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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001274460
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
16/10/2025
Date registered
Help: Date registered
17/11/2025
Date last updated
Help: Date last updated
21/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
17/11/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1 Study Determining the Safety, Tolerability, and Pharmacokinetics of single and multiple ascending oral doses of RTR242 in healthy adult participants.
Updated from
A Phase 1 Study Determining the Safety, Tolerability, and Pharmacokinetics of RTR242 in Healthy Subjects  
Updated on 21/09/2026 1:58:20 PM
Scientific title
Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of RTR242 in Healthy Subjects.
Updated from
Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of RTR242 in Healthy Subjects  
Reason: addition of single ascending cohorts allowing dose escalation to 2400mg under fed or fasted conditions.
Updated on 21/09/2026 1:58:20 PM
Additional trial identifiers [1] 315542 0
RTR242-001
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Early-Onset Alzheimer’s Disease 339161 0
Condition category
Condition code
Neurological 335444 335444 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The study will be examining RTR242, an oral liquid solution. The study drug is a powder that will be dissolved in liquid (between 6.25 and 25ml, depending on the dose). The study drug will be administered with 240ml (approximately 1 cup) of water by each participant, under the supervision of site staff, who will perform checks of the mouth.

Participants who enrol in the single ascending dose (SAD) portion of the study will be enrolled in 1 of 7 SAD cohorts (8 participants per cohort; 6 receiving RTR242 and 2 participants receiving placebo).
- SAD Cohorts 1, 2, 4, 5, A and B will receive a single dose of RTR242 or placebo under fasted conditions.
- SAD Food Effect (FE) Cohort 3 will receive a single dose of RTR242 or placebo on Day 1 (under fasted conditions) and on Day 8 approximately 30 minutes after consuming a high fat meal (about 800-1000 calories, approximately 15% protein, 25% carbohydrates and 60% fat).
The doses planned for the SAD cohorts range from 50mg up to a maximum of 2400mg. Cohort 1 will receive 50mg of RTR242, with each sequential cohort's dose increasing up to 100% from the previous cohort, based on the outcomes/review of the safety data by the Safety Review Committee (SRC) (i.e. Cohort 1 will receive 50mg RTR242, Cohort 2 will receive up to 100mg RTR242, FE Cohort 3 will receive up to 200mg RTR242 in fed and fasted conditions, Cohort 4 will receive up to 400mg RTR242, Cohort 5 will receive up to 800mg RTR242). Cohort A will receive up to a 100% increase from the Cohort 5 dose in fed conditions. Cohort B will receive up to 2400mg RTR242 in fed or fasted condition.
The multiple ascending dose (MAD) part of the study may commence once the SRC has reviewed the data obtained from SAD Cohort 3 (Food Effect) fasted period. Participants who enrol in one of the SAD cohorts will not take part in the MAD part of the study.

