for treatment emergent adverse events (TEAEs). TEAEs 
are defined as AEs that occur on or after the day of the first dose. MedDRA terminology will be used 
to classify all AEs with respect to system organ class (SOC) and preferred term (PT).  
 
A summary of subjects with TEAEs will be presented for each treatment group. The summary will 
include counts and percentages for subjects who experience at least one AE, overall and by SOC and 
PT. This will be repeated for severe TEAEs, related TEAEs and serious TEAEs. Severity will be 
captured as Grade 1 through Grade 5 with Grades 3-5 categorized as severe. Related will be captured 


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as: none, unlikely, possibly or probably, with related = possibly or probably. Serious will be captured 
with the standard serious adverse event (SAE) criteria.  
 
The summary tables will be presented in descending order according to the incidence in the 'All' 
group (e.g., SOC and PT within each SOC with the highest number of occurrences will appear first). 
Equal frequency of different SOC/PTs will be sorted in alphabetical order of the SOC/PT. 
 
Subjects who report the same PT on multiple occasions will be counted once for the preferred term 
under the highest severity when summarizing by severity, under the closest relationship to the drug 
when summarizing by relationship, under most serious when summarizing by seriousness. 
 
Separate summary tables by SOC and PT will be provided for: TR-TEAEs, SAEs, and AEs leading 
to premature treatment discontinuation.  
Individual subject listings will be provided on SAF. 
10.12.1.1 
Subgroup analysis 
TEAEs, SAEs, AEs related to the study drug and AEs leading to premature treatment 
discontinuation will be tabulated on SAF by preferred term (PT) by treatment phase as follows: 
● Days of dosing: all AEs occurred on same date/visit of treatment but only during or after 
administration of study drug (with time on or after treatment administration). Week 1 D1 
(Dose 1), Week 1 D5 (Dose 2), Week 2 D8 (Dose 3), Week 2 D12 (Dose 4),  Week 3 D15 
(Dose 5), Week 3 D19 (Dose 6), Week 4 D22 (Dose 7), Week 4 D26 (Dose 8), Week 5 D29 
(Dose 9), Week 5 D33 (Dose 10), Week 6 D36 (Dose 11), Week 6 D40 (Last dose 12); 
This information will be pooled in summary table, i.e. all AEs occurred on/after all doses: 
first, second etc. until last dose; as well as will be summarized separately, i.e. AEs occurred 
on/after each dose: on/after first dose, on/after second dose etc. and until on/after last dose. 
● Non-dosing days: (a) all AEs with the date different from treatment administration date/visit 
defined above and until Week 10 Follow-up visit. (b) all AEs which occurred prior to study 
drug adminiatration (with time before administered dose) on dosing days.  
This information will be pooled in summary table, i.e. all AEs occurred between doses: first 
and second, second and third etc. until Week 10 Follow-up visit (EOS) or until Early 
Termination (ET) whatever comes earlier, as well as will be summarized separately, i.e. split 
by periods between doses: Dose 1 - Dose 2, Dose 2 - Dose 3, Dose 3 - Dose 4, Dose 4 - Dose 
5, Dose 5 - Dose 6, Dose 6 - Dose 7, Dose 7 - Dose 8, Dose 8 - Dose 9, Dose 9 - Dose 10, 
Dose 10 - Dose 11, Dose 11 - Dose 12, Dose 12 | last administered Dose - EOS | ET. 
In case of missing dates, the rules defined in Section 11.3.3 will be applied. In case of missing 
time of the AE or the treatment administration on the same day, the AE will be considered as 
occurred after the treatment administration, meaning will be summarized in 'Days of dosing' 
category. 
Frequency statistics will be presented by treatment group. The summary tables will be presented 
in descending order according to their incidence in the active treatment group of 'Days of dosing' 
treatment phase (e.g., individual preferred term with the highest number of occurrences appear 
first) sorting ties alphabetically. 
10.12.2 Vital signs 
Vital signs (defined in section 8.11.4), including changes from baseline (defined in section 11.1.1), 
will be listed and summarized on the SAF for each parameter separately, using descriptive statistics 


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for continuous data. In the evaluation of the absolute changes from baseline, only subjects with 
both the baseline and specific time point assessment will be included.  
10.12.3 Resting 12-lead ECG 
12-lead ECG parameters (defined in section 8.11.5) will be separately listed and summarized on 
SAF, using descriptive statistics for continuous data, absolute values and corresponding change 
from baseline at each time point. 
Treatment emergent ECG abnormalities (see definition in Section 8.11.5) will be summarized. 
10.12.4Laboratory 
 
Clinical laboratory data, abnormalities (defined in section 8.11.3) will be summarized on SAF. 
The percentage of subjects with values beyond clinically important limits will be summarized by 
frequency tables and shift tables (Normal, Abnormal not clinically significant, Abnormal clinically 
significant), as well as the abnormalities in general. Data will be also summarized for the absolute 
value and corresponding change from baseline at each scheduled assessment, using respective SI 
units. 
Individual listings will be produced for all parameters reporting flags of abnormal or out-of-range 
values. 
Listings of pregnancy test results will be presented.  
10.12.5 Physical examination 
All physical examination data will be listed on SAF by visits (Baseline, Week 6 and Week 10), 
with associated general assessment. If an abnormality is found, further details describing the signs 
and symptoms related to the abnormality will be specified. 
10.12.6  Columbia-Suicide Severity Rating Scale 
Columbia-Suicide Severity Rating Scale will be listed at Baseline, Week 2 D8, Week 2 D12, Week 
3 D15, Week 3 D19, Week 4 D22, Week 4 D26, Week 5 D29, Week 5 D33, Week 6 D36, Week 
6 D40, Week 10 Follow-up/Final visit for withdrawals on SAF. 
 
 
11 STUDY DEFINITIONS AND CONVENTIONS 
11.1 DEFINITIONS 
11.1.1 General definition of terms 
11.1.1.1 Screening date 
The screening date is the “Date of visit” in the "Demographics" CRF section.  
11.1.1.2 Study treatment start date (Day 1) 
Study treatment start date is the date of Week 1 D1 as collected in the “Date of visit” field in the 
section “Medical Events checks” when “LSD / Placebo administered” is ticked “Yes” in “Study 
Drug Administration” section.  


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11.1.1.3 Study treatment end date (EOT) 
This is the last day of study drug intake, which is the date reported in “Date of visit” field in section 
“Medical Events checks” (for each Visit form) when “LSD / Placebo administered” is ticked “Yes” 
in “Study Drug Administration” section.  
 
11.1.1.4 End-of-study (EOS) date  
The date of the Visit Week 10 Follow-up as reported on “Week 10 Follow-up” section, “Medical 
Events checks” CRF section. If no Week 10 Follow-up visit has been done, then the date reported 
in “Early termination date” included in the  “Termination Form” CRF section for premature 
withdrawals is used.  
11.1.1.5 Treatment period 
It is the period from the start date to the end date (limits included) of study treatment 
administration. 
11.1.1.6 Study Day 
The study day is the day of the event/assessment relative to the treatment start date.  
The study day is defined as:  
 The date of the event (visit date, onset date of an event, assessment date, etc.) – treatment 
start date + 1, if the event is on or after the treatment start date;  
 The date of the event (visit date, onset date of an event, assessment date, etc.) – treatment 
start date, if the event precedes the treatment start date.  
 
For dates prior to the treatment start, study day is the negative number of days elapsed between the 
date under consideration and the day of study treatment start. Therefore, the study day is always 
different from 0. 
11.1.1.7 Study-completer subject 
Refers to a subject who completed the study, i.e. subjects with answer “Yes” to the question 'Did 
the subject complete the study?' in the “Termination Form” CRF section. 
11.1.1.8 Baseline value 
Except where otherwise specified, baseline is defined as the last value measured or assessed before 
or on the date of the first dose of investigational drug administration at Visit 1. If the baseline visit 
takes place on the date of the first dose of investigational drug, then time should be considered, i.e. 
baseline date/time < first dose date/time. 
11.2 Derivation, algorithm and conversion rules 
11.2.1 Time since diagnosis 
Time since diagnosis (days) is defined as = Screening date – Date of diagnosis +1 (date of diagnosis 
from “ADHD Medical History” CRF section). 
 Missing/Partial diagnosis dates will be imputed according Section 11.3.3. 
11.2.2 Change from baseline 
Each change from baseline will be defined as difference between the value at each post-baseline 
assessment and the baseline value: 
Change from baseline= value at post-baseline visit-value at Baseline visit. 






























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13 APPENDICES 
APPENDIX A - TABLE, FIGURE AND LISTING LAYOUTS 
13.1 TABLE LAYOUTS 
13.1.1 Layout T1 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
 
MM-120 
N=xx 
Placebo 
N=xx 
All 
N=xx 
N (%) 
 
 
 
 
Screened Set (SCR) 
 
 
 
  Subjects Included 
 
 
xx (100%) 
 
 
 
 
 
 
 
 
Randomized Set (RAN)* 
 
 
 
  Subjects Included 
xx 
xx 
xx (yy.y) 
  Subjects Excluded 
 
 
xx (yy.y) 
 
 
 
 
Safety Set (SAF)** 
 
 
 
  Subjects Included 
xx 
xx 
xx (yy.y) 
  Subjects Excluded 
xx 
xx 
xx (yy.y) 
 
 
 
 
Full Analysis Set (FAS)** 
 
 
 
  Subjects Included 
xx 
xx 
xx (yy.y) 
  Subjects Excluded 
xx 
xx 
xx (yy.y) 
 
 
 
 
Per Protocol Set (PPS)*** 
 
 
 
  Subjects Included 
xx 
xx 
xx (yy.y) 
  Subjects Excluded 
xx 
xx 
xx (yy.y) 
 
 
 
 
Pharmacokinetic Analysis Set (PKS)^ 
 
 
 
  Subjects Included 
xx 
 
xx (yy.y) 
  Subjects Excluded 
xx 
 
xx (yy.y) 
 
 
 
 
*Percentages are calculated on the SCR 
**Percentages are performed on the RAN 
***Percentages are performed on the FAS 
^ Percentages are performed on the SAF 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
 
13.1.2 Layout T2 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
 
MM-120 
N=xx 
Placebo 
N=xx 
All 
N=xx 
N (%) 
 
 
 
 
Subjects screened 
xx 
xx 
xx (100%)  
 
 
 
 
Screen failures 
 
 
xx (yy.y) 
 
 
 
 
Subjects randomized 
xx 
xx 
xx (yy.y) 
 
 
 
 
Subjects treated 
xx 
xx 
xx (yy.y) 
 
 
 
 
Subjects who completed the study 
xx 
xx 
xx (yy.y) 
 
 
 
 
Subjects who prematurely discontinued 
the study, reasons: 
 
 
 
Lost to follow-up 
xx 
xx 
xx (yy.y) 
Death 
xx 
xx 
xx (yy.y) 
COVID-19 related 
xx 
xx 
xx (yy.y) 
Other 
xx 
xx 
xx (yy.y) 
 
 
 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
13.1.3 Layout T3 
Study MMED007 – Deliverables: <Deliverables> 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 63 of 96 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
 
MM-120 
N=xx 
N (%) 
Placebo 
N=xx 
N (%) 
All 
N=xx 
N (%) 
 
 
 
 
<categorical parameter> [n (%)] 
 
 
 
<category 1>                  
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
. 
 
 
 
. 
 
