Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000909325
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
8/07/2026
Date registered
Help: Date registered
23/07/2026
Date last updated
Help: Date last updated
28/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
23/07/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1, Open-label, Single-arm Basket Trial of Intravenously Administered Psilocin (TRP-8803) in Anorexia Nervosa, Fibromyalgia, Generalised Anxiety Disorder, Irritable Bowel Syndrome, Obsessive Compulsive Disorder, Post Traumatic Stress Disorder, and Treatment-resistant Major Depressive Disorder
Scientific title
A Phase 1, Open-label, Single-arm Basket Trial of Intravenously Administered Psilocin (TRP-8803) in Anorexia Nervosa, Fibromyalgia, Generalised Anxiety Disorder, Irritable Bowel Syndrome, Obsessive Compulsive Disorder, Post Traumatic Stress Disorder, and Treatment-resistant Major Depressive Disorder
Additional trial identifiers [1] 317209 0
TRYP-008
Universal Trial Number (UTN)
Trial acronym
BASKET-IV
Related trial records
The current study i) is a follow-up to ACTRN12624000547549; and ii) running in parallel to ACTRN12625000330448 and ACTRN12625000949482.

Health condition
Health condition(s) studied:
Anorexia Nervosa 341796 0
Fibromyalgia 341797 0
Generalized Anxiety Disorder 341798 0
Irritable Bowel Syndrome 341799 0
Obsessive Compulsive Disorder 341800 0
Post Traumatic Stress Disorder 341801 0
Treatment Resistant Major Depressive Disorder 341802 0
Condition category
Condition code
Mental Health 337871 337871 0 0
Anxiety
Mental Health 337872 337872 0 0
Depression
Mental Health 337873 337873 0 0
Eating disorders
Mental Health 337874 337874 0 0
Other mental health disorders
Oral and Gastrointestinal 338992 338992 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 338993 338993 0 0
Connective tissue diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This is a phase 1 open label uncontrolled trial of TRP-8803 (Psilocin) administered intravenously in conjunction with psychotherapy.

The study is a combined pharmacological and psychological treatment, and as such, each individual participant will receive psychotherapy before, during, and after each dosing session. All participants will be seen by the same two therapists from baseline through to the completion of the study. The trial therapists are qualified and experienced mental health professionals (i.e., psychiatrists, psychologists) with specialty training in empirically based therapeutic modalities and psychedelic-assisted psychotherapy. In every dyad, at least one therapist will be a medically qualified healthcare practitioner. This ensures appropriately qualified staff are able to administer trial medication, both the study drug and any medical interventions if required.

The psychotherapy focuses on three distinct phases of this approach: (1) Preparation: emphasising therapeutic alliance, non-avoidance training, psychological and practical preparation for dosing sessions, nature of and relationship to distress, anxiety management strategies, the importance of set and setting, and intention formation; (2) Dosing session: establishing suitable set and setting, and providing non-directive support when necessary; (3) Integration: focus on sustaining the change, emotion and body-focused therapy, meaning-centred integration into wider context, mindfulness training, ongoing peer- and professional support, and facilitating contextual changes to support outcomes. Therapy guides will ensure trial fidelity.

The intervention scheduled for all participants will commence with three preparatory psychotherapy sessions over a three-week period (weeks 1, 2, 3). One week later, participants will attend the first dosing session (week 4) in which the investigational medical product (IMP) will be administered in the first dosing session, followed by two sessions of integration psychotherapy; the first within 48 hours after the dosing session (week 4) and the second a week later (week 5). Participants will attend a second dosing session (week 6) to receive the IMP, followed by three sessions of integration psychotherapy, the first being with 48 hours of the dosing session, then once a week thereafter (weeks 6, 7, 8). All psychotherapy sessions will be scheduled for 90 minutes, however, sessions can be extended if required. Psychotherapy sessions will be primarily conducted face-to-face, however, online sessions (e.g., Microsoft Team or Zoom) can be organised under specific and approved circumstances (i.e., illness, distance). Treatment will be delivered to individual participants separately. Adherence to trial protocol (i.e., session attendance) will be documented.