Participants who enrol in the MAD portion of the study will be enrolled in 1 of 6 MAD cohorts.
Cohorts 6 and 7 (8 participants per cohort; 6 participants receiving RTR242 and 2 participants receiving placebo) will receive daily doses of RTR242 (up to a maximum of 800mg per day) or placebo under fasted conditions for 6 days. The starting dose of RTR242 to be tested in Cohort 6 will be the same dose that was tested in SAD Cohort 2.
Cohort 7 dose will be up to 100% increase from MAD Cohort 6.
Cohort 8 (8 participants; 6 participants receiving RTR242 and 2 participants receiving placebo) will receive twice daily doses of RTR242 under fed conditions for 6 days. Cohort 8 dose will be up to 100% increase in daily dose from Cohort 7.
Cohort 9, MAD Cohort A and MAD Cohort B will receive once daily or twice daily dosing under fed or fasted conditions, subject to SRC review and approval prior to initiation of each cohort. MAD Cohort B dose will not exceed 2400 mg daily. Cohort 9 dose will be up to 100% increase from Cohort 8 daily dose, not to exceed the highest daily dose in SAD (QD or BID based on SRC determination). MAD Cohort A dose will be up to 100% increase from MAD Cohort 9 daily dose (QD or BID); fed or fasted at SRC discretion. MAD Cohort B dose will be up to 50% increase from MAD Cohort A. Dose determined by SRC, not to exceed 2400 mg daily (QD or BID); fed or fasted at SRC discretion.
Cohort 10 (4 participants) will be dosed with RTR242 no higher than MAD Cohort B under fed or fasted conditions as determined by the SRC.
Updated from
The study will be examining RTR242, an oral liquid solution. The study drug is a powder that will be dissolved in liquid (between 6.25 and 25ml, depending on the dose). The study drug will be administered with 240ml (approximately 1 cup) of water by each participant, under the supervision of site staff, who will perform checks of the mouth. Participants who enrol in the single ascending dose (SAD) portion of the study will be enrolled in 1 of 5 SAD cohorts (8 participants per cohort; 6 receiving RTR242 and 2 participants receiving placebo). - SAD Cohorts 1, 2, 4 and 5 will receive a single dose of RTR242 or placebo under fasted conditions. - SAD Food Effect (FE) Cohort 3 will receive a single dose of RTR242 or placebo on Day 1 (under fasted conditions) and on Day 8 approximately 30 minutes after consuming a high fat meal (about 800-1000 calories, approximately 15% protein, 25% carbohydrates and 60% fat). The doses planned for the SAD cohorts range from 50mg up to a maximum of 800mg. Cohort 1 will receive 50mg of RTR242, with each sequential cohort's dose increasing up to 100% from the previous cohort, based on the outcomes/review of the safety data by the Safety Review Committee (SRC) (i.e. Cohort 1 will receive 50mg RTR242, Cohort 2 will receive up to 100mg RTR242, FE Cohort 3 will receive up to 200mg RTR242, etc.). The multiple ascending dose (MAD) part of the study may commence once the SRC has reviewed the data obtained from SAD Cohort 3 (Food Effect) fasted period. Participants who enrol in one of the SAD cohorts will not take part in the MAD part of the study. Participants who enrol in the MAD portion of the study will be enrolled in 1 of 5 MAD cohorts. - Cohorts 6, 7, 8 and 9 (8 participants per cohort; 6 participants receiving RTR242 and 2 participants receiving placebo) will receive daily doses of RTR242 (up to a maximum of 800mg per day) or placebo for 6 days. - Cohort 10 (4 participants) will receive up to 800mg of RTR242 daily for 6 days. The starting dose of RTR242 to be tested in Cohort 6 will be the same dose that was tested in SAD Cohort 2. The dose level to be tested in Cohort 7, 8 and 9 will increase up to 100% from the previous cohort, based on the outcomes/review of the safety data by the Safety Review Committee (i.e. if Cohort 6 receives 100mg RTR242, Cohort 7 will receive up to 200mg RTR242, Cohort 8 would receive up to 400mg RTR242, etc.). The dose level for Cohort 10 will be chosen following the review of all the MAD data. The maximum dose in the MAD part of the study will not exceed the maximum dose achieved in the SAD cohorts.  
Reason: - To add SAD cohort A, SAD cohort B, MAD cohort A and MAD cohort B - To increase the maximum dose of RTR242 from 800 to 2400mg SAD cohort B, MAD cohort A and MAD cohort B - The protocol update was implemented after the completion of SAD Cohort 5 and MAD Cohort 7, after 56 participants had been enrolled and treated.
Updated on 21/09/2026 1:58:20 PM
Intervention code [1] 332169 0
Treatment: Drugs
Description of the comparator or control
The placebo formulation that will be utilised contains calcium carbonate (masking agent), hydroxypropyl methylcellulose E15, xanthan gum, strawberry flavour, sodium benzoate, sucralose, and butylated hydroxytoluene.

The placebo is an oral suspension (between 6.25 and 25ml, depending on the dose) that will be administered with 240ml (approximately 1 cup) of water.
Updated from
The placebo formulation that will be utilised in Cohorts 1-9 contains calcium carbonate (masking agent), hydroxypropyl methylcellulose E15, xanthan gum, strawberry flavour, sodium benzoate, sucralose, and butylated hydroxytoluene. The placebo is an oral suspension (between 6.25 and 25ml, depending on the dose) that will be administered with 240ml (approximately 1 cup) of water.  
Reason: Generalisation of what cohorts the placebo will be used for, as it is used across all cohorts
Updated on 21/09/2026 1:58:20 PM
Control group
Placebo