 
 
<category n> 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 
 
 
 
<continous parameter> (unit) 
 
 
 
n  
xx 
xx 
xx 
Mean     
xx.x 
xx.x 
xx.x 
Standard deviation  
xx.x 
xx.x 
xx.x 
Median 
xx.x 
xx.x 
xx.x 
Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for programmer:  
- 
For table “SDEM” use: sex at birth (male  | female) at screening, profession, highest education level (less than 
primary, primary, secondary, tertiary [bachelor, master, doctoral degree]) and country as categorical; age at 
screening as continuous. 
- 
For table “SBDC” use: Baseline values for the Adult Attention Deficit Investigator Symptom Rating Scale (AISRS), 
Clinical Global Impression - Severity of Illness Scale (CGI-S), Adult ADHD Self-Report Scale (ASRS) and Connors’ 
adult ADHD rating scale self-report long form (CAARS-L-SR) as continuous. <A/B/C/D/E/F/G/H> refer to scores on 
baseline 'Patient Reported Outcomes' eCRF page to be summarized in the table. In the table scores 
<A/B/C/D/E/F/G/H> should be reported as: A=Inattention/Memory Problems; B=Hyperactivity/Restlessness; 
C=Impulsivity/Emotional Lability; D=Problems with Self-Concept; E=DSM-IV Inattentive Symptoms; F=DSM-IV 
Hyperactive-Impulsive Symptoms; G=DSM-IV ADHD Symptoms Total; H=ADHD Index. 
- 
For table “SCPT” use: 'Stop Signal Task', 'Discounting Task', 'Psychomotor Vigilance Task', 'Time Production 
Task' and 'Time Reproduction Task' categories at Baseline and Week 6; the number (%) of completers and non-
completers of the test by the answer 'Yes|No' to the question Cognitive performance tests performed?. 
 
13.1.4 Layout T4 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
 
<Medical history/Concomitant diseases> 
 
System Organ Class / 
Preferred Term 
MM-120 
N=xx 
N (%) 
Placebo 
N=xx 
N (%) 
All 
N=xx 
N (%) 
 
 
 
 
ALL SYSTEM ORGAN CLASSES 
 
 
 
Total number of subjects with at least one <medical and 
psychiatric events | AE> 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 
 
 
 
System Organ Class 1 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
  <preferred term1>                   
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
  <preferred term2>                   
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 
 
 
 
System Organ Class n 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
  <preferred term1>                   
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
  <preferred term2>                   
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
System Organ Class and Preferred terms are based on MedDRA 25.1 dictionary. 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for programmer: display medical history and concomitant diseases in separate pages.  
Please use 'System Organ Class and' only in tables by SOC and PT and not in those only by PT.  
Please add footnote 'Treatment-emergent adverse events are events with onset date/time between the study treatment start 
date and the study treatment end date, limits included.' In the tables with treatment-emergent AEs.  
Please add footnote 'A Serious Adverse Reaction (SAR) is a serious adverse event that is determined to be related to the 
study treatment' to the table with Summary of serious adverse reaction (SAR) by system organ class (SOC) and individual 
preferred term (PT). 
13.1.5 Layout T5 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 64 of 96 
<Title> 
Analysis set: <analysis set> 
 
Anatomical Therapeutic Chemical Class / 
Preferred Term 
MM-120 
N=xx 
N (%) 
Placebo 
N=xx 
N (%) 
All 
N=xx 
N (%) 
 
 
 
 
ALL THERAPEUTIC CLASSES 
 
 
 
Total number of subjects with at least 
one medication 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
Total number of medication 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
 
 
 
 
ATC class 1 
 
 
 
  Total number of subjects with at least 
one medication 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
  Total number of medication 
xx 
xx 
xx 
  
 
 
 
  <preferred term1>                   
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
  <preferred term2>                   
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 
 
 
 
ATC class n 
 
 
 
  Total number of subjects with at least 
one medication 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
  Total number of medication 
xx 
xx 
xx 
  
 
 
 
  <preferred term1>                   
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
  <preferred term2>                   
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
ATC= Anatomical Therapeutic Chemical Class 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.1.6 Layout T6 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
 
 
MM-120 
N=xx 
Placebo 
N=xx 
 
 
 
Exposure (days) 
xx 
xx 
  n                  
xx.x 
xx.x 
  Mean               
xx.x 
xx.x 
  Standard Deviation 
xx.x 
xx.x 
  Standard Error     
xx.x 
xx.x 
  Median             
xx.x 
xx.x 
  Q1 , Q3            
xx.x, xx.x 
xx.x, xx.x 
  Min , Max          
xx.x, xx.x 
xx.x, xx.x 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.1.7 Layout T7 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
 
 
MM-120 
N=xx 
N (%) 
Placebo 
N=xx 
N (%) 
 
 
 
Subjects who did not complete the trial 
xx (yy.y) 
xx (yy.y) 
 
 
 
Reason for premature trial discontinuation 
 
 
Lost to follow-up  
xx (yy.y) 
xx (yy.y) 
Death  
xx (yy.y) 
xx (yy.y) 
COVID-19 related  
xx (yy.y) 
xx (yy.y) 
Other 
xx (yy.y) 
xx (yy.y) 
  xxx 
xx (yy.y) 
xx (yy.y) 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.1.8 Layout T8 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
Visit 
 
MM-120 
Placebo 
All 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 65 of 96 
Preferred Term 
N=xx 
N (%) 
N=xx 
N (%) 
N=xx 
N (%) 
 
 
 
 
ALL SYSTEM ORGAN CLASSES 
 
 
 
 Total number of subjects with at least one 
AE 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 <preferred term1>                   
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 <preferred term2>                   
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
Preferred terms are based on MedDRA 25.1 dictionary. 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.1.9 Layout T9 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
 
System organ class 
Preferred term 
MM-120 
N=xx 
N (%) 
Placebo 
N=xx 
N (%) 
All 
N=xx 
N (%) 
 
 
 
 
All deaths 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
System organ class 1 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 <preferred term1>                   
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 <preferred term2>                   
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
System organ class n 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 <preferred term1>                   
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 <preferred term2>                   
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 
 
 
 
System Organ Class and Preferred terms are based on MedDRA 25.1 dictionary. 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.1.10 Layout T10 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
Score: <A/B/C/D/E/F/G/H> 
Visit 
 
 
MM-120 
N=xx* 
 
Placebo 
N=xx* 
 
 
 
 
Baseline 
 
 
  n                  
xx 
xx 
  Mean               
xx.x 
xx.x 
  Standard deviation 
xx.x 
xx.x 
  Median             
xx.x 
xx.x 
  Q1, Q3              
xx.x, xx.x 
xx.x, xx.x 
  Min, Max           
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
Week <n> 
 
 
  n                  
xx 
xx 
  Mean               
xx.x 
xx.x 
  Standard deviation 
xx.x 
xx.x 
  Median             
xx.x 
xx.x 
  Q1, Q3              
xx.x, xx.x 
xx.x, xx.x 
  Min, Max           
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
Change from Baseline to Week <n> 
 
 
  n                  
xx 
xx 
  Mean               
xx.x 
xx.x 
  Standard deviation 
xx.x 
xx.x 
  Median             
xx.x 
xx.x 
  Q1, Q3              
xx.x, xx.x 
xx.x, xx.x 
  Min, Max           
xx.x, xx.x 
xx.x, xx.x 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for programmer: Table will be presented by week: only subjects with both the baseline and specific time point assessment 
will be included. <A/B/C/D/E/F/G/H> refer to scores on 'Patient Reported Outcomes' eCRF page to be summarized in the table. 
In the table scores <A/B/C/D/E/F/G/H> should be reported as: A=Inattention/Memory Problems; B=Hyperactivity/Restlessness; 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 66 of 96 
C=Impulsivity/Emotional Lability; D=Problems with Self-Concept; E=DSM-IV Inattentive Symptoms; F=DSM-IV Hyperactive-
Impulsive Symptoms; G=DSM-IV ADHD Symptoms Total; H=ADHD Index. 
Visit:  
For scores ASRS and CAARS-L-SR: Week 2, Week 4, Week 6. 
For scores AISRS and CGI-S: Week 2, Week 6. 
 
13.1.11Layout T11 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
 
 
MM-120 
N=xx 
N (%) 
Placebo 
N=xx 
N (%) 
 
 
 
Compliance (%) categories 
 
 
100% (12/12) 
xx (yy.y) 
xx (yy.y) 
91.7% (11/12) 
xx (yy.y) 
xx (yy.y) 
83.3% (10/12) 
xx (yy.y) 
xx (yy.y) 
etc. 
xx (yy.y) 
xx (yy.y) 
 
 
 
Number of subjects with at least one Special Situation 
xx (yy.y) 
xx (yy.y) 
 
 
 
Number of Special Situations 
xx 
xx 
  Special situation*: 
 
 
    Medication error or incorrect drug administration  
xx (yy.y) 
xx (yy.y) 
    Overdose 
xx (yy.y) 
xx (yy.y) 
    Deliberate abuse 
xx (yy.y) 
xx (yy.y) 
    Deliberate misuse 
xx (yy.y) 
xx (yy.y) 
    Drug interaction 
xx (yy.y) 
xx (yy.y) 
    Occupational exposure 
xx (yy.y) 
xx (yy.y) 
 
 
 
*Percentages are computed on ”Number of Special Situations” 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.1.12Layout T12 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
 
 
MM-120 
N=xx 
 
Placebo 
N=xx 
 
 
 
Baseline 
 
 
  n                  
xx 
xx 
  Mean               
xx.x 
xx.x 
  Standard deviation 
xx.x 
xx.x 
  Median             
xx.x 
xx.x 
  Q1, Q3              
xx.x, xx.x 
xx.x, xx.x 
  Min, Max           
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
Week 2 
 
 
  n                  
xx 
xx 
  Mean               
xx.x 
xx.x 
  Standard deviation 
xx.x 
xx.x 
  Median             
xx.x 
xx.x 
  Q1, Q3              
xx.x, xx.x 
xx.x, xx.x 
  Min, Max           
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
Change from Baseline to Week 2 
 
 
  n                  
xx 
xx 
  Mean               
xx.x 
xx.x 
  Standard deviation 
xx.x 
xx.x 
  Median             
xx.x 
xx.x 
  Q1, Q3              
xx.x, xx.x 
xx.x, xx.x 
  Min, Max           
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
Absolute Change (from ANCOVA model) 
 
 
LS Mean           
xx.x 
xx.x 
95% CL of LS Mean 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
TREATMENT EFFECT (MM-120 vs Placebo) 
 
 
p-value (based on ANCOVA model) 
x.xxxx 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
 
 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 67 of 96 
13.1.13Layout T13 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
Visit 
Category/Statistic 
Baseline 
 
 
0 
1 
2 
… 
6 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
<MM-120rm/Placebo > (N=xxx) 
 
 
 
 
 
Timepoint #1 
0  
## (##.#) 
## (##.#) ## (##.#) ## (##.#) ## (##.#) 
 
1 
## (##.#) 
## (##.#) ## (##.#) ## (##.#) ## (##.#) 
 
… 
## (##.#) 
## (##.#) ## (##.#) ## (##.#) ## (##.#) 
 
6 
## (##.#) 
## (##.#) ## (##.#) ## (##.#) ## (##.#) 
 
Missing 
## (##.#) 
## (##.#) ## (##.#) ## (##.#) ## (##.#) 
 
