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Trial registered on ANZCTR
Registration number
ACTRN12624001162505
Ethics application status
Approved
Date submitted
5/09/2024
Date registered
24/09/2024
Date last updated
24/09/2024
Date data sharing statement initially provided
24/09/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
low dose naltrexone in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and long coronavirus disease (long COVID) symptoms
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Scientific title
Low Dose Naltrexone for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Long COVID Condition
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Secondary ID [1]
311507
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Nil
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Universal Trial Number (UTN)
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Trial acronym
TreatMELC study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
332843
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Long COVID
332844
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Condition category
Condition code
Other
329558
329558
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0
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Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
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Infection
331631
331631
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0
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Other infectious diseases
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Neurological
331632
331632
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0
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Other neurological disorders
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Respiratory
331633
331633
0
0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will start at 1.5mg/day and will increase their dose by 1.5mg/day weekly until their maximum dose is reached (target 4-6mg/day) for 12 weeks. In this clinical trial, Naltrexone will be administered to all ME/CFS and long COVID-19 who meet the recruitment criteria from the clinicians.
Low dose naltrexone will be administered in oral capsules. Placebo participants will receive an exact replica capsule. LDN and placebo capsule will be distributed to participants via post.
The study treatment will be received by the Wesley Hospital Pharmacy designated staff, handled, and stored safely within a secure location to which only pharmacy staff have access. Upon receipt, all investigational products will be stored according to the instructions specified on the labels. The investigators will maintain an accurate record of the shipment and dispensing of study treatment in a drug accountability log. Monitoring of drug accountability will be performed by the study investigators. Participants will keep a drug diary for daily completion for investigators to monitor.
Participants will be asked to return all unused study treatments and package at the end of either a dose escalation, end of the study trial, or discontinuation of the treatment. Returned investigational products will be assessed for compliancy.
Compliance will be assessed by the investigators at the end of each month using pill return counts and information provided by the patient. This information should be captured in the source documents at each visit. All study treatment dispensed and returned must be recorded in the drug accountability log. The site will also be required to complete the appropriate dosage administration record to report any study drug regimen changes or interruptions.
For all medications (other than study regimen) initiated after the start of the study, the reasons for prescribing the medication, the start date, and, where applicable, the end dates will be recorded in the participant’s file.
Information regarding the administration of rescue medication will be recorded in the participant’s file.
Participants will receive instructions to notify investigators of any new medications they take after the participant has enrolled in the study. All medications, procedures, and significant non-drug therapies (e.g., physical therapy and blood transfusions) administered after the patient has enrolled will be recorded.
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Intervention code [1]
327957
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Treatment: Drugs
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Intervention code [2]
327958
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Early detection / Screening
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Comparator / control treatment
Participants in the control group will recieve a placebo gelatin capsule
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Change in the Transient receptor potential cation channel subfamily M member 3 (TRPM3) function
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Assessment method [1]
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Assessed using the gold standard patch-clamp technique
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Timepoint [1]
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12 weeks after intervention commencement.
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Primary outcome [2]
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Assess brain function by examining functional connectivity, changes in brain neurochemicals, myelin, iron and brain structure. This will be assessed as a composite outcome
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Assessment method [2]
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Assessed by Magnetic Resonance Imaging (MRI)
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Timepoint [2]
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12 weeks after intervention commencement
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Secondary outcome [1]
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General quality of life
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Assessment method [1]
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SF-36 questionnaire
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Timepoint [1]
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12 weeks after intervention commencement.
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Secondary outcome [2]
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Disability assessment
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Assessment method [2]
439669
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WHODAS questionnaire
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Timepoint [2]
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12 weeks after intervention commencement
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Secondary outcome [3]
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ME/CFS symptoms assessment
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Assessment method [3]
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Depaul questionnaire
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Timepoint [3]
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12 weeks after intervention commencement
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Eligibility
Key inclusion criteria
i. Aged between 18 and 65 years of age
ii. BMI between 18.5 and 29.9
iii. Diagnosed with ME/CFS by a physician at least 6 months ago.