TRP-8803 ADMINISTRATION:
On dosing days, TRP-8803 will be administered intravenously. The initial 5 mg loading dose infused over the first 20 minutes will provide a therapeutic dose of psilocin that will be maintained by infusing the maintenance dose of 5 mg over the following 120 minutes (total dose 10mg/140 minutes). Participants will be required to remain on site until they are cleared for safe discharge by the facilitating therapists, which may take upwards of 4 hours post infusion.
Intervention code [1] 333974 0
Treatment: Drugs
Intervention code [2] 333975 0
Treatment: Other
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 345327 0
The primary objective of the trial is to examine the safety and tolerability of a two-dose regimen of TRP-8803 administered in combination with psychotherapy (henceforth, TRP-8803 treatment).
Timepoint [1] 345327 0
i) During TRP-8803 dosing sessions via continuous therapists monitoring of participant physical and mental wellbeing for emergent AEs commencing prior to IMP administration until discharge. Blood pressure, HR, and ECG will be measured during IMP administration using an automated device and recorded in the source documentation at the following intervals: • Ninety minutes before dosing • Within 15 minutes, 30 minutes, and 45 minutes (± 10 minutes) after the start of the infusion • Within 1 hour (± 20 minutes) after the start of the infusion • Within 1.5 hours (± 20 minutes) after the start of the infusion • Within 2 hours (± 30 minutes) after the start of the infusion and every hour afterwards until the end of the session; ii) Through to 4 weeks following the second dosing session via a) scheduled post-dose psychotherapy, b) standardised self-reporting of side effects b1) within 24 hours of dosing, and b2) 7 days after dosing, c) medical examinations completed c1) within 24 hours of dosing, c2) at first integration psychotherapy session post dose, and c3) 4 weeks post dose 2, d) weekly online wellbeing monitoring checks commencing at baseline until the 4 week follow up visit e) 4 week post dose 2 follow up assessments, f) participant initiated contact with trial team, g) at any participant visit.
Secondary outcome [1] 461301 0
To examine the medium-term safety of TRP-8803 treatment.
Timepoint [1] 461301 0
From 4 weeks following the second dosing session until the 12 week follow up visit via a) weekly online wellbeing monitoring checks from the four week follow up visit until the 12 week follow up visit; b) 12 week follow up visits assessments including medical examination; c) participant initiated contact with trial team.
Secondary outcome [2] 461386 0
To characterise the intensity of the acute psychedelic experience of TRP-8803.
Timepoint [2] 461386 0
10, 20, and 40 minutes after the start of the infusion and then every 40 minutes until discharge, for both Dose 1 and Dose 2.
Secondary outcome [3] 461387 0
To characterise the quality of the acute psychedelic experience of TRP-8803.
Timepoint [3] 461387 0
Within 48 hours of Dose 1 and Dose 2.
Secondary outcome [4] 461388 0
To characterise the quality of the acute mystical experience of TRP-8803.
Timepoint [4] 461388 0
Within 48 hours of Dose 1 and Dose 2.
Secondary outcome [5] 461389 0
To characterise the psychedelic insight felt by participants during the acute psychedelic experience of TRP-8803.
Timepoint [5] 461389 0
Within 48 hours of Dose 1 and Dose 2.
Secondary outcome [6] 461390 0
To explore the acute and enduring effects of TRP-8803 on comprehensive electrophysiological markers of brain activity.
Timepoint [6] 461390 0
Continuous EEG recording for the duration of Dose 1 and Dose 2.
Secondary outcome [7] 461391 0
To explore the acute and enduring effects of TRP-8803 on comprehensive electrophysiological markers of brain activity.
Timepoint [7] 461391 0
For 20 minutes at the baseline visit, for 20 minutes at the 4-week post dose 2 follow-up visit, for 20 minutes at the 12-week post dose 2 follow-up visit.
Secondary outcome [8] 464133 0
To characterise changes in the resting-state functional organisation of large-scale brain networks following TRP-8803 treatment
Timepoint [8] 464133 0
12-week post dose 2 follow-up visit
Secondary outcome [9] 464134 0
To characterise the effects of TRP-8803 treatment on cognitive flexibility.
Timepoint [9] 464134 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [10] 464138 0
To characterise the effects of TRP-8803 treatment on emotion regulation
Timepoint [10] 464138 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [11] 464140 0
To characterise the effects of TRP-8803 treatment on mindfulness.
Timepoint [11] 464140 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [12] 464142 0
To characterise the effects of TRP-8803 treatment on interoceptive awareness