Improved 
## (##.#) 
 
 
 
 
 
95% CIs 
(##.#, ##.#) 
 
 
 
 
 
 
 
 
 
 
Timepoint #2 
0  
## (##.#) 
## (##.#) ## (##.#) ## (##.#) ## (##.#) 
 
1 
## (##.#) 
## (##.#) ## (##.#) ## (##.#) ## (##.#) 
 
… 
## (##.#) 
## (##.#) ## (##.#) ## (##.#) ## (##.#) 
 
6 
## (##.#) 
## (##.#) ## (##.#) ## (##.#) ## (##.#) 
 
Missing 
## (##.#) 
## (##.#) ## (##.#) ## (##.#) ## (##.#) 
 
Improved 
## (##.#) 
 
 
 
 
 
95% CIs 
(##.#, ##.#) 
 
 
 
 
 
 
 
 
 
 
 
Etc… 
## (##.#) 
## (##.#) ## (##.#) ## (##.#) ## (##.#) 
 
 
 
 
 
 
 
Percentages are based on N (number of patients in the analysis set) 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
13.1.14Layout T14 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
 
 
MM-120 
N=xx 
N (%) 
Placebo 
N=xx 
N (%) 
All 
N=xx 
N (%) 
 
 
 
 
Time since ADHD diagnosis, days 
 
 
 
 n  
xx 
xx 
xx 
 Mean     
xx.x 
xx.x 
xx.x 
 Standard deviation  
xx.x 
xx.x 
xx.x 
 Median 
xx.x 
xx.x 
xx.x 
 Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
Diagnostic criteria assessment according 
to DSMV 
 
 
 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 68 of 96 
 All criteria met 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 Not all criteria met 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 
 
 
 
Complete CAARS-S-OR at screening 
 
 
 
 Yes 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 No 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
  If ‘Yes': 
 
 
 
  A Score 
 
 
 
  n  
xx 
xx 
xx 
  Mean     
xx.x 
xx.x 
xx.x 
  Standard deviation  
xx.x 
xx.x 
xx.x 
  Median 
xx.x 
xx.x 
xx.x 
  Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
  Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
  B Score 
 
 
 
  n  
xx 
xx 
xx 
  Mean     
xx.x 
xx.x 
xx.x 
  Standard deviation  
xx.x 
xx.x 
xx.x 
  Median 
xx.x 
xx.x 
xx.x 
  Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
  Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
  C Score 
 
 
 
  n  
xx 
xx 
xx 
  Mean     
xx.x 
xx.x 
xx.x 
  Standard deviation  
xx.x 
xx.x 
xx.x 
  Median 
xx.x 
xx.x 
xx.x 
  Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
  Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
  D Score 
 
 
 
  n  
xx 
xx 
xx 
  Mean     
xx.x 
xx.x 
xx.x 
  Standard deviation  
xx.x 
xx.x 
xx.x 
  Median 
xx.x 
xx.x 
xx.x 
  Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
  Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
Current somatic disorder 
 
 
 
 Yes 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 No 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 
 
 
 
Previous hospitalization(s), previous 
disorders, (somatic and psychiatric), 
previous surgery(s) 
 
 
 
 Yes 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 No 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 
 
 
 
Family history (psychiatric and somatic) 
 
 
 
 Yes 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 No 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 
 
 
 
ADHD medication (prescription or non-
prescription) 
 
 
 
 Yes 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 No 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 
 
 
 
Alcohol, caffeine, nicotine: 
 
 
 
 Current Smoker 
 
 
 
 Yes 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 No 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
  Cigarettes per day 
 
 
 
 n  
xx 
xx 
xx 
 Mean     
xx.x 
xx.x 
xx.x 
 Standard deviation  
xx.x 
xx.x 
xx.x 
 Median 
xx.x 
xx.x 
xx.x 
 Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 Packs per year 
 
 
 
 n  
xx 
xx 
xx 
 Mean     
xx.x 
xx.x 
xx.x 
 Standard deviation  
xx.x 
xx.x 
xx.x 
 Median 
xx.x 
xx.x 
xx.x 
 Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 Coffee 
 
 
 
   Yes 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
   No 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 Coffee per day 
 
 
 
   n  
xx 
xx 
xx 
   Mean     
xx.x 
xx.x 
xx.x 
   Standard deviation  
xx.x 
xx.x 
xx.x 
   Median 
xx.x 
xx.x 
xx.x 
   Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
   Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 69 of 96 
 
 
 
 
 
 
 
 
 Alcohol (Beer, wine, liquor, ect.) 
 
 
 
   Yes 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
   No 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 Alcohol per week 
 
 
 
   n  
xx 
xx 
xx 
   Mean     
xx.x 
xx.x 
xx.x 
   Standard deviation  
xx.x 
xx.x 
xx.x 
   Median 
xx.x 
xx.x 
xx.x 
   Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
   Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
 
 
MDMA/Ecstasy 
 
 
 
 Yes 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 No 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 
 
 
 
Sedative, Narcotic (Benzos, Ketamine, 
Laughing gas (nitrous oxide)) 
 
 
 
 Yes 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 No 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 
 
 
 
Hallucinogenic (LSD, Mescaline, 
Psilocybin) 
 
 
 
 Yes 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 No 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 
 
 
 
Stimulants (Amphetamine, Cocaine, 
Methylphenidate (recreationally)) 
 
 
 
 Yes 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 No 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 
 
 
 
Opioids (Morphine, Diacetylmorphin, 
Codeine, Methadone) 
 
 
 
 Yes 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 No 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 
 
 
 
Cannabis, Marijuana, CBD 
 
 
 
 Yes 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 No 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 
 
 
Others: (GHB, PCP, DXM, Spice) 
 
 
 
Yes 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
No 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for Programmer: CAARS-S-OR scores should be reported in the table as: A-Score=DSM-IV Inattentive Symptoms; B-
Score=DSM-IV Hyperactive/Impulsive Symptoms; C-Score=DSM-IV ADHD Symptoms Total; D-Score=ADHD Index. 
13.1.15Layout T15 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
Visit 
 
 
MM-120 
N=xx 
N (%) 
Placebo 
N=xx 
N (%) 
All 
N=xx 
N (%) 
 
 
 
 
 
Test performed 
 
 
 
 Yes 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
No  
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
Missing 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
Stop signal task 
 
 
 
 Done 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 Not done 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
Missing 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
Discounting task 
 
 
 
 Done 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 Not done 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
missing 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
Psychomotor Vigilance Task 
 
 
 
 Done 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 Not done 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
Missing 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 70 of 96 
 
 
 
 
Time Production Task 
 
 
 
 Done 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 Not done 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
Missing 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
Time Reproduction Task 
 
 
 
 Done 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 Not done 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
Missing 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for Programmer: Visit = Baseline, Week 6. Please report No/Note done only if such data is available in the data. If 
it is not available, report Yes/Done values and missing for subjects where no data is available in the data set. All 
percentages should be calculated on the N. 
13.1.16Layout T16 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
Severe ADHD (AISRS score at baseline ≥ 38) |  Moderate ADHD (AISRS score at baseline < 38) 
 
Visit 
Treatment group 
n 
LS Mean 
SE 
95% CL 
               Difference to placebo 
LSMean           SE         95% CL     p-value* 
 
 
 
 
 
 
 
 
 
Change from Baseline 
to Week 6 
 
 
 
 
 
 
 
 
MM-120 
xx 
xx.x  
xx.x  
[xx.x, 
xx.x] 
xx.x 
xx.x 
[xx.x, 
xx.x] 
0.xxx 
Placebo 
xx 
xx.x 
xx.x 
[xx.x, 
xx.x] 
- 
- 
- 
- 
 
 
 
 
 
 
 
 
 
*p-value is one-sided 
**MMRM=Mixed Model for Repeated Measures 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for programmer: 
-for “MMRMAISRS” dependent variable is AISRS Score (analysis performed on FAS);  
-for “MMRMMAR” dependent variable is AISRS Score, with MAR assumption (analysis performed on FAS); add Footnote: *** MAR= 
Missing At Random. 
-for “MMRMMNAR” dependent variable is AISRS Score, with MNAR assumption (analysis performed on FAS); add Footnote: *** 
MNAR= Missing Not At Random. 
-for “MMRMCP” dependent variable is AISRS Score, completed cases (analysis performed on FAS) 
-for “MMRMAISRS” dependent variable is AISRS Score (analysis performed on PPS) 
 
Please use subgroups 'Severe ADHD (AISRS score at baseline ≥ 38) |  Moderate ADHD (AISRS score at baseline < 38)' in the 
sensitivity analysis of the MMRMAISRSSEV 
 
13.1.17Layout T17 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
 
 
Number of Subjects considered in the model 
 
MM-120 
xx 
Placebo 
xx 
 
 
 
 
Difference to placebo 
Shift values 
 
LSMean 
SE 
95% CL 
p-value 
   0 
 
xx.x 
xx.x 
[xx.x, 
xx.x] 
0.xxx 
   1 
 
xx.x 
xx.x 
[xx.x, 
xx.x] 
0.xxx 
   2 
 
xx.x 
xx.x 
[xx.x, 
xx.x] 
0.xxx 
   3 
 
xx.x 
xx.x 
[xx.x, 
xx.x] 
0.xxx 
   … 
 
xx.x 
xx.x 
[xx.x, 
xx.x] 
0.xxx 
 
 
Note 1: Analysis is based on a Tipping Point analysis for primary endpoint 
Note 2: Tipping point is performed until the MMRM model results to be not significant (p-value ≥ 0.05). 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for programmer:  


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 71 of 96 
The Tipping point analysis will be performed only in case the main analysis of the primary endpoint (MMRMAISRS) resulted 
significant, p-value < 0.05. 
The vector of shift values will include the values: (δ= 0, 1, 2, 3…) until the first value when MMRM model results to be 
not significant (p-value ≥ 0.05). 
13.1.18Layout T18 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
Visit  
 
 
MM-120 
N=xx 
N (%) 
Placebo 
N=xx 
N (%) 
All 
N=xx 
N (%) 
 
 
 
 
 
Completers 
 
 
 
 n 
xx 
xx 
xx 
 
 
 
 
Oceanic boundlessness 
 
 
 
  n  
xx 
xx 
xx 
  Mean, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Standard deviation  
xx.x 
xx.x 
xx.x 
  Median, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
  Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
 
 
Anxious ego dissolution 
 
 
 
  n  
xx 
xx 
xx 
  Mean, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Standard deviation  
xx.x 
xx.x 
xx.x 
  Median, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
  Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
 
 
Visionary destructuralization 
 
 
 
  n  
xx 
xx 
xx 
  Mean, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Standard deviation  
xx.x 
xx.x 
xx.x 
  Median, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
  Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
 
 
Auditory alterations 
 
 
 
  n  
xx 
xx 
xx 
  Mean, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Standard deviation  
xx.x 
xx.x 
xx.x 
  Median, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
  Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
 
 
Vigilance reduction 
 
 
 
  n  
xx 
xx 
xx 
  Mean, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Standard deviation  
xx.x 
xx.x 
xx.x 
  Median, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
  Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
Total Score 
 
 
 
  n  
xx 
xx 
xx 
  Mean, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Standard deviation  
xx.x 
xx.x 
xx.x 
  Median, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
  Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for Programmer: Visit = Week 1 Day 1, Week 6 
13.1.19Layout T19 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
Visit  
 
