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Trial registered on ANZCTR
Registration number
ACTRN12618001122246p
Ethics application status
Not yet submitted
Date submitted
28/06/2018
Date registered
6/07/2018
Date last updated
6/07/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Comparing two different sedation techniques (midazolam or no-midazolam) to sedate patients undergoing electrical shock for arrhythmia
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Scientific title
Midazolam vs placebo for sedation for elective cardioversion, effect on awareness and airway complications
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Secondary ID [1]
295349
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Nil known
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Universal Trial Number (UTN)
U1111-1216-3967
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation
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Atrial flutter
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Condition category
Condition code
Cardiovascular
307521
307521
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Patients will be those already admitted to the Critical Care Ward of Toowoomba Hospital for the purposes of electrical cardioversion for a stable atrial arrhythmia. Their participation in the trial will not involve any additional stay in hospital.
Patient will be randomised into one of two groups. One will receive midazolam, fentanyl and propofol. The other will receive placebo, fentanyl and propofol.
The fentanyl dose will be between 20 and 200ug, delivered as a single dose intravenously, with the dose determined by patient factors such as age, weight and co-morbidities.
The propofol dose will be between 20 and 200mg, delivered as small repeated doses (of 10 to 50mg) over between one and five minutes, titrated to patient conscious state.
The midazolam (or placebo) dose will be between 1 and 5mg, delivered as a single intravenous dose, with the dose determined by patient factors (age, weight, co-morbidites and prior alcohol or benzodiazepine exposure).
The medications will be administered in the following order:
Midazolam will be administered as the first medication, and given 1 to 3 minutes to have effect.
Fentanyl will be administered next, and given 30 seconds to one minute to have effect.
Propofol will be the final medication administered, and titrated to effect, with approximately 30 seconds between doses.
All medications will be administered by an intensive care doctor who has received education about the research project. The medications will be prepared by a senior intensive care nurse, with only this nurse being aware whether they have prepared midazolam or placebo (as decided by randomisation via sealed numbered envelopes). The nurse who has prepared the medication will have no role in the administration of the drugs or collecting data relating to the trial.
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Intervention code [1]
301671
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Treatment: Drugs
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Comparator / control treatment
Placebo will be used in place of midazolam. This will be prepared by an independent nurse, and will consist of 0.9% saline, with a 'midazolam or placebo' label placed on the syringe.
The fentanyl dose will be between 20 and 200ug, delivered as a single dose intravenously, with the dose determined by patient factors such as age, weight and co-morbidities.
The propofol dose will be between 20 and 200mg, delivered as small repeated doses (of 10 to 50mg) over between one and five minutes, titrated to patient conscious state.
The timing of the medication administration will be identical to the intervention group.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Requirement for any airway or respiratory support. This is a composite of a number of secondary outcomes.
This will be assessed by direct observation by a clinician who has received education regarding the trial. Data collection will be performed contemporaneously with the sedation procedure.
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Assessment method [1]
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Timepoint [1]
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During the sedation procedure (approximately ten minutes)
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Primary outcome [2]
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Awareness of electrical shock/pain during cardioversion
This will be assessed after the sedation procedure has been completed and the patient has recovered enough to be alert without stimulus, and aware of their surroundings. They will be asked if they have any memory of the electrical cardioversion, and if so will be asked how unpleasant it was on a scale from 1 to 10.
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Assessment method [2]
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Timepoint [2]
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This will be assessed between five and sixty minutes after the procedure, after the patient is deemed to have fully recovered from their sedation.
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Secondary outcome [1]
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Desaturation below 90%, determined by direct observation of the saturations as recorded continuously on the bedside monitor.
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Assessment method [1]
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Timepoint [1]
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During the sedation procedure (approximately ten minutes)
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Secondary outcome [2]
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Desaturation below 80%, determined by direct observation of the saturations as recorded continuously on the bedside monitor.
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Assessment method [2]
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Timepoint [2]
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During the sedation procedure (approximately ten minutes)
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Secondary outcome [3]
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Requirement for bag-mask ventilation, determined by direct observation of the patient by a trained observer.
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Assessment method [3]
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Timepoint [3]
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During the sedation procedure (approximately ten minutes)
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Secondary outcome [4]
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Requirement for airway adjunct (Guedel's airway, nasopharyngeal airway), determined by direct observation of the patient by a trained observer.
