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Trial registered on ANZCTR
Registration number
ACTRN12625000980437
Ethics application status
Approved
Date submitted
18/08/2025
Date registered
5/09/2025
Date last updated
5/09/2025
Date data sharing statement initially provided
5/09/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
Using a handheld ultrasound to check for collapsed lung (pneumothorax) after lung biopsy procedures
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Scientific title
A feasibility study to investigate the role of ultra-portable thoracic ultrasound in the detection of post-procedural pneumothorax
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Secondary ID [1]
315162
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Nil known
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Universal Trial Number (UTN)
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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:
pneumothorax
338593
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Condition category
Condition code
Respiratory
334894
334894
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Description:
Participants undergoing CT-guided or bronchoscopy-guided lung biopsy were observed with serial ultra-portable thoracic ultrasound (UP-TUS) examinations to detect post-procedural pneumothorax. The device used was a Butterfly iQ+ handheld ultrasound probe (Butterfly Network, Burlington, USA) connected to a smart device with the “lung mode” setting.
Each assessment involved scanning four pre-specified locations per hemithorax to assess for pleural sliding, B-lines, seashore sign, and (where relevant) lung point.
Mode of delivery and timing:
UP-TUS was performed in a semi-recumbent (45-degree) position.
Assessments were conducted at three timepoints:
Pre-procedure (screening, bilateral) to confirm lung sliding.
Immediately post-procedure (ipsilateral side to biopsy).
One hour post-procedure (ipsilateral side).
Who delivered the assessment:
Examinations were performed at the bedside by Thoracic Society of Australia and New Zealand (TSANZ) accredited respiratory clinicians (Respiratory Registrars with greater than 6 years postgraduate experience and Respiratory Physicians).
Location:
Procedures and ultrasound assessments occurred in a tertiary hospital setting (CT suite, bronchoscopy suite, or operating theatre recovery).
Duration/dose:
Each assessment took approximately 9 minutes. Participants received between 2–3 assessments depending on feasibility of the pre-procedural examination. If participants chose not to be involved in the study they may still be investigated with the Butterfly iQ+ at the discretion of the treating physician.
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Intervention code [1]
331780
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Diagnosis / Prognosis
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Comparator / control treatment
All participants underwent standard erect chest radiography (CXR) at approximately 1 hour post-procedure.
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Control group
Active
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Outcomes
Primary outcome [1]
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The sensitivity of ultra-portable thoracic ultrasound in detecting post-procedural pneumothorax, compared with erect chest radiography as the reference standard.
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Assessment method [1]
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This primary outcome was assessed by comparing ultra-portable thoracic ultrasound (UP-TUS) findings from standardised bedside lung scans with erect chest radiograph (CXR) performed one hour post-procedure, calculating the sensitivity of UP-TUS for detection of post-procedural pneumothorax. A pneumothorax was determined to be present if they had pleural sliding on pre-procedural assessment and on either post-procedural assessment had absent sliding or a lung point.
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Timepoint [1]
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This primary outcome was assessed at immediate post-procedure and at one hour post-procedure, corresponding to the timing of ultra-portable thoracic ultrasound (examinations and the one-hour erect chest radiograph reference standard.
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Primary outcome [2]
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The specificity of UP-TUS in detecting post-procedural pneumothorax.
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Assessment method [2]
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This primary outcome was assessed by comparing UP-TUS with the reference standard erected CXR
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Timepoint [2]
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This primary outcome was assessed immediately after procedure and at one hour post-procedure, corresponding to the timing of UP-TUS examinations and erect CXR
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Secondary outcome [1]
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Detection of clinically significant pneumothorax (pre-defined by the presence of symptoms, hypoxia, or requirement for intervention such as chest drain insertion) by ultra-portable ultrasound (UP-TUS) compared with chest radiograph (CXR).
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Assessment method [1]
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Presence of pneumothorax was classified as clinically significant if associated with symptoms (e.g. dyspnoea, hypoxia) or if intervention (e.g. chest drain insertion, hospitalisation) was required, determined by clinical review and medical records, compared between UP-TUS and CXR.
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Timepoint [1]
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One hour post-procedure (timing of CXR), with additional earlier assessment if clinical deterioration has occurred.
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Secondary outcome [2]
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Time to diagnosis of pneumothorax with UP-TUS compared to CXR in the setting of clinical deterioration.
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Assessment method [2]
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This time was calculated from the time of clinical review to the time of imaging modality. This was obtained from medical records and the time stamps on imaging modalities.
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Timepoint [2]
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The time at which the imaging modalities occur
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Secondary outcome [3]
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Cost comparison between UP-TUS and CXR, including total time for CXR, total time for UP-TUS, number of CXR taken, total staff time and disposable costs.