 
MM-120 
N=xx 
N (%) 
Placebo 
N=xx 
N (%) 
All 
N=xx 
N (%) 
 
 
 
 
 n 
xx 
xx 
xx 
 
 
 
 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 72 of 96 
Transcendence 
 
 
 
  n  
xx 
xx 
xx 
  Mean, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Standard deviation  
xx.x 
xx.x 
xx.x 
  Median, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
  Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
 
 
Positive mood 
 
 
 
  n  
xx 
xx 
xx 
  Mean, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Standard deviation  
xx.x 
xx.x 
xx.x 
  Median, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
  Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
 
 
Ineffability 
 
 
 
  n  
xx 
xx 
xx 
  Mean, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Standard deviation  
xx.x 
xx.x 
xx.x 
  Median, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
  Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
 
 
Mystical 
 
 
 
  n  
xx 
xx 
xx 
  Mean, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Standard deviation  
xx.x 
xx.x 
xx.x 
  Median, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
  Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
Total Score 
xx 
xx 
xx 
  n  
xx 
xx 
xx 
  Mean, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Standard deviation  
xx.x 
xx.x 
xx.x 
  Median, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
  Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for Programmer: Visit = Week 1 D1, Week 6 
13.1.20Layout T20 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
Timepoint x.xh (hours*) 
 
 
 
 
 
MM-120 
N=xx 
N (%) 
Placebo 
N=xx 
N (%) 
All 
N=xx 
N (%) 
 
 
 
 
Completers 
 
 
 
 n 
xx 
xx 
xx 
 
 
 
 
 Item n  
 
 
 
  n  
xx 
xx 
xx 
  Mean, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Standard deviation  
xx.x 
xx.x 
xx.x 
  Median, 95% CL     
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
xx.x [xx.x, xx.x] 
  Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
  Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for programmer:  
-Item 1: Any drug effect; 
-Item 2: Good drug effect; 
-Item 3: Bad drug effect; 
-Item 4: Drug liking; 
-Item 5: Fear; 
-Item 6: Nausea; 
-Item 7: Alteration of vision; 
-Item 8: Alteration of sense of time; 
-Item 9: The boundaries between myself and my surroundings seem to blur; 
Timepoint x.xh: Week 1 Day 1, hours* 0, 0.5, 1, 2, 3, 4, 6. 
13.1.21Layout T21 
Study MMED007 – Deliverables: <Deliverables> 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 73 of 96 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
 
 
MM-120 
N=xx 
N (%) 
Placebo 
N=xx 
N (%) 
All 
N=xx 
N (%) 
 
 
 
 
Week <n> 
 
 
 
 
 
 
 
Sleep quality, continuous scale  
 
 
 
  n  
xx 
xx 
xx 
  Mean  
xx.x  
xx.x  
xx.x  
  Standard deviation  
xx.x 
xx.x 
xx.x 
  Median  
xx.x  
xx.x  
xx.x  
  Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
  Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
Sleep quality,  categorical scale  
 
 
 
terrible 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
poor 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
fair 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
good 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
excellent 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
Missing 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
Sleep duration, hours 
 
 
 
  n  
xx 
xx 
xx 
  Mean  
xx.x  
xx.x  
xx.x  
  Standard deviation  
xx.x 
xx.x 
xx.x 
  Median  
xx.x  
xx.x  
xx.x  
  Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
  Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
The respondent marks, an integer score from 0 to 10, are defined according to the following five categories: 0 = terrible, 
1–3 = poor, 4–6 = fair, 7–9 = good, 10  = excellent. 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for programmer: Sleep quality corresponds to the question 'How well did the patient sleep that night?' and duration 
to the question 'How many hours did the patient approximately sleep that night?' on the 'Sleep Quality' eCRF page. 
“Missing” category is shown only if there are missing sleep quality values. 
13.1.22Layout T22 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
<parameter (unit)> 
 
 
MM-120 
N=xx 
Placebo 
N=xx 
 
 
 
Visit 
 
 
 
 
 
Baseline 
 
 
  n                  
xx 
xx 
  Mean               
xx.x 
xx.x 
  Standard deviation 
xx.x 
xx.x 
  Median             
xx.x 
xx.x 
  Q1, Q3              
xx.x, xx.x 
xx.x, xx.x 
  Min, Max           
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
Week <n> 
 
 
  n                  
xx 
xx 
  Mean               
xx.x 
xx.x 
  Standard deviation 
xx.x 
xx.x 
  Median             
xx.x 
xx.x 
  Q1, Q3              
xx.x, xx.x 
xx.x, xx.x 
  Min, Max           
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
Change from Baseline to Week <n> 
 
 
  n                  
xx 
xx 
  Mean               
xx.x 
xx.x 
  Standard deviation 
xx.x 
xx.x 
  Median             
xx.x 
xx.x 
  Q1, Q3              
xx.x, xx.x 
xx.x, xx.x 
  Min, Max           
xx.x, xx.x 
xx.x, xx.x 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for programmer: 
-for “LAB”, table will be presented by week: only subjects with both the baseline and specific time point assessment will 
be included;  


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 74 of 96 
-For “Vital Sign”, table will be presented by week: only subjects with both the baseline and specific time point 
assessment will be included. 
13.1.23Layout T23 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
Visit 
Abnormality category finding 
MM-120 
N=xx 
N (%) 
Placebo 
N=xx 
N (%) 
 
 
 
Subjects with at least one finding 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 
 
<Category 1> 
xx (yy.y) 
xx (yy.y) 
 Finding 1 
xx (yy.y) 
xx (yy.y) 
 … 
xx (yy.y) 
xx (yy.y) 
 Finding n 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 
 
<Category n> 
xx (yy.y) 
xx (yy.y) 
 Finding 1 
xx (yy.y) 
xx (yy.y) 
 … 
xx (yy.y) 
xx (yy.y) 
 Finding n 
xx (yy.y) 
xx (yy.y) 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for Programmer: Visit = Baseline, Week 6 
13.1.24Layout T24 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
 
 
MM-120 
N=xx 
N (%) 
Placebo 
N=xx 
N (%) 
All 
N=xx 
N (%) 
 
 
 
 
 
 
 
 
ADHD medication (prescription or non-
prescription) 
 
 
 
 Yes 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 No 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
If ‘Yes': 
 
 
 
Name of medication/therapy 
 
 
 
 Indication 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
  Total daily dose (Unit) 
 
 
 
   n  
xx 
xx 
xx 
   Mean     
xx.x 
xx.x 
xx.x 
   Standard deviation  
xx.x 
xx.x 
xx.x 
   Median 
xx.x 
xx.x 
xx.x 
   Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
   Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
 
 
  Amount taken in the morning 
 
 
 
   n  
xx 
xx 
xx 
   Mean     
xx.x 
xx.x 
xx.x 
   Standard deviation  
xx.x 
xx.x 
xx.x 
   Median 
xx.x 
xx.x 
xx.x 
   Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
   Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
  Amount taken in the afternoon 
 
 
 
   n  
xx 
xx 
xx 
   Mean     
xx.x 
xx.x 
xx.x 
   Standard deviation  
xx.x 
xx.x 
xx.x 
   Median 
xx.x 
xx.x 
xx.x 
   Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
   Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
  Amount taken in the night time 
 
 
 
   n  
xx 
xx 
xx 
   Mean     
xx.x 
xx.x 
xx.x 
   Standard deviation  
xx.x 
xx.x 
xx.x 
   Median 
xx.x 
xx.x 
xx.x 
   Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
   Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 75 of 96 
13.1.25Layout T25 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
 
 
MM-120 
N=xx 
 
 
MM-120 plasma concentration at Week 1 Day 1, ng/ml 
 
 
 
   
Pre-dose: 0 hours 
 
n                  
xx (xx.x) 
  Mean (StD)         
xx.x 
  CV of mean 
xx.x 
  Geometric mean (CV) 
xx.x (xx.x) 
  Median             
xx.x 
  Min , Max          
xx.x, xx.x 
 
 
Time after dose: xx hours 
 
n                  
xx (xx.x) 
  Mean (StD)         
xx.x 
  CV of mean 
xx.x 
  Geometric mean (CV) 
xx.x (xx.x) 
  Median             
xx.x 
  Min , Max          
xx.x, xx.x 
 
 
StD=Standard Deviation; CV=Coefficient of Variation 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.1.26Layout T26 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
 
 
MM-120 
N=xx 
 
 
   
Parameter n, units 
 
n                  
xx (xx.x) 
  Mean (StD)         
xx.x 
  CV of mean 
xx.x 
  Geometric mean (CV) 
xx.x (xx.x) 
  Median             
xx.x 
  Min , Max          
xx.x, xx.x 
 
 
StD=Standard Deviation;  
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for Programmer: Parameter n1=Cmax, ng/ml; n2=Tmax, h; n3=t1/2, h; n4=AUC0-inf, ng·h/ml; n5=AUC0-0.5h, ng·h/ml; 
n6=AUC0-1h, ng·h/ml; n7=AUC0-2h, ng·h/ml; n8=AUC0-3h, ng·h/ml; n9=AUC0-4h, ng·h/ml; n10=AUC0-6h, ng·h/ml.  
13.1.27Layout T27 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
 
 
Treatment Phase 
 
Days of dosing* 
Non-dosing days** 
 
Preferred Term 
MM-120, 
N=xx 
N (%) 
Placebo 
N=xx 
N (%) 
MM-120, 
N=xx 
N (%) 
Placebo 
N=xx 
N (%) 
 
 
 
 
 
ALL Preferred Terms 
 
 
 
 
 Total number of subjects 
with at least one AE 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 
 
 
 
 
Dose 1 for Days of dosing |  
Period between Dose 1 and 
Dose 2 for Non-dosing days 
 
 
 
 
 <preferred term1>              
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 <preferred term2>              
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
… 
 
 
 
 
 
 
Dose n for Days of dosing | 
Period between Dose m and 
Dose n for Non-dosing days 
 
 
 
 
 <preferred term1>              
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
 <preferred term2>              
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 
xx (yy.y) 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 76 of 96 
… 
 
 
 
 
 
 
 
 
 
 
*Days of dosing: all adverse events (AEs) occurred on same date/visit of treatment but only during or 
after administration of study drug; 
**Non-dosing days:(a) all AEs with the date different from treatment administration date/visit until 
Week 10 Follow-up visit; (b) all AEs which occurred prior to study drug adminiatration on dosing days. 
***Period between last administered Dose and end of treatment (ET): in this category reported all patients who 
discontinued study treatment preliminary  
Preferred terms are based on MedDRA 25.1 dictionary. 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
Note for programmer:  
1)for Treatment Phase 'Days of dosing': the AEs should be polled for all doses taken and should be split by dose n: Dose 
1 correspond to dose administered at visit Week 1 D1, Dose 2 at visit Week 1 D5, Dose 3 at visit Week 2 D8, Dose 4 at 
visit Week 2 D12,  Dose 5 at visit Week 3 D15, Dose 6 at visit Week 3 D19, Dose 7 at visit Week 4 D22, Dose 8 at visit 
Week 4 D26, Dose 9 at visit Week 5 D29, Dose 10 at visit Week 5 D33, Dose 11 at visit Week 6 D36, Dose 12 at visit Week 6 
D40 (Last dose);  
2)for Treatment Phase 'Non-dosing days': all AEs should be pooled for all doses taken and should be split by periods 
between doses m and n: Dose 1 - Dose 2, Dose 2 - Dose 3, Dose 3 - Dose 4, Dose 4 - Dose 5, Dose 5 - Dose 6, Dose 6 - Dose 
7, Dose 7 - Dose 8, Dose 8 - Dose 9, Dose 9 - Dose 10, Dose 10 - Dose 11, Dose 11 - Dose 12, Dose 12|last dose - EOS|ET. 
Non dosing AEs correspond to (a)all AEs occurred on same date/visit of treatment administration as defined above, but 
with time before administered dose; (b)all AEs with the date different from treatment administration date/visit defined 
above and until Week 10 Follow-up. 
 