Timepoint [12] 464142 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [13] 464146 0
To characterise the effects of TRP-8803 treatment on internalised shame.
Timepoint [13] 464146 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [14] 464147 0
To characterise preliminary changes in clinician-rated global changes in severity following TRP-8803 treatment
Timepoint [14] 464147 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [15] 464148 0
To characterise preliminary changes in participant-rated global improvement following TRP-8803 treatment
Timepoint [15] 464148 0
4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [16] 464152 0
To characterise the effects of TRP-8803 treatment on anxiety symptom severity.
Timepoint [16] 464152 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [17] 464154 0
To characterise the effects of TRP-8803 treatment on anxiety symptom severity
Timepoint [17] 464154 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [18] 464156 0
To characterise the effects of TRP-8803 treatment on quality of life.
Timepoint [18] 464156 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [19] 464158 0
To characterise the effects of TRP-8803 treatment on satisfaction with life.
Timepoint [19] 464158 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [20] 464160 0
(Anorexia Nervosa Only) To characterise preliminary changes in Anorexia Nervosa-specific clinical symptoms following TRP-8803 treatment.
Timepoint [20] 464160 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [21] 464164 0
(Anorexia Nervosa Only) To characterise preliminary changes in Anorexia Nervosa-specific clinical symptoms following TRP-8803 treatment.
Timepoint [21] 464164 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [22] 464166 0
(Fibromyalgia Only) To characterise preliminary changes in Fibromyalgia-specific clinical symptoms following TRP-8803 treatment.
Timepoint [22] 464166 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [23] 464168 0
(Fibromyalgia Only) To characterise preliminary changes in Fibromyalgia-specific clinical symptoms following TRP-8803 treatment.
Timepoint [23] 464168 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [24] 464170 0
(Generalised Anxiety Disorder Only) To characterise preliminary changes in Generalised Anxiety Disorder-specific clinical symptoms following TRP-8803 treatment.
Timepoint [24] 464170 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [25] 464172 0
(Generalised Anxiety Disorder Only) To characterise preliminary changes in Generalised Anxiety Disorder-specific clinical symptoms following TRP-8803 treatment.
Timepoint [25] 464172 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [26] 464174 0
(Irritable Bowel Syndrome Only) To characterise preliminary changes in Irritable Bowel Syndrome-specific clinical symptoms following TRP-8803 treatment.
Timepoint [26] 464174 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [27] 464175 0
(Irritable Bowel Syndrome Only) To characterise preliminary changes in Irritable Bowel Syndrome-specific clinical symptoms following TRP-8803 treatment.
Timepoint [27] 464175 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [28] 464178 0
(Obsessive Compulsive Disorder Only) To characterise preliminary changes in Obsessive Compulsive Disorder-specific clinical symptoms following TRP-8803 treatment.
Timepoint [28] 464178 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [29] 464179 0
(Obsessive Compulsive Disorder Only) To characterise preliminary changes in Obsessive Compulsive Disorder-specific clinical symptoms following TRP-8803 treatment.
Timepoint [29] 464179 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [30] 464180 0
(Post Traumatic Stress Disorder Only) To characterise preliminary changes in Post Traumatic Stress Disorder-specific clinical symptoms following TRP-8803 treatment.
Timepoint [30] 464180 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [31] 464181 0
(Post Traumatic Stress Disorder Only) To characterise preliminary changes in Post Traumatic Stress Disorder-specific clinical symptoms following TRP-8803 treatment.
Timepoint [31] 464181 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [32] 464182 0
(Treatment-resistant Major Depressive Disorder Only) To characterise preliminary changes in Treatment-resistant Major Depressive Disorder-specific clinical symptoms following TRP-8803 treatment.
Timepoint [32] 464182 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.
Secondary outcome [33] 464183 0
(Treatment-resistant Major Depressive Disorder Only) To characterise preliminary changes in Treatment-resistant Major Depressive Disorder-specific clinical symptoms following TRP-8803 treatment.
Timepoint [33] 464183 0
baseline, 4-week post dose 2 follow-up visit, 12-week post dose 2 follow-up visit.