iv. Diagnosed with Long COVID according to WHO working case definition and present with the following symptoms: cognitive disturbances otherwise known as brain fog, sleep disturbances, and/or body pain. This clinical trial will not assess symptoms including gastrointestinal upset, autonomic or orthostatic intolerances, and respiratory difficulties.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
i. Current respiratory infections
ii. Intercurrent SARS-CoV-2 reinfection during trial period (this will be considered drop-out)
iii. Chronic pain history
iv. Adverse reaction to LDN or compounded constituents
v. Chronic opioid or substitution therapy
vi. Daily opioid use in three months prior to, or during trial
vii. Substance abuse, dependence, addiction
viii. History of drug, alcohol abuse and recreational drugs
ix. Smoking within last 2 years
x. Pregnancy or breastfeeding
xi. Renal dysfunction (eGFR less than or equal to 30 ml/min/1.73m2), liver dysfunction (ALT or AST greater than 300 IU/L).
xii. Active cancer.
xiii. Inflammatory (rheumatological, GIT, dermatological) or neurological condition (demyelinating).
xiv. Neuroimmune modulators: DMARDs, steroids, minocycline, metformin.
xv. Major psychiatric history, self-harm.
xvi. Language, cognition, no computer literacy.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed: central randomisation by phone/fax/computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
15/10/2024
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Actual
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Date of last participant enrolment
Anticipated
12/06/2029
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Actual
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Date of last data collection
Anticipated
14/10/2029
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Actual
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Sample size
Target
56
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Funding & Sponsors
Funding source category [1]
315797
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University
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Name [1]
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Griffith University
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Address [1]
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Country [1]
315797
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Australia
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Primary sponsor type
University
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Name
Griffith University
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Address
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Country
Australia
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Secondary sponsor category [1]
318054
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None
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Name [1]
318054
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Address [1]
318054
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Country [1]
318054
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314655
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Griffith University Human Research Ethics Committee
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Ethics committee address [1]
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https://www.griffith.edu.au/research/research-services/research-ethics-integrity/human/human-research-ethics-committee
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Ethics committee country [1]
314655
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Australia
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Date submitted for ethics approval [1]
314655
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28/05/2024
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Approval date [1]
314655
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03/09/2024
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Ethics approval number [1]
314655
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Summary
Brief summary
There is no laboratory-based diagnostic test and universally accepted treatment for ME/CFS and Long COVID, instead diagnosis follows fulfilment of a diagnostic criteria. The study aims to determine if treatment with Low Dose Naltrexone (LDN) improves ion channels function, fatigue, cognitive, neurological symptoms, and health-related quality-of-life (HRQoL) in adults with ME/CFS and Long COVID. If this is the case, Low Dose Naltrexone (LDN) may offer a safe and cost-effective treatment for ME/CFS and Long COVID. The investigational production Low Dose Naltrexone (LDN) will be manufactured, packaged, labelled, coded, stored, supplied, and handled in accordance with the requirements of sections 5.13 and 5.14 of the Therapeutic Goods Administration’s Integrated Addendum. Specifically, Low Dose Naltrexone (LDN) will be manufactured in accordance with good manufacturing practices (GMP) and will be coded or labelled by the compounding pharmacy. While Low Dose Naltrexone (LDN) and placebo will be blinded, a coding system will be implemented to enable rapid identification of the product for safety reasons. Specifically, Low Dose Naltrexone (LDN) capsules are to be stored at room temperature in their original container for up to six months. Low Dose Naltrexone (LDN) will be labelled with a specific expiration date by the compounding pharmacy.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Sonya Marshall-Gradisnik
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Address
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G40 Griffith Health Centre, Griffith University, Parklands Drive Gold Coast QLD 4222
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Country
132302
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Australia
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Phone
132302
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+61 0756780725
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Fax
132302
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Email
132302
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[email protected]
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Contact person for public queries
Name
132303
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Sonya Marshall-Gradisnik
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Address
132303
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G40 Griffith Health Centre, Griffith University, Parklands Drive Gold Coast QLD 4222
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Country
132303
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Australia
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Phone
132303
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+61 0756780725
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Fax
132303
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Email
132303
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[email protected]
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Contact person for scientific queries
Name
132304
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Sonya Marshall-Gradisnik
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Address
132304
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G40 Griffith Health Centre, Griffith University, Parklands Drive Gold Coast QLD 4222
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Country
132304
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Australia
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Phone
132304
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+61 0756780725
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Fax
132304
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Email
132304
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Fully de-identified study data underlying published results.
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When will data be available (start and end dates)?
Beginning 1 year after the end of study data collection, and for up to 5 years post completion of study data collection.
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Available to whom?
On a case-by-case basis at the discretion of the study sponsor.
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Available for what types of analyses?
Group and paired analysis.
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How or where can data be obtained?
Access subject to approval by Principal Investigator
Email:
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
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.
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