Please report this footnote if such category has appeared in the table***Period between last administered Dose and end of 
treatment (ET): in this category reported all patients who discontinued study treatment preliminary  
 
13.1.28Layout T28 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
<Hematology/Chemistry> 
Visit 
 
 
Category/Statistic 
MM-120 
N=xx 
N (%) 
Placebo 
N=xx 
N (%) 
All 
N=xx 
N (%) 
 
 
 
 
 
 
 
 
 
<Parameter>(Unit) 
 
 
 
n 
## 
## 
## 
L  
##.# 
##.# 
##.# 
LL 
##.# 
##.# 
##.# 
H 
 
 
 
HH 
 
 
 
 
 
 
 
Labels "L", "LL", "H" and "HH" display the increasing grade (severity) of abnormally low ("L", "LL"), or high values 
("H", and "HH") for each of the laboratory parameters 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.1.29Layout T29 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
Category/Statistic 
Baseline 
 
 
Normal 
Abnormal 
NCS 
Abnormal 
CS 
Total non-
missing 
Missing 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
<MM-120rm/Placebo > 
(N=xxx) 
n=xxx 
 
 
 
 
 
Timepoint #1 – n (%) 
Normal  
## 
(##.#) 
## (##.#) 
## (##.#) 
## (##.#) 
## 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 77 of 96 
 
Abnormal NCS 
## 
(##.#) 
## (##.#) 
## (##.#) 
## (##.#) 
## 
 
Abnormal CS 
## 
(##.#) 
## (##.#) 
## (##.#) 
## (##.#) 
## 
 
Total non-
missing 
## 
(##.#) 
## (##.#) 
## (##.#) 
## 
## 
 
Missing 
## 
## 
## 
## 
## 
 
n=xxx 
 
 
 
 
 
Timepoint #2 – n (%) 
Normal  
## 
(##.#) 
## (##.#) 
## (##.#) 
## (##.#) 
## 
 
Abnormal NCS 
## 
(##.#) 
## (##.#) 
## (##.#) 
## (##.#) 
## 
 
Abnormal CS 
## 
(##.#) 
## (##.#) 
## (##.#) 
## (##.#) 
## 
 
Total non-
missing 
## 
(##.#) 
## (##.#) 
## (##.#) 
## 
## 
 
Missing 
## 
## 
## 
## 
## 
 
 
 
 
 
 
 
Etc… 
n=xxx 
## 
(##.#) 
## (##.#) 
## (##.#) 
## (##.#) 
## 
 
 
 
 
 
 
 
CS= Clinically Significant. 
n is the number of subjects with non-missing assessment. 
Percentages are based on the number of subjects with non-missing assessment (n) in each treatment/visit 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.1.30Layout T30 
Study MMED007 – Deliverables: <Deliverables> 
Table <Number of table> 
<Title> 
Analysis set: <analysis set> 
 
Item Number 
 
Wording 
 
Factor 1 
 
… 
 
Factor m 
 
 
 
 
 
  Sabscale 1 
 
 
 
 
 
Item 1                 
XXX 
xx.x 
xx.x 
xx.x 
  …         
… 
… 
… 
… 
Item n 
XXX 
xx.x 
xx.x 
xx.x 
… 
 
 
 
 
 
 
 
 
 
  Subscale 2 
 
 
 
 
 
Item 1                 
XXX 
xx.x 
xx.x 
xx.x 
  …         
… 
… 
… 
… 
Item n 
XXX 
xx.x 
xx.x 
xx.x 
 
 
 
 
 
The maximum-likelihood factor analysis with orthogonal transformation was used for extracton of factors.  Principal 
components analysis (PCA) with varimax rotation was used to evaluate the factor structure of the AISRS. Only itmes with 
loading factor ≥|0.4| are reported. 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for programmer: number of factors to be presented in the table depends on the results (see SAP for details). Wording 
(XXX) corresponds to item on the 'AISRS' eCRF page. Item number can take values from 1 to 18 corresponding to eeach 
particular wording. Values to be presented in columns Factor 1 - Factor m are factor loadings after variamx rotation in 
pca. 
 
 
 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 78 of 96 
13.2 LISTING LAYOUTS 
13.2.1 Layout L1 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subject ID 
Screened 
Failure 
Randomized 
Treated 
Prematurely 
discontinued 
the study ( 
reasons) 
Completed study 
 
Reason 
 
 
 
 
 
 
 
xxx 
Yes/No 
Yes/No 
Yes/No 
Yes/No 
Yes(xxxxx)/No 
Yes/No: 
 
xxxxxx 
 
 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.2.2 Layout L2 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subject ID 
Randomized 
Treatment 
 
 
 
Date / time 
Protocol Violation 
Violations leading 
to 
exclusion from PPS 
Violations 
leading to 
exclusion 
from PKS 
 
 
 
 
 
 
xxx 
xxx 
ddmmyyyy/hh:mm 
xxxxxxxxx 
Yes/No 
Yes/No 
 
 
 
 
 
 
 
 
ddmmyyyy/hh:mm 
xxxxxxxxx 
Yes/No 
Yes/No 
 
 
… 
… 
… 
… 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.2.3 Layout L3 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subject ID 
Randomized 
Treatment 
Sex 
Age (years) 
Profession 
Highest 
education 
level 
Country 
 
 
 
 
 
 
 
xxx 
xxxxxxx 
xx 
xx 
xxxxxx 
xxxxxx 
xxxxx 
 
 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.2.4 Layout L4 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subject 
ID 
Randomized Treatment 
AISRS 
CGI-S 
ASRS 
CAARS-L-SR 
(A/B/C/D/E/F/G/H)  
 
 
 
 
 
 
 
 
xxx 
xxxxxxx 
xx 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for programmer: <A/B/C/D/E/F/G/H> refer to Connors’ adult ADHD rating scale self-report long form (CAARS-L-SR) 
scores on baseline 'Patient Reported Outcomes' eCRF page. In the listing scores <A/B/C/D/E/F/G/H> should be reported as: 
A=Inattention/Memory Problems; B=Hyperactivity/Restlessness; C=Impulsivity/Emotional Lability; D=Problems with Self-
Concept; E=DSM-IV Inattentive Symptoms; F=DSM-IV Hyperactive-Impulsive Symptoms; G=DSM-IV ADHD Symptoms Total; H=ADHD 
Index. 
13.2.5 Layout L5 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 79 of 96 
Subject 
ID 
Randomized 
Treatment 
System 
Organ Class  
Preferred 
Term 
Reported 
Term 
Start date 
End date 
Ongoing 
 
 
 
 
 
 
 
 
xxx 
xxxxx 
xxxxxxxxx  
xxxxxxxxx  
xxxxxxxxx  
ddmmyyyyy 
ddmmyyy 
Yes/No 
 
 
 
 
 
 
 
 
Medical or surgical History is coded using Medical Dictionary for regulatory activities (MedDRA 25.1) dictionary latest 
version. 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for programmer: display medical history and concomitant diseases in separate pages 
13.2.6 Layout L6 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
  
 
Subject 
ID 
Randomized 
Treatment 
ATC Class/ 
Preferred 
Term/ 
Medication 
name 
Start 
date 
Ongoing 
 
Stop 
date 
 
 
Prohibited  
therapy 
 
 
Reason for 
admistration  
 
Specification* 
 
Medication for 
ADHD**/ 
Dose (Unit)/ 
Frequency^/ 
Route^^ 
Medication given 
for the 
treatment of an 
AE/Medical 
History 
 
If yes: 
AE/ Medical 
History 
Reference(Report 
term and start 
date)   
 
 
 
 
 
 
 
 
 
 
xxx 
xxxxxxx 
xxxxxxxxx/ 
xxxxxxxxx/ 
xxxxxxxxx 
ddmmyyyy 
Yes/No: 
ddmmyyyy 
 
 
 
 
 
Yes/No  
 
Adverse Event, 
Prophylaxis, 
Medical History, 
Other: 
 
xxxxxxxxx 
 
Yes/No / 
xx.x (Unit+)  / 
xxxxx++  xxxxxxx^/ 
xxxxx+++  xxxxxxx^^ 
No/Yes: 
xxxxxxxx (xxxx, 
ddmmyyyy) 
 
 
 
 
 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for programmer: 
Don’t show the following symbol in the listing. They are specified for a better programming understanding. 
*If answer to "Reason for administration" is “Other” 
**If answer to "Reason for administration" is “Medical History” or “Other” 
+Unit can be “mg”, “mcg”, “g”, “mL”, “Tab”, “IU”, “Capsule”, “Puff”, if answer to "Unit" is “Other” include the text 
specified 
++Frequency can be “QD”, “QOD”, “QID”, “BID”, “TID”, “PRN”, “Once per week”, “Monthly”, “As needed”, if answer to "Unit" 
is “Other” include the text specified 
+++Route can be “P.O. ”, “SC”, “IM”, “IV”, “Rectal”, “Topical”, “Nasal”, “Inhaled”, “Sublingual”, “Transdermal”, 
“Intraocular”, if answer to "Unit" is “Other” include the text specified 
13.2.7 Layout L6a 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
  
 
Subject 
ID 
Randomized 
Treatment 
ATC Class/ 
Preferred 
Term/ 
Medication 
name 
Date of 
Last 
Dose 
Total Daily Dose 
(Unit) 
Morning 
Amount taken in 
the: 
 
Afternoon 
Night Time 
 
 
 
 
 
 
 
 
 
 
xxx 
xxxxxxx 
xxxxxxxxx/ 
xxxxxxxxx/ 
xxxxxxxxx 
ddmmyyyy 
xx.x (Unit+) 
x 
x 
x 
 
 
 
 
 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for programmer: 
Don’t show the following symbol in the listing. They are specified for a better programming understanding. 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 80 of 96 
+Unit can be “mg”, “mcg”, “g”, “mL”, “Tab”, “IU”, “Capsule”, “Puff”, if answer to "Unit" is “Other” include the text 
specified 
 
13.2.8 Layout L7 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
  
 
Subject 
ID 
Randomized 
Treatment 
Active treatment 
Treatment---------------------------
---- 
    Start             End 
Treatment 
duration 
(days) 
 
 
 
 
 
 
 
xxx 
xxxxxxx 
xxxxxxx 
ddmmyyyy 
ddmmyyyy 
 
xx 
 
 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
 
13.2.9 Layout L8 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subject ID 
Randomized 
Treatment 
Total number of 
doses taken 
Compliance(%) 
Category 
Special situation 
 
Category 
 
 
 
 
 
xxx 
xxx 
xxx 
xxxxx 
No/Yes: 
 
xxxxxxx 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.2.10Layout L9 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subject ID 
Randomized 
Treatment 
Treatment 
     Start            End             Day 
Study completed 
 
Reason 
 
 
 
 
 