Eligibility
Key inclusion criteria
Individuals must meet the following criteria to be considered eligible for study participation:
• Illness duration > 24 months.
• Has previously undertaken recognised first-line treatment(s) appropriate to the participant’s indication under study.
• If concurrent treatment, agree to maintain the current treatment regimen during the trial unless a change is clinically required.
• Aged 18 to 60 years (inclusive) at the time of completing Stage 1 online screening.
• Voluntary consent to participate in the study and to undergo all study procedures.
• Ability to receive intravenous (IV) medication (i.e., adequate venous access) and willingness to adhere to the study regimen.
• Medically stable, in the judgement of the Medical Officer
• Agree to follow the directions of the Medical Officer regarding the consumption of non-prescription and prescription medications and supplements.
• Willing and able to follow dosing day instructions provided by the facilitating therapists.
• Agree not to operate motor vehicles or heavy machinery for 24 hours following discharge after each dosing session.
• Agree to arrange transport assistance by a support person following each dosing session.
• Able to provide contact details of their primary care physician or medical practice, and provide consent for trial staff to contact them if necessary.
• Non-smokers.
• Agree not to use nicotine-containing products for duration of participation.
• No use of psychedelic drugs for at least 3 months prior to psilocin administration.
• Agree to refrain from psychedelic use (other than study drug) during the study. Psychedelics include, but are not limited to, psilocybin, lysergic acid diethylamide (LSD), methylenedioxymethamphetamine (MDMA), ibogaine, and ayahuasca. Any other suspected psychedelic use must be discussed with and approved by the Sponsor.
• Women of childbearing potential (WOCBP) in sexual relationships with men must agree to use two acceptable forms of contraception from 30 days prior to screening until 30 days after the final dose of study drug.
• WOCBP must agree to refrain from donating ova (eggs) for at least 30 days after the final dose of study drug.
• Men must agree to avoid impregnating women and refrain from sperm donation during treatment and for 90 days after the final dose of study drug, using acceptable contraception methods.
• Meet all additional indication-specific inclusion criteria.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
The following exclusion criteria apply to all individuals considered for study participation:
• Requirement to withhold, interrupt, or taper an effective standard of care solely to enable trial participation.
• Unstable standard of care regimen or clinical circumstances that, in the investigators’ judgement, would confound safety assessment or increase risk.
• Participant has a recent history of suicide attempt, defined as an active, interrupted, or aborted suicide attempt within the previous 12 months, or presents with current suicidal ideation indicating an unacceptable risk. Participants who report passive suicidal ideation only (e.g., wish to be dead, without plan or intent) may be considered to inclusion if deemed safe by the medical officer or lead psychiatrist.
• Current or history of psychosis symptoms or related conditions, including bipolar disorder.
• First-degree family history of bipolar disorder, or first- or second-degree family history of schizophrenia or schizoaffective disorder.
• History of alcohol use disorder within 12 months prior to screening or regular abuse of alcohol within the previous 12 months.
• History of substance use disorder (other than alcohol) within 12 months prior to screening or regular abuse of alcohol within the past 12 months.
• History of adverse effects from psilocybin or other psychedelics (e.g., severe headache or severe hypertension requiring medical treatment), based on self-report.
• History of Hallucinogen Persisting Perception Disorder (HPPD).
• Presence of any serious medical condition that, in the judgement of the medical officer or lead psychiatrist, may interfere with safe participation in the trial (e.g., cardiovascular, metabolic, neurological, respiratory, oncological, haematological disorders, epilepsy, or seizures).
• Under treatment for epilepsy.
• Cardiovascular conditions including: uncontrolled hypertension, angina, clinically significant ECG abnormalities, transient ischaemic attack (TIA) within the past 6 months, stroke or cerebrovascular disease, peripheral or pulmonary vascular disease (if symptomatic or with active claudication). Exclusion also applies to abnormal ECG parameters identified at screening or from medical history, including QTc greater than 450 ms for men and greater than 470 ms for women, PR interval greater than 220 ms, or QRS duration greater than 120 ms.