Outcomes
Primary outcome [1] 343009 0
To evaluate the safety and tolerability of RTR242 following single ascending doses (SAD) in healthy adult subjects
Timepoint [1] 343009 0
1. Treatment emergent AEs (TEAEs) will be collected up until 28 days following the End of Study (EOS)/Early Termination (ET) Visit (7 days post dose) 2. - Physical examination to be conducted at screening, Day -1, 3 and 8 (EOS/ET) post dose for participants in Cohorts 1, 2, 4, 5, A and B. Physical examination will be conducted at Screening, Day -1, 3, 7, 10 and 15 (EOS/ET) post first dose for participants in Cohort 3. Physical exams may also be performed as needed in between for all participants. - Vital signs collected at Screening, Day -1, 1, 2, 3 and 8 post dose (Cohorts 1, 2, 4, 5 A and B) and Screening, Day -1, 1, 2, 3, 7, 8, 9, 10 and 15 post first dose (Cohort 3). - Clinical laboratory tests at Screening, Day -1, 3 and 8 post dose (Cohorts 1, 2, 4, 5, A and B) and Screening, Day -1, 1, 3, 7, 10 and 15 post first dose (Cohort 3). - ECG collected at Screening, Day 1, 2, 3 and 8 post dose (Cohorts 1, 2, 4, 5 A and B), Screening, Day 1, 2, 3, 8, 9, 10 and 15 post first dose (Cohort 3).
Updated from
1. Treatment emergent AEs (TEAEs) will be collected up until 28 days following the End of Study(EOS)/Early Termination (ET) Visit (7 days post dose) 2. - Physical examination to be conducted at screening, Day -1, 3 and 8 (EOS/ET) post dose for participants in Cohorts 1, 2, 4 and 5. Physical examination will be conducted at Screening, Day -1, 3, 7, 10 and 15 (EOS/ET) post first dose for participants in Cohort 3. Physical exams may also be performed as needed in between for all participants. - Vital signs collected at Screening, Day -1, 1, 2, 3 and 8 post dose (Cohorts 1, 2, 4 and 5) and Screening, Day -1, 1, 2, 3, 7, 8, 9, 10 and 15 post first dose (Cohort 3). - Clinical laboratory tests at Screening, Day -1, 3 and 8 post dose (Cohorts 1, 2, 4 and 5) and Screening, Day -1, 1, 3, 7, 10 and 15 post first dose (Cohort 3). - ECG collected at Screening, Day 1, 2, 3 and 8 post dose (Cohorts 1, 2, 4 and 5), Screening, Day 1, 2, 3, 8, 9, 10 and 15 post first dose (Cohort 3).  
Reason: - Referencing SAD cohorts A and B and MAD Cohorts A and B -The protocol update was implemented after the completion of SAD Cohort 5 and MAD Cohort 7, after 56 participants had been enrolled and treated.
Updated on 21/09/2026 1:58:20 PM
Primary outcome [2] 343243 0
To evaluate the safety and tolerability of RTR242 following multiple ascending doses (MAD) in healthy adult subjects
Timepoint [2] 343243 0
1. Treatment emergent AEs (TEAEs) will be collected up until 28 days following the End of Study(EOS)/Early Termination (ET) Visit 2. - Physical examination conducted at screening, Day -1, 8 (discharge) and 14 (EOS/ET) post first dose. Physical examinations may be performed as needed in between. - Vital signs collected at Screening, Day -1, 1 to 8 and 14 post first dose. - Clinical laboratory tests at Screening, Day -1, 3, 8 and 14 post first dose. - ECG collected at Screening, Day -1, 1 to 8 and 14 post first dose.
Updated from
1. Treatment emergent AEs (TEAEs) will be collected up until 28 days following the End of Study(EOS)/Early Termination (ET) Visit 2. - Physical examination conducted at screening, Day -1, 8 (discharge) and 14 (EOS/ET) post first dose. Physical examinations may be performed as needed in between. - Vital signs collected at Screening, Day -1, 1 to 8 and 14 post first dose. - Clinical laboratory tests at Screening, Day -1, 8 and 14 post first dose. - ECG collected at Screening, Day -1, 1 to 8 and 14 post first dose.  
Reason: - The protocol update was implemented after the completion of SAD Cohort 5 and MAD Cohort 7, after 56 participants had been enrolled and treated
Updated on 21/09/2026 1:58:20 PM
Secondary outcome [1] 453123 0
To characterize the single-dose and multiple-dose pharmacokinetics (PK) of RTR242 under fasted and fed conditions.
Updated from
To characterize the single-dose and multiple-dose pharmacokinetics (PK) of RTR242 under fasted conditions  
Reason: - The protocol update was implemented after the completion of SAD Cohort 5 and MAD Cohort 7, after 56 participants had been enrolled and treated
Updated on 21/09/2026 1:58:20 PM
Timepoint [1] 453123 0
SAD Cohorts 1, 2, 4, 5 A and B: PK blood samples collected prior to study drug administration on Day 1 and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, and 48 hours, and at Day 8. MAD Cohorts 6, 7, 8, 9 and 10: PK blood samples collected prior to study drug administration on Day 1 and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after the first dose, predose on Days 2-5. On Day 6, samples will be collected predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose.
Updated from
Cohorts 1, 2, 4 and 5: PK blood samples collected prior to study drug administration on Day 1 and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, and 48 hours, and at Day 8. Cohorts 6, 7, 8, 9 and 10: PK blood samples collected prior to study drug administration on Day 1 and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after the first dose, predose on Days 2-5. On Day 6, samples will be collected predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose.  
Reason: - The protocol update was implemented after the completion of SAD Cohort 5 and MAD Cohort 7, after 56 participants had been enrolled and treated
Updated on 21/09/2026 1:58:20 PM
Secondary outcome [2] 453124 0
To evaluate food effect following a single oral dose of RTR242
Timepoint [2] 453124 0
Cohort 3: PK blood samples will be collected predose on Day 1 and 8, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours post dose, and on Day 15.