 
 
xxx 
xxx 
ddmmyyyy 
ddmmyyyy 
xx 
Yes/No: 
 
xxxxx 
 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.2.11Layout L10 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subject 
ID 
Active 
Treatment 
System organ 
class/ 
Preferred 
term/ 
Reported term 
Start 
date/ 
Time/
Study 
Day* 
End 
date/ 
Time/ 
Duration 
(days) 
Treatment 
Emergent** 
Serious 
Severity 
Relation. 
to study 
drug 
Action 
Taken 
With Study 
drug 
Outcome 
 
 
 
 
 
 
 
 
 
 
 
xxx 
xxx 
xxxxxxx/ 
xxxxxxxx/ 
xxxxxxx 
ddmmy
yyy/ 
Hh:mm 
ddmmyyyy
/ 
Hh:mm 
Yes/No 
No/Yes: 
xxxxx 
xxxxx 
xxxxx 
 
xxxxx 
xxxxx 
 
 
 
 
 
 
 
 
 
 
 
*Study day is the day of the event relative to the treatment start date. 
**Treatment-emergent adverse event is any event with onset date/time between the study treatment start date and the study 
treatment end date, limits included. 
System Organ Class and Preferred terms are based on MedDRA 25.1 dictionary. 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 81 of 96 
Note for Programmer: Severity = Intensity of AE.  
13.2.12Layout L11 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subject 
ID 
Active 
Treatment 
Visit 
Parametr 
(unit) 
Assessment 
date/time 
Study day 
Result  
Change 
from 
baseline 
Report 
any 
clinica
lly 
signifi
cant 
finding
s 
during 
the 
vital 
signs 
assessm
ent 
 
 
 
 
 
 
 
 
 
xxx 
xxx 
xxxxxxx 
Xxxxxxxx (xx) 
ddmmyyyy/ 
Hh:mm 
xx 
xx.x 
xx.x 
xxxxxxx 
 
 
 
 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.2.13Layout L12 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subject 
ID / 
Active 
Treatmen
t 
Visi
t 
Paramete
r (unit) 
 
 
Test 
Assessment 
date/time 
Stud
y 
Day 
Resul
t 
Change 
from 
Baselin
e 
Test 
performe
d 
Value category 
 
Valu
e 
 
 
 
 
 
 
 
 
 
 
 
xxx / 
xxxxx 
xxxx
x 
xxxxx 
(xx) 
 
Hematology 
| Chemistry 
| Urine 
ddmmyyyy/hh
:mm 
xx 
xx.x 
xx.x 
No/Yes 
 
Normal/Abnormal 
not clinically 
significant/Abnorm
al clinically 
significant 
 
xx.x 
 
 
 
 
 
 
 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
13.2.14Layout L13 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subject ID 
Active 
Treatment 
Visit 
Pregnancy test performed 
 
Result* 
Serum pregnancy test 
performed as 
confirmation 
 
 
 
 
 
 
 
xxx 
xxxxx 
xxxxx 
No/Yes 
Negative/Positive 
Yes/No 
 
 
 
 
 
 
 
*If pregnancy test is positive, subject must be withdrawn from study  
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.2.15Layout L14 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subject ID 
Active 
Treatment 
Visit 
Physical examination 
And 
Blood pressure 
Physical examination finding 
(clinically significant) 
 
 
 
 
 
 
 
xxx 
xxxxxxx 
xxxxxxx 
Body Weight (kg) 
xx.x 
General appearance 
Yes/No 
 
 
 
Height (cm) 
xx.x 
Skin 
Yes/No 
 
 
 
BMI (kg/m2) 
xx.x 
Head / neck / thyroid 
Yes/No 
 
 
 
Temperature (C°) 
xx.x 
Lymph nodes 
Yes/No 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 82 of 96 
 
 
 
Respiratory Rate 
(Breaths/minute) 
xx.x 
Musculosceletal system 
Yes/No 
 
 
 
Systolic (mmHg) 
xx.x 
Cardiovascular system 
Yes/No 
 
 
 
Diastolic (mmHg) 
xx.x 
Respiratory system 
Yes/No 
 
 
 
Heart rate (beats/min) 
xx.x 
Abdomen 
Yes/No 
 
 
 
 
 
Neurological system 
Yes/No 
 
 
 
 
 
Other(specify): 
 
 
 
 
 
 
xxxxxxx 
Yes/No 
 
 
 
 
 
xxxxxxx 
Yes/No 
 
 
 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note to Programmer: parameters in column 'Physical examination And Blood pressure' are reported for Baseline vivst only 
13.2.16Layout L15 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subjec
t ID 
Randomize
d 
Treatment 
Test 
performe
d 
 
Visi
t 
Date(Time) 
Stop 
signal 
task 
Discountin
g task 
Psychomoto
r 
Vigilance 
Task 
Time 
Productio
n Task 
Time 
Reproductio
n Task 
 
 
 
 
 
 
 
 
 
 
xxx 
xxxxxxx 
Yes/No 
xxx 
Ddmmyyyy(Time
) 
Done/No
t done 
Done/Not 
done 
Done/Not 
done 
Done/Not 
done 
Done/Not 
done 
 
 
 
 
 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.2.17Layout L16 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
 
Subje
ct ID 
Randomiz
ed 
Treatmen
t 
Date 
of 
comp
leti
on/ 
Time 
of 
comp
leti
on 
Time 
Expec
ted 
VAS 
questionna
ire 
completed 
by the 
subject 
 
VAS (mm) 
Any 
drug 
effe
ct  
Good 
drug 
effe
ct 
Bad 
drug 
effe
ct 
Drug 
liki
ng 
Fea
r 
Naus
ea 
Alterat
ion of 
vision 
Alterat
ion of 
sense 
of time 
The 
boundarie
s between 
myself 
and my 
surroundi
ngs seem 
to blur 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xxx 
xxxxxx 
ddmm
yyyy
/ 
hh:m
m 
0/ 
0.5/ 
1/ 2/ 
3/ 4/ 
6 
No/Yes 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.2.18 Layout L17 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subje
ct ID 
Randomized 
Treatment 
 
Date of 
ADHD 
diagnosis 
Attention deficit 
(hyperactivity) 
disorder confirmed 
ADHD 
medication 
 
Name of 
medication/ 
Indication/ 
Total daily 
dose(Unit)/ 
Amount taken 
in the 
morning/ 
Amount taken 
in the 
afternoon/ 
Amount taken 
in the night 
Alcohol, caffeine, 
nicotine 
Substance use 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 83 of 96 
time/ Date of 
last dose 
 
 
 
 
 
 
 
 
 
 
xxx 
xxxxx 
ddmmyyyy 
Criteria 
according 
to DSMV 
 
All 
Criteria 
Met/No 
Met 
No/Yes: xxxxx 
/ xxxxx /xx.x 
(Unit)/ 
xxxxx/ xxxxx/ 
xxxxx/ 
ddmmyyyy 
Current 
smoker 
No/Yes( 
Cigarette
s per 
day: xx/ 
Packs per 
year: xx) 
MDMA/Ecs
tasy 
No/Yes(To
tal 
lifetime 
use: 
xx.x/ 
Last use: 
ddmmyyyy) 
 
 
 
Complete 
CAARS-S-OR 
screening 
 
No/Yes(A
/B/C/D) 
 
Coffee 
No/Yes(Pe
r day xx) 
Sedative
, 
Narcotic 
(Benzos, 
Ketamine
, 
Laughing 
gas 
(nitrous 
oxide)) 
No/Yes(To
tal 
lifetime 
use: 
xx.x/ 
Last use: 
ddmmyyyy) 
 
 
 
Current 
somatic 
disorder 
 
No/Yes 
 
Alcohol 
(Beer, 
wine, 
liquor 
etc. 
(standa
rd 
drink)) 
No/Yes(Pe
r week 
xx) 
Hallucin
ogenic 
(LSD, 
Mescalin
e, 
Psilocyb
in) 
No/Yes(To
tal 
lifetime 
use: 
xx.x/ 
Last use: 
ddmmyyyy) 
 
 
 
Previous 
hospitalisa
tion(s), 
previous 
disorders, 
(somatic 
and 
psychiatric
), previous 
surgery(s) 
 
No/Yes 
 
 
 
Stimulan
ts 
(Ampheta
mine, 
Cocaine, 
Methylph
enidate 
(recreat
ionally)
) 
No/Yes(To
tal 
lifetime 
use: 
xx.x/ 
Last use: 
ddmmyyyy) 
 
 
 
Family 
History 
(psychiatri
c and 
somatic) 
Yes/No 
 
 
 
Opioids 
(Morphin
e, 
Diacetyl
morphin, 
Codeine, 
Methadon
e) 
No/Yes(To
tal 
lifetime 
use: 
xx.x/ 
Last use: 
ddmmyyyy) 
 
 
 
 
 
 
 
 
Cannabis
, 
Marijuan
a, CBD 
No/Yes(To
tal 
lifetime 
use: 
xx.x/ 
Last use: 
ddmmyyyy) 
 
 
 
 
 
 
 
 
Others: 
(GHB, 
PCP, 
DXM, 
Spice) 
No/Yes(To
tal 
lifetime 
use: 
xx.x/ 
Last use: 
ddmmyyyy) 
 
 
 
 
 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for Programmer: CAARS-S-OR scores A,B,C,D correspond to: A-Score=DSM-IV Inattentive Symptoms; B-Score=DSM-IV 
Hyperactive/Impulsive Symptoms; C-Score=DSM-IV ADHD Symptoms Total; D-Score=ADHD Index on the screening 'ADHD Medical 
History' eCRF form. 
13.2.19Layout L18 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subject 
ID 
Randomized 
Treatment 
Visit 
Date of 
completion/ 
Time of 
completion 
Study day 
AISRS 
completed by 
investigator 
Score 
 
Adult ADHD investigator 
symptom rating scale (AISRS) 
 
 
 
 
 
 
 
 
 
xxx 
xxxxxxx 
 
xx.x/ 
ddmmyyyy/ 
hh:mm  
 
No/Yes 
xx.x 
 
Do you make 
careless 
mistakes when 
working on a 
boring or 
difficult 
project? 
0 None/ 
1 Mild/ 
2 Moderate/ 
3 Severe 
 
 
 
 
 
 
 
Do you fidget 
or squirm 
with your 
0 None/ 
1 Mild/ 
2 Moderate/ 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 84 of 96 
hands or feet 
when you have 
to sit down 
for a long 
time?  
3 Severe 
 
 
 
 
 
 
 
Do you have 
difficulty 
keeping your 
attention 
when you are 
doing boring 
or repetitive 
work?  
0 None/ 
1 Mild/ 
2 Moderate/ 
3 Severe 
 
 
 
 
 
 
 
Do you leave 
your seat in 
meetings or 
other 
situations in 
which you are 
expected to 
remain 
seated?  
0 None/ 
1 Mild/ 
2 Moderate/ 
3 Severe 
 
 
 
 
 
 
 
Do you have 
difficulty 
concentrating 
on what 
people say to 
you, even 
when they are 
speaking to 
you directly? 
0 None/ 
1 Mild/ 
2 Moderate/ 
3 Severe 
 
 
 
 
 
 
 
Do you feel 
restless or 
fidgety? 
0 None/ 
1 Mild/ 
2 Moderate/ 
3 Severe 
 
 
 
 
 
 
 