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Assessment method [3]
451477
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This outcome was assessed by calculating the direct cost of UP-TUS and erect CXR, including staff time and disposable item costs. Staff time was derived from the average duration of each assessment multiplied by the hourly wage rate from South Australian Health enterprise agreements (July 2023). Disposable costs included ultrasound gel, CXR plastic bags, and cleaning wipes, these were based on prices from the internal ordering system, Oracle iProcurement. Capital costs for equipment (CXR machines, Butterfly probes, and subscriptions) were excluded.
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Timepoint [3]
451477
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Five patient journeys for each type of procedure were followed and averaged to determine staff time and use of disposable items.
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Secondary outcome [4]
451478
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Qualitative assessment of ultrasound image quality
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Assessment method [4]
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This was assessed by a 5-point Likert score outlining i) total image quality of UP-TUS and ii) ability to see pleural line. The scale was (1) very poor, (2) poor, (3) average, (4) good, (5) excellent.
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Timepoint [4]
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The Likert score was completed by the clinician after all three UP-TUS assessments had taken place.
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Secondary outcome [5]
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Qualitative assessment of a clinician’s confidence in using UP-TUS without CXR to detect a post-procedural pneumothorax
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Assessment method [5]
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This was assessed using a 5-point Likert score outlining 'Would you be happy to use these [UP-TUS] assessments instead of CXR?. The scale was (1) strongly disagree, (2) disagree, (3) neutral, (4) agree, (5) strongly agree.
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Timepoint [5]
451479
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The 5-point Likert score was completed by the clinician after all three UP-TUS examinations were completed
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Eligibility
Key inclusion criteria
We included patients undergoing (1) CT-guided lung biopsy, (2) transbronchial forceps biopsy (TBFB), (3) transbronchial cryobiopsy (TBCB), and (4) radial endobronchial ultrasound (Radial-EBUS) biopsy at Flinders Medical Center.
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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
Exclusion criteria included (1) age under 18 years, (2) participants unable to provide consent due to severe intellectual disability, language barriers or severe psychiatric conditions, (3) if PTX had been diagnosed on the side of biopsy in the preceding 6 weeks, or (4) if an accredited clinician was not available to perform an assessment.
Participants were also excluded from analysis after consent if they (1) did not proceed with a biopsy, or (2) if a chest drain was inserted during the procedure to manage an immediate PTX.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
19/09/2022
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Date of last participant enrolment
Anticipated
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Actual
18/08/2023
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Date of last data collection
Anticipated
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Actual
30/08/2024
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Sample size
Target
159
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Accrual to date
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Final
159
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
28342
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Flinders Medical Centre - Bedford Park
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Recruitment postcode(s) [1]
44560
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5042 - Bedford Park
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
319738
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Flinders Medical Centre
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Address [1]
319738
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Country [1]
319738
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Australia
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Primary sponsor type
Individual
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Name
Dr Emelie Ross - Flinders Medical Centre
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Address
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Country
Australia
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Secondary sponsor category [1]
322243
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None
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Name [1]
322243
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Address [1]
322243
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Country [1]
322243
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
318288
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Southern Adelaide Clinical Human Research Ethics Committee
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Ethics committee address [1]
318288
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https://www.sahealth.sa.gov.au/wps/wcm/connect/Public+Content/SA+Health+Internet/About+us/Our+Local+Health+Networks/Southern+Adelaide+Local+Health+Network/Research/For+Researchers/Southern+Adelaide+Clinical+Human+Research+Ethics+Committee
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Ethics committee country [1]
318288
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Australia
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Date submitted for ethics approval [1]
318288
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27/03/2022
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Approval date [1]
318288
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25/05/2022
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Ethics approval number [1]
318288
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2022\HRE00074
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Summary
Brief summary
This study looked at whether a small handheld ultrasound device can accurately detect collapsed lung (pneumothorax) after a lung biopsy. Currently, patients are usually checked with a chest X-ray, but this takes time and requires special equipment. We believed that handheld ultrasound would provide faster results at the bedside without radiation exposure. The study compared ultrasound findings with chest X-ray results to see how accurate the device is, particularly for clinically important cases that need treatment. We will also look at how quickly each test provides answers and compare their overall costs.
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Trial website
N/A
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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 Emelie Ross
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Address
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Flinders Medical Centre, Flinders Drive, Bedford Park, SA 5042
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Country
143714
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Australia
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Phone
143714
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+61479067257
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Fax
143714
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Email
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[email protected]
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Contact person for public queries
Name
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Emelie Ross
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Address
143715
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Flinders Medical Centre, Flinders Drive, Bedford Park, SA 5042
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Country
143715
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Australia
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Phone
143715
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+61479067257
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Fax
143715
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Email
143715
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[email protected]
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Contact person for scientific queries
Name
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Emelie Ross
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Address
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Flinders Medical Centre, Flinders Drive, Bedford Park, SA 5042
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Country
143716
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Australia
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Phone
143716
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+61479067257
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Fax
143716
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Email
143716
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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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