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Assessment method [4]
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Timepoint [4]
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During the sedation procedure (approximately ten minutes)
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Secondary outcome [5]
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Hypotension below systolic pressure 90, determined by direct observation of the blood pressure on the bedside monitor, with a non-invasive blood pressure taken at least every 2.5 minutes, and observed by a trained observer.
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Assessment method [5]
348692
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Timepoint [5]
348692
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During the sedation procedure (approximately ten minutes)
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Secondary outcome [6]
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Time to patient obeying commands post cardioversion, as observed by a trained observer. The patient will be asked to raise both arms off the bed, and will meet the requirements if both elbows are seen to be supported against gravity.
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Assessment method [6]
348693
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Timepoint [6]
348693
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During the sedation procedure (approximately ten minutes)
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Eligibility
Key inclusion criteria
Admission to the Critical Care ward for non-emergent cardioversion
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Minimum age
18
Years
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Maximum age
No limit
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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
Reduced cardiorespiratory reserve such that a potentially higher dose of propofol required in the absence of midazolam may be detrimental
Contraindiation to use of any of the intended sedative drugs (midazolam, an opiate, propofol)
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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)
Sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by shuffling of sealed envelopes prior to study commencement
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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 administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Sample size of 102 patients will give an 80% power to detect a 50% reduction in the need for airway support, with a p-value of 0.05
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
20/08/2018
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Actual
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Date of last participant enrolment
Anticipated
1/08/2019
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Actual
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Date of last data collection
Anticipated
1/08/2019
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Actual
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Sample size
Target
102
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Toowoomba Hospital - Toowoomba
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Recruitment postcode(s) [1]
23137
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4350 - Toowoomba
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Toowoomba Hospital
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Address [1]
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Toowoomba Hospital
Pechey Street
Toowoomba, Queensland, Australia, 4350
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Country [1]
299942
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Australia
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Primary sponsor type
Individual
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Name
Dr Adam Visser
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Address
c/o Critical Care Ward
Toowoomba Hospital
Pechey Street
Toowoomba, Queensland 4350
Australia
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Dr Chris Wagner
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Address [1]
299319
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c/o Critical Care Ward
Toowoomba Hospital
Pechey Street
Toowoomba, Queensland 4350
Australia
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Country [1]
299319
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Australia
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
300809
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Darling Downs Hospital and Health Service Human Research Ethics Committee
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Ethics committee address [1]
300809
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HREC Coordinator
Level 5
Surgical Block
Toowoomba Hospital
Private Mail Bag 2
Toowoomba, Queensland 4350
Australia
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Ethics committee country [1]
300809
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Australia
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Date submitted for ethics approval [1]
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23/07/2018
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Approval date [1]
300809
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Ethics approval number [1]
300809
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Summary
Brief summary
Patients who present for elective/non-emergent electrical cardioversion for atrial arrhythmias require sedation for the procedure. A combination of drugs, often including midazolam, a sedative that causes respiratory depression, is typically used.
We hypothesise that removing midazolam from the combination of drugs used will result in a lower need for airway and breathing rescue techniques, without increasing patient's memory for the cardioversion procedure.
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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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Dr Adam Visser
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Address
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c/o Critical Care Ward
Toowoomba Hospital
Pechey Street
Toowoomba, Queensland 4350
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Country
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Australia
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Phone
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+61 7 4616 6422
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Fax
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+61 7 4616 6071
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Email
84882
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[email protected]
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Contact person for public queries
Name
84883
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Dr Adam Visser
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Address
84883
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c/o Critical Care Ward
Toowoomba Hospital
Pechey Street
Toowoomba, Queensland 4350
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Country
84883
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Australia
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Phone
84883
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+61 7 4616 6422
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Fax
84883
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+61 7 4616 6071
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Email
84883
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[email protected]
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Contact person for scientific queries
Name
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Dr Adam Visser
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Address
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c/o Critical Care Ward
Toowoomba Hospital
Pechey Street
Toowoomba, Queensland 4350
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Country
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Australia
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Phone
84884
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+61 7 4616 6422
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Fax
84884
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+61 7 4616 6071
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Email
84884
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[email protected]
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No information has been provided regarding IPD availability
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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