Do you have 
trouble 
wrapping up 
the final 
details of a 
project, once 
the 
challenging 
parts 
have been 
done? 
0 None/ 
1 Mild/ 
2 Moderate/ 
3 Severe 
 
 
 
 
 
 
 
Do you have 
difficulty 
unwinding and 
relaxing when 
you have time 
to yourself? 
0 None/ 
1 Mild/ 
2 Moderate/ 
3 Severe 
 
 
 
 
 
 
 
Do you feel 
overly active 
and compelled 
to do things, 
like you were 
driven by a 
motor? 
0 None/ 
1 Mild/ 
2 Moderate/ 
3 Severe 
 
 
 
 
 
 
 
Do you avoid 
or delay 
getting 
started on a 
task that 
requires a 
lot of 
thought? 
0 None/ 
1 Mild/ 
2 Moderate/ 
3 Severe 
 
 
 
 
 
 
 
Do you find 
yourself 
talking too 
much when you 
are in social 
situations? 
0 None/ 
1 Mild/ 
2 Moderate/ 
3 Severe 
 
 
 
 
 
 
 
Do you 
misplace or 
have 
difficulty 
finding 
things at 
home or at 
work? 
0 None/ 
1 Mild/ 
2 Moderate/ 
3 Severe 
 
 
 
 
 
 
 
When you're 
in a 
conversation, 
do you find 
yourself 
finishing the 
sentences of 
the people 
you that 
talking to, 
before they 
can finish 
them 
themselves? 
0 None/ 
1 Mild/ 
2 Moderate/ 
3 Severe 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 85 of 96 
 
 
 
 
 
 
 
Do you find 
yourself 
being 
distracted by 
activity or 
noise around 
you? 
0 None/ 
1 Mild/ 
2 Moderate/ 
3 Severe 
 
 
 
 
 
 
 
Do you have 
difficulty 
waiting your 
turn in 
situations 
when turn 
taking is 
required? 
0 None/ 
1 Mild/ 
2 Moderate/ 
3 Severe 
 
 
 
 
 
 
 
Do your have 
problems 
remembering 
appointments 
or 
obligations? 
0 None/ 
1 Mild/ 
2 Moderate/ 
3 Severe 
 
 
 
 
 
 
 
Do you 
interrupt 
others when 
they are 
busy? 
0 None/ 
1 Mild/ 
2 Moderate/ 
3 Severe 
 
 
 
 
 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.2.20Layout L19 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subject 
ID 
Randomized 
Treatment 
Date of 
completion/ 
Time of 
completion 
 
CGI-S completed by 
investigator 
 
 
Considering your total clinical experience with this 
particular population, how mentally ill is the 
subject at this time? 
 
 
 
 
 
xxx 
xxxxxxx 
ddmmyyyy/ 
hh:mm 
No/Yes: 
 
 
 
1. Normal, not at all ill/ 
2. Borderline mentally ill/ 
3. Mildly ill/ 
4. Moderately ill/ 
5. Markedly ill/ 
6. Severely ill/ 
7. Among the most extreme ill subjects 
 
 
 
 
 
Clinical Global Impression - Severity of Illness Scale (CGI-S) 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.2.21Layout L20 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subject ID 
Randomized 
Treatment 
Date of completion/ 
Time of completion 
ASRS completed by 
subject 
 
 
Score/ 
 
 
 
 
 
 
xxx 
xxxxxxx 
ddmmyyyy/ 
hh:mm 
No/Yes: 
xx.x 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.2.22 Layout L21 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subject ID 
Randomized 
Treatment 
Date of completion/ 
Time of completion 
 
CAARS completed by the 
subject 
 
Score 
 
 
 
 
 
 
xxx 
xxxxxxx 
ddmmyyyy/ 
hh:mm  
 
No/Yes 
 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 86 of 96 
 A:xx/B:xx /C:xx /D:xx 
/E:xx /F:xx /G:xx 
/H:xx 
 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for Programmer: <A/B/C/D/E/F/G/H> refer to scores on 'Patient Reported Outcomes' eCRF page. In the listing scores 
<A/B/C/D/E/F/G/H> should be reported as: A=Inattention/Memory Problems; B=Hyperactivity/Restlessness; 
C=Impulsivity/Emotional Lability; D=Problems with Self-Concept; E=DSM-IV Inattentive Symptoms; F=DSM-IV Hyperactive-
Impulsive Symptoms; G=DSM-IV ADHD Symptoms Total; H=ADHD Index. 
13.2.23 Layout L22 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subject ID 
Randomized 
Treatment 
Date of completion/ 
Time of completion 
 
5D-ASC completed by 
the subject 
 
If yes: 
 
 
 
 
 
xxx 
xxxxxxx 
ddmmyyyy/ 
hh:mm 
 
No/Yes 
 
 
1.Oceanic 
boundlessness: xx 
2.Anxious ego 
dissolution: xx 
3.Visionary 
destructuralization: 
xx 
4.Auditory 
alterations: xx 
5.Vigilance reduction: 
xx 
Total score: xx 
 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.2.24 Layout L23 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subject ID 
Randomized 
Treatment 
Date of completion/ 
Time of completion 
MEQ completed by the 
subject 
 
If yes; 
 
 
 
 
 
xxx 
xxxxxx 
ddmmyyyy/ 
hh:mm  
 
No/Yes: 
 
Transcendence: xx.x% 
Positive mood: xx.x% 
Ineffability: xx.x% 
Mystical: xx.x% 
Total score: xx.x% 
 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.2.25Layout L24 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subject ID 
Active 
Treatment 
Date of death 
Study Day of 
death* 
Treatment 
Emergent** 
Cause of death 
(Preferred 
term) 
 
 
 
 
 
 
xxx 
xxxxxx 
ddmmyyyy 
xx 
Yes/No 
xxxxxxxx 
 
 
 
 
 
 
*Study day is the day of death relative to the treatment start date. 
**Treatment-emergent date/time of death occured between the study treatment start date and the study treatment end date, 
limits included. 
Preferred terms are based on MedDRA 25.1 dictionary. 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 87 of 96 
13.2.26Layout L25 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subject 
ID 
Active 
Treatment 
Visit 
Parameter 
(unit) 
Assessment 
date/time 
Day 
Result 
Change 
from 
Baseline 
Abnormalities 
found 
 
Abnormalities 
Explanation 
 
 
 
 
 
 
 
 
 
 
xxx 
xxxxxx 
xxxxxx 
xxxxxx 
(xx) 
ddmmyyyy/ 
hh:mm 
xx 
xx.x 
xx.x 
No/Yes 
xxxxxxxxx 
 
 
 
 
 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.2.27Layout L26 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subject 
ID 
Sex 
Age 
(years) 
Visit  
 
Assessment 
date/time   
Planned 
Time Point 
MM-120 plasma 
concentration 
(ng/ml) 
Systolic 
(mmHg) 
Diastolic 
(mmHg) 
Heart 
rate 
(bpm]) 
Other 
Information 
 
 
 
 
 
 
 
 
 
 
 
xxx 
xx 
xx 
Week 1 
Day 1 
ddmmyyyy 
 
 
 
 
 
 
 
 
 
hh:mm  
pre-dose 
xx.x 
xx.x 
xx.x 
xx.x 
xxxxxx 
 
 
 
 
hh:mm  
after dose 
xx.x 
xx.x 
xx.x 
xx.x 
xxxxxx 
 
 
 
 
hh:mm  
after dose 
xx.x 
xx.x 
xx.x 
xx.x 
xxxxxx 
 
 
 
 
… 
… 
… 
… 
… 
… 
… 
Lower Limit of Quantitation = xx.x; Upper Limit of Quantitation = xx.x. 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for programmer: Other Information: fill in with free text if it is available in the provided data, if not ignore and 
do not report this column in the table. 
13.2.28Layout L27 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subject ID 
Sex 
Age(years) 
Parameter (unit) 
Value 
 
 
 
 
 
xxx 
xx 
xx 
xxxxxx (xx) 
xx.x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
13.2.29 Layout L28 
Study MMED007 – Deliverables: <Deliverables> 
Listing <Number of listing> 
<Title> 
Analysis set: <analysis set> 
Subj
ect 
ID 
Acti
ve 
Trea
tmen
t 
Was 
the C-
SSRS 
comple
ted 
 by 
the 
invest
igator
? 
Visi
t  
 
Date/ 
time of 
complet
ion   
Suicidal 
ideation  
since last 
visit 
(SLV) 
Descript
ion if 
Yes for 
Suicidal 
ideation 
SLV 
Intensity 
of 
ideation  
since last 
visit 
Descriptio
n of 
intensity 
of 
ideation 
SLV 
Suicidal 
behavior 
since 
last 
visit 
Descripti
on of 
suicidal 
behavior 
SLV 
Answer 
for 
actual 
attempts 
only 
 
 
 
 
 
 
 
 
 
 
 
 
xxx 
xxx 
Yes/No 
Base
line 
… 
ddmmyyy
y/ 
hh:mm 
 
1. Wish to 
be dead? 
[Yes | No] 
 
… 
 
 
1. xxxxx 
 
 
 
… 
 
 
Most 
severe 
ideation   
 
… 
 
 
[1 | 2 | 3 
| 4 | 5] + 
descriptio
n 
 
… 
 
 
Actual 
Attempt/ 
[Yes | 
No] 
 
… 
 
 
Total 
number of 
attempts 
| NA 
 
 
… 
Most 
lethal 
attempt 
date / 
dd.mm.yyy
y 
 
Actual 
lethality 
/ Medical 
damage /  


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 88 of 96 
[0 | 1 | 
2 | 3 | 4 
| 5] 
 
Potential 
Lethality 
/ [0 | 1 
| 2] 
 
| NA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NA = Not available 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for programmer:  
Visits: Baseline, Week 2 D8, Week 2 D12, Week 3 D15, Week 3 D19, Week 4 D22, Week 4 D26, Week 5 D29, Week 5 D33, Week 6 
D36, Week 6 D40, Week 10 Follow-up/Final visit for withdrawals 
Suicidal ideation  since last visit (SLV) / Description if Yes for Suicidal ideation SLV 
1. 
Wish to be dead? [Yes | No] / Description 
2. 
Non-specific active suicidal thoughts [Yes | No] / Description 
3. 
Active suicidal ideation with any methods (not plan) without intent to act [Yes | No] / Description 
4. 
Active suicidal ideation with some intent to act, without specific plan [Yes | No] / Description 
5. 
Active Suicidal Ideation with Specific Plan and Intent [Yes | No] / Description 
Intensity of ideation  since last visit / Description of intensity of ideation SLV 
• 
Most severe ideation  / [1 | 2 | 3 | 4 | 5] + Description  
• 
Frequency / [Less than once a week | Once a week | 2-5 times in a week | Daily or almost daily | Many times each 
day] 
• 
Duration / [Fleeting - few seconds or minutes | Less than 1 hour / some of the time | 1-4 hours / a lot of time | 
4-8 hours / most of the day | More than 8 hours / persistent or continuous] 
• 
Controllability / [Easily able to control thoughts | Can control thoughts with little difficulty | Can control 
thoughts with some difficulty | Can control thoughts with a lot of difficulty | Unable to control thoughts | Does 
not attempt to control thoughts] 
• 
Deterrents / [Deterrents definitely stopped you from attempting suicide | Deterrents probably stopped you | 
Uncertain that deterrents stopped you | Deterrents most likely did not stop you | Deterrents definitely did not 
stop you | Does not apply] 
• 
Reasons for ideation / [Completely to get attention | Mostly to get attention | Equally to get attention, revenge 
or a reaction from others and to end / stop the pain | Mostly to end or stop the pain (you couldn't go on living 
with the pain or how you were feeling) | Completely to end or stop the pain (you couldn't go on living with the 
pain or how you were feeling) | Does not apply] 
Suicidal behavior since last visit / Description of suicidal behavior SLV 
• 
Actual Attempt [Yes | No] / Total number of attempts 
• 
Or did you do it purely for other reasons / without ANY intention of killing yourself (like to relieve stress, 
feel better, get sympathy, or get something else to happen)? [Yes | No] / Description 
• 
Has subject engaged in Non-Suicidal Self-Injurious Behaviour? [Yes | No] / -- 
• 
Interrupted Attempt [Yes | No] /Total number of interrupted attempts + Description 
• 
Aborted Attempt [Yes | No] / Total number of interrupted attempts + Description 
• 
Preparatory Acts or Behavior [Yes | No] / Description 
• 
Suicidal behavior was present during the assessment period? [Yes | No] / -- 
• 
Suicide [Yes | No] / -- 
 
If there are no data to report, e.g. no patients with suicide attempts, please put in those columns 'NA'. For example in 
last three columns, 'Description of suicidal behavior SLV', 'Answer for actual attempts only'. 
 