Eligibility
Key inclusion criteria
- Aged 18-65 years of age inclusive at the time of informed consent;
- Body mass index (BMI) between 18 and 32.0 kg/m2, inclusive;
- Female participants of non-child-bearing potential (either post-menopausal for at least 12 months with no menses and as confirmed by Follice Stimulating Hormone (FSH) level greater than 40 IU/L at Screening, or surgically sterilized by hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), or females of child-bearing potential who must agree to use one of the following appropriate contraceptive methods from informed consent until at least 90 days after the last dose of assigned study drug:
a. Complete abstinence from heterosexual intercourse in line with their preferred and usual lifestyle OR
b. Male condom in combination with a highly effective contraceptive method (established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); bilateral tubal ligation; vasectomized male partner provided they are the sole partner.
- Male participants who agree to use one of the following appropriate contraceptive methods, and agree to refrain from sperm donation, from informed consent until at least 90 days after the last dose of assigned study drug:
a. Complete abstinence from heterosexual intercourse in line with their preferred and usual lifestyle OR
b. Male condom in combination with the female partner using a highly effective contraceptive method (established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); bilateral tubal ligation; vasectomy), OR
c. Exclusively with a female partner of non-childbearing potential (either post-menopausal for at least 12 months, or surgically sterilized by hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)
- Social smokers (using no more than 5 cigarettes or equivalent tobacco/nicotine-containing products per week on average) who are willing to abstain from these products within 48 hours before check-in (Day -1) and throughout confinement;
- Healthy as defined by no clinically significant findings by the Investigator/delegate in review of medical history, physical examination, vital sign measurements, 12-lead ECG and clinical laboratory results from Screening through to pre-dose Day 1 assessments. Repeat assessments are permitted at the discretion of the PI/delegate;
- Conventional 12-lead ECG recorded in triplicate (the mean of triplicate measurements will be used to determine eligibility) consistent with normal cardiac conduction and function during Screening
- Negative nicotine, drug, and alcohol tests during Screening and check-in (Day -1) and willing to abstain from alcohol/illegal drug use until completion of the EOS/ET visit.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
- History of substance misuse in the opinion of the Investigator, or alcohol misuse defined as regular consumption of > 10 standard drinks per week or > 4 standard drinks on any given day, within 12 months prior to Day 1 (1 standard drink being equivalent to 100mL of wine, 30 mL of spirits or 285 mL of mid-strength beer or cider);
- History of suicidal behavior or suicidal ideation; as determined by medical history or by clinically significant findings on the baseline Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening;
- Known active hepatitis B or C infection, human immunodeficiency virus (HIV) infection, or has known immune deficiency disease at Day 1;
- Use of any prescription drug within 30 days prior to Day 1, except for hormonal contraceptives (oral contraceptive pills or implant) for females of child-bearing potential which have been in stable use for at least 2 months;
- Use of over-the-counter (OTC) products including St John’s Wort within 14 days prior to Day 1 through discharge (except for vitamin supplements or paracetamol up to 2 g/day, natural food supplements, garlic as a supplement);
- Vaccines within 30 days before Day 1, and/or planned vaccination through the EOS/ET visit;
- Blood or plasma donation within the past 2 months prior to Day 1, and/or receipt of blood transfusion within 1 month before Day 1;
- Presence or history of any clinically significant condition/disorder (as determined by the Investigator) including but not limited to: allergies, asthma, angioedema, pulmonary disease, bronchospasm, ulcer disease, gastrointestinal (GI), GI bleeding, coagulation defects, unstable angina, myocardial infarction, congestive heart failure, cardiac arrhythmia, bradycardia, tachycardia, hypotension, hypertension, edema, heart failure, hypokalemia, cardiovascular disease, significant dermatologic diseases or conditions, hematological, neurological, psychiatric, hepatic, or renal disorders, condition that would significantly influence the immune response; or history of infections of unexplained frequency or severity;
- Surgical (history of stomach or intestinal surgery or resection) or medical condition (evidence of prior chronic GI inflammatory disease) that would interfere with gastric motility, pH, or absorption that could interfere with the administration of the assigned study drug;
- Received systemic treatment for cancer except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast within the 5 years prior to Day 1;
- Severe allergy or anaphylaxis to any drug or food;
- Use of any investigational drug, investigational device, approved therapy for investigational use or participation in an investigational study within 30 days (or five half-lives of the investigational drug, whichever is longer) prior to Day 1 and/or unwillingness to allow at least 28 days from last dose of assigned study drug before participation in another investigational trial;
- Unwilling to abstain from alcoholic beverages/alcohol-containing products and xanthine-based beverages from 48 hours prior to Day -1 until completion of the EOS/ET visit, poppy seed containing foods from 72 hours prior to Day -1 until discharge, or returns a positive urine drug screen or alcohol breath test at Screening or Day -1;
- Females who are pregnant, plan to donate ova or become pregnant during the study and/or up to for at least 90 days after the last dose of study drug, or are breastfeeding.