• Clinically concerning haematological, electrolyte, renal, or liver function test results at screening, including aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 2 x upper limit of normal (ULN), or total bilirubin = 1.5 x ULN. Individuals with certain abnormal values may participate if they received medical clearance from their medically qualified healthcare provider or the medical officer on a case-by-case basis.
• Insulin-dependent diabetes mellitus. Participants with non-insulin-dependent diabetes treated with oral hypoglycaemic agents will be excluded if they have a history of hypoglycaemia.
• Serious infection requiring hospitalisation within the previous 28 days prior to dosing.
• Women of childbearing potential who are pregnant, breastfeeding, or actively trying to conceive.
• Participation in another clinical study involving investigational treatment within 30 days or 5 half-lives (whichever is longer) prior to screening.
• Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at screening.
• Positive test result for illicit substances or drugs of abuse on the day of dosing, prior to session commencement.
• Unless pre-approved by the Medical Officer.
• Positive alcohol test on the day of dosing, prior to session commencement.
• Donation of blood or blood products greater than 500 mL within 30 days prior to screening.
• Participants may be excluded at the discretion of the investigators if, in their judgment, participation poses a safety risk, would compromise data integrity, or would interfere with the safe and effective delivery of the intervention. This includes, but is not limited to, the presence of unmanaged psychiatric conditions (e.g., personality disorders, cPTSD), significant adverse childhood experiences (e.g., trauma), or current psychosocial instability (e.g., inadequate social support, unstable housing, or exposure to domestic violence) that would impair therapeutic rapport or the participant’s ability to safely undergo the intervention. This determination will be based on eligibility review and may include consultation with the participant’s healthcare team if appropriate.
• Meet additional indication-specific exclusion criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2026
Actual
Date of last participant enrolment
Anticipated
1/09/2027
Actual
Date of last data collection
Anticipated
1/02/2028
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 321787 0
Commercial sector/Industry
Name [1] 321787 0
Tryptamine Therapeutics
Country [1] 321787 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Tryptamine Therapeutics
Address
Country
Australia
Secondary sponsor category [1] 324634 0
None
Name [1] 324634 0
Address [1] 324634 0
Country [1] 324634 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320331 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 320331 0
Ethics committee country [1] 320331 0
Australia
Date submitted for ethics approval [1] 320331 0
01/05/2026
Approval date [1] 320331 0
30/07/2026
Ethics approval number [1] 320331 0
143/26

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 150114 0
Prof Susan Rossell
Address 150114 0
Centre for Mental Health and Brain Sciences; Swinburne University of Technology; John Street, Hawthorn, VIC, 3122
Country 150114 0
Australia
Phone 150114 0
+61 3 9214 8173
Fax 150114 0
Email 150114 0
[email protected]
Contact person for public queries
Name 150115 0
Dr Sean Carruthers
Address 150115 0
Centre for Mental Health and Brain Sciences, Swinburne University of Technology, John Street, Hawthorn, VIC, 3122
Country 150115 0
Australia
Phone 150115 0
+61 3 9214 3354
Fax 150115 0
Email 150115 0
[email protected]
Contact person for scientific queries
Name 150116 0
Dr Sean Carruthers
Address 150116 0
Centre for Mental Health and Brain Sciences, Swinburne University of Technology, John Street, Hawthorn, VIC, 3122
Country 150116 0
Australia
Phone 150116 0
+61 3 9214 3354
Fax 150116 0
Email 150116 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
Following a 36-month embargo period after publication of the primary trial findings

To:
A finite period of: 15 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Data sharing request system: Figshare

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  [email protected]
Statistical analysis plan  [email protected]


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.