 
 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 89 of 96 
13.3 FIGURE LAYOUTS 
13.3.1 Figure F1 
Study MMED007 – Deliverables: <Deliverables> 
Figure <Number of figure> 
<Title> 
Analysis set: <analysis set> 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for Programmer: Please use this template both for all PK profiles on same plot and for individual 
PK profiles (for each patient) on separate plots 
13.3.2 Figure F2 
Study MMED007 – Deliverables: <Deliverables> 
Figure <Number of figure> 
<Title> 
Analysis set: <analysis set> 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 90 of 96 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 
Note for Programmer: Please use this template both for all PK profiles on same plot and for individual 
PK profiles (for each patient) on separate plots 
13.3.3 Figure F3 
Study MMED007 – Deliverables: <Deliverables> 
Figure <Number of figure> 
<Title> 
Analysis set: <analysis set> 
 
MM-120 
Placebo 
 
 
The scale is expressed in percentages 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 91 of 96 
Note for programmer: Change Area text in “Oceanic boundlessness”, “Anxious ego dissolution”, “Visionary 
destructuralization”, “Auditory alterations”, “Vigilance reduction”. The baseline on the plot should be substituted 
by the Week 1 Day 1 
Change legend including treatment (Not Visit that is already shown above the graph) 
13.3.4 Figure F4 
Study MMED007 – Deliverables: <Deliverables> 
Figure <Number of figure> 
<Title> 
Analysis set: <analysis set> 
< Week 1 Day 1 /Week 6> 
 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 
Page x of x 
13.3.5 Figure F5 
Study MMED007 – Deliverables: <Deliverables> 
Figure <Number of figure> 
<Title> 
Analysis set: <analysis set> 
<Baseline> 
 
Program: program_name.sas, Produced on yyyy-mm-dd hh:mm (CET),  
Snapshot date: yyyy-mm-dd, Draft/final 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 92 of 96 
Page x of x 
Note for Programmer: Component=Factor 
 
 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 93 of 96 
APPENDIX B – DOCUMENT HISTORY 
Table 9. Version History 
Version 
Effective Date 
Reason 
Final 1.0 
31.03.2023 
First Final Version 
Final 2.0 
19.12.2023 
Implementation of the CSR. The 
following updates took place since the 
version 1.0: 
1)Visit windows -  if more than one value 
falls on the same day then the last 
sequential number in sdtm will be used; 
2)Visit windows - for parameters, where 
Time Interval Upper Limit for Baseline 
is equal to 1, please apply a rule of time 
defined in section 11.1.1.8 for Baseline; 
3)Visit windows - updatedupper and 
lower limits for time intervals; 
4)Visit windows - added visit windows 
for 
 
AISRS, 
CGI 
and  
Pharmacodynamics endpoints. 
5)Study databases - final list with 
concomitant 
prohibited 
medications, 
including flags for intake or change in 
prohibited 
concomitant 
medications/therapies 
which 
have 
potential confounding effects will be 
provided by the Sponsor; 
6)Safety endpoints - treatment-emergent 
MLAs definition added; 
7)Abnormal laboratory values -  Red 
Bloodcell count (RBC) in pl should be 
used in all summaries and listings; 
8)Vital signs -  in case of missing time of 
the Vital Signs assessment on the date of 
fisrt dosing, time 00:00 will be  imputed 
on the corresponding date; 
9)Columbia-Suicide 
Severity 
Rating 
Scale definition was added; 
10)Primary efficacy endpoint analysis 
(handling the IEs) -  intake or change in 
concomitant 
medications/therapies 
which 
have 
potential 
confounding 
effects will be treated as prohibited 
medications in the analyses as have the 
same definition. 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 94 of 96 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
11)Primary efficacy endpoint analysis 
(handling the IEs) - definition of 
intercurrent events (IEs) is added; 
12)Primary efficacy endpoint analysis - 
all assessments that took place after the 
IEs related to COVID-19 pandemic will 
be kept in the database; 
13)Primary efficacy endpoint analysis - 
in the evaluation of the primary endpoint 
will be included only subjects with NON 
missing baseline assessments; 
14)Dimensions of Altered States of 
Consciousness scale - baseline is not 
available for this endpoint, thus was 
substituted by the  Week 1 Day 1;  mean 
instead of median of the scores in 5 
dimensions will be displayed on the 
spider plot as  quite all the medians are 
zero; 
15)Adverse events analysis -  added 
clarification: the summary tables will be 
presented in descending order according 
to the incidence in the 'All' group (e.g., 
SOC and PT within each SOC with the 
highest number of occurrences will 
appear 
first). 
Equal 
frequency 
of 
different SOC/PTs will be sorted in 
alphabetical order of the SOC/PT; 
16)Columbia-Suicide Severity Rating 
Scale analysis is added; 
17)Baseline definition is clarified - if the 
baseline visit takes place on the date of 
the first dose of investigational drug, 
then time should be considered, i.e. 
baseline date/time < first dose date/time; 
18)Handling of missing date and time 
fields is updated; 
19)Topline 
results 
endpoints 
were 
defined in section 12; 
20)Some update of shells; 
21)Text 
editings 
 
throughout 
the 
document.  


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 95 of 96 
APPENDIX C – PROHIBITED MEDICATIONS 
Drug Class or Drug Name 
Washout Conditions/ Prohibition 
Period a 
Allowable Conditions for use 
during study 
Benzodiazepines 
Last dose must have been taken at 
least 5 half-lives prior to Day -1 
/baseline 
To treat anxiety during 
study at Investigator’s 
discretion b 
Lithium 
Last dose must have been taken at 
least 7 days prior to Day -1 
/baseline 
None 
Monoamine oxidase inhibitors 
(MAOIs)c 
Last dose must have been taken at 
least 3 weeks prior to Day-1 
/baseline 
None 
Antipsychotics – traditional 
Antipsychotics – atypical Atypical 
agents (e.g., bupropion, 
mirtazapine) 
Barbiturates 
Selective serotonin reuptake 
inhibitors (SSRIs). For fluoxetine 
and its active metabolite, 
norfluoxetine, half-life (T1/2) of 
metabolite is more extended than 
other SSRIs and T1/2 of 7 to 15 
days should be allowed. 
Serotonin-norepinephrine reuptake 
inhibitors (SNRIs) 
Serotonin–norepinephrine– 
dopamine reuptake inhibitors 
(SNDRIs) 
Serotonin modulators (e.g., 
vortioxetine, trazodone) Tricyclic 
antidepressants (TCAs) Stimulants 
to treat AHD (e.g., 
methylphenidate hydrochloride, 
amphetamines) 
Non-stimulants to treat ADHD 
Last dose must have been taken at 
least 5 half-lives prior to Day - 
1/baseline 
None 
Other medications, e.g., efavirenz, 
supplements, herbal treatments, or 
therapeutics that affect serotonergic 
function (e.g., ginkgo biloba, St. 
John’s Wort, 5- hydroxytryptophan 
[5- HTP], ayahuasca, 
dimethyltryptamine [DMT], and 
opioids, in particular, tramadol, 
ketamine, dextromethorphan, 
meperidine, methadone, and other 
agents that 
inhibit the reuptake of serotonin) 
Last dose must have been taken at 
least 5 half-lives prior to Day - 
1/Baseline 
None 
a. Subjects on prohibited medications, supplements, or other therapeutics at the time of Screening may taper off that 
substance(s) prior to Day -1/Baseline (Visit 2) and will be eligible to participate in the study if the required washout 
conditions have been met. 
b. Benzodiazepines should only be offered and administered if non-pharmacological interventions (e.g., reassurance, verbal 
communication) do not adequately address severe anxiety symptoms. 
c. Although the half-life of MAOIs is typically 1.5-4 hours (eliminated quickly), the irreversible inhibition of monoamine 
oxidase may persist for 2-3 weeks due to the requirement for de novo synthesis of new enzyme, which is a relatively slow 
process. Therefore, washout for any MAOI should be conservatively 3 weeks. 
 
 


D-LYSERGIC ACID DIETHYLAMIDE (LSD) DTARTRATE (MM-120) 
Mind Medicine - Protocol MMED007 
Statistical Analysis Plan (SAP) Final 2.0, 19DEC2023                                                       Page 96 of 96 
APPENDIX D – CHANGES TO THE ANALYSES PLANNED IN THE STUDY 
PROTOCOL 
1. A summary of ADHD Medical History was provided in Section 8.3.  
2. The definition of the Screened analysis set missing in the Protocol, was added in section 
Error! Reference source not found. of the SAP to include data from subject screening f
ailures in analyses. 
3. For data completeness, the “Complete cases” sensitivity analysis on primary endpoint was 
added in  Section 10.7.3.3. 
4. Main analysis of the primary endpoint will be produced also on the PPS as a sensitivity 
analysis. 
5. The definition of the secondary pharmacokinetic objective missing in the Protocol, was 
provided in Section 7.2 of the SAP. 
6. The definition of the secondary pharmacodynamic objective missing in the Protocol, was 
provided in Section 7.2 of the SAP. 
7. The exploratory objective was modified as pharmacogenomic data analysis will not be 
covered in this SAP. 
8. Trial discontinuation analysis is adapted to the data provided in the “Termination Form”  
CRF section   (section 4.2.2 of the SAP) and is different from what is planned in the 
Protocol section 3.1. 
9. Factor analysis was added in this SAP (see Section 10.7.4) as an exploratory analysis aimed 
at understanding the relative contributions of individual AISRS items to overall observed 
efficacy.   
10. The pregnancy test results will be not analyzed at weeks 3, 5, and 6 as will be not recorded 
in the eCRF. All pregnancy test results are being recorded on the subject’s source document 
(paper record). See corresponding changes done in the footnote of the Table 2Table 1 in 
Section 2.1.2 
11. Categorical presentation of the Quality Sleep results was added with the exploratory purpose, see 
changes in Sections 8.10, 10.11 and 13.1.21.  
12. Intake or change in concomitant medications/therapies which have potential confounding effects 
will be treated as prohibited medications in the analyses as have the same definition.