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

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

Recruitment
Recruitment status
Recruiting
Updated from
Not yet recruiting  
Reason: Recruitment has commenced
Updated on 21/09/2026 1:58:20 PM
Date of first participant enrolment
Anticipated
Actual
Updated from
 
Updated on 21/09/2026 1:58:20 PM
Date of last participant enrolment
Anticipated
Actual
Updated from
6/04/2026 
Updated on 21/09/2026 1:58:20 PM
Date of last data collection
Anticipated
Actual
Updated from
12/05/2026 
Updated on 21/09/2026 1:58:20 PM
Sample size
Target
Accrual to date
Final
Updated from
76 
Updated on 21/09/2026 1:58:20 PM
Updated from
 
Updated on 21/09/2026 1:58:20 PM
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 28621 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 44850 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 320141 0
Commercial sector/Industry
Name [1] 320141 0
Retro AU Pty Ltd
Country [1] 320141 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Retro Au Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 322708 0
None
Name [1] 322708 0
Address [1] 322708 0
Country [1] 322708 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318687 0
Bellberry Human Research Ethics Committee L
Ethics committee address [1] 318687 0
Ethics committee country [1] 318687 0
Australia
Date submitted for ethics approval [1] 318687 0
17/09/2025
Approval date [1] 318687 0
23/10/2025
Ethics approval number [1] 318687 0

Summary
Brief summary
Updated from
 
Updated on 21/09/2026 1:58:20 PM
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 144942 0
Dr Michele De Sciscio
Address 144942 0
CMAX Clinical Research. Ground Floor, 21-24 North Terrace, Adelaide SA 5000
Country 144942 0
Australia
Phone 144942 0
+61 442 447 902
Fax 144942 0
Email 144942 0
Contact person for public queries
Name 144943 0
Chloe Douglas
Address 144943 0
CMAX Clinical Research. Ground Floor, 21-24 North Terrace, Adelaide SA 5000
Country 144943 0
Australia
Phone 144943 0
+61 8 7088 7900
Fax 144943 0
Email 144943 0
Contact person for scientific queries
Name 144944 0
Dr Edward Greenberg
Updated from
Dr Michele De Sciscio  

Updated on 21/09/2026 1:58:20 PM
Address 144944 0
Retro AU Pty Ltd Level 2, 169 Pirie Street Adelaide, South Australia, 5000
Updated from
CMAX Clinical Research. Ground Floor, 21-24 North Terrace, Adelaide SA 5000  

Updated on 21/09/2026 1:58:20 PM
Country 144944 0
Australia
Phone 144944 0
+1 650 866 0264
Updated from
+61 442 447 902  

Updated on 21/09/2026 1:58:20 PM
Fax 144944 0
Email 144944 0
Updated from

Updated on 21/09/2026 1:58:20 PM

Data sharing statement
Will the study consider sharing individual participant data?
No
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What supporting documents are/will be available?

No Supporting Documents Provided
Results publications and other study-related documents

No Study Results Provided