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Trial registered on ANZCTR
Registration number
ACTRN12621000962831
Ethics application status
Approved
Date submitted
24/05/2021
Date registered
23/07/2021
Date last updated
29/06/2022
Date data sharing statement initially provided
23/07/2021
Date results information initially provided
29/06/2022
Type of registration
Retrospectively registered
Titles & IDs
Public title
Acute Management of Spinal Cord Injury
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Scientific title
A retrospective observational clinical research of current practice in the acute assessment and intensive care management of traumatic spinal cord injury
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Secondary ID [1]
304292
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None
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Universal Trial Number (UTN)
None
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Trial acronym
AMOSCI
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Linked study record
None
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Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury
322024
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Condition category
Condition code
Injuries and Accidents
319747
319747
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0
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Other injuries and accidents
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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
This retrospective observational cohort study will review the eligible participants' demographics, details of the injury and associated injuries, comorbidities, emergency, surgical and intensive care management including neurological assessment, blood pressure management, imaging results and operative management over the initial 7 days following acute traumatic spinal cord injury.
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Intervention code [1]
320632
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
327609
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The lowest blood pressure measured in the first 24 hours from patient medical records documentation.
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Assessment method [1]
327609
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Timepoint [1]
327609
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24 hours post injury
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Primary outcome [2]
327883
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A composite primary outcome. The timing of the initial neurological examination and the proportion of participants that have a complete International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examination within 72 hours of initial hospital admission from patient medical records documentation.
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Assessment method [2]
327883
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Timepoint [2]
327883
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72 hours post injury
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Primary outcome [3]
327884
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A composite primary outcome. The average blood pressure (MAP and SBP in mmHg) measured over 7 days following the injury from patient medical records documentation.
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Assessment method [3]
327884
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Timepoint [3]
327884
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7 days post injury
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Secondary outcome [1]
395940
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The proportion of patients admitted to the ICU from patient medical records documentation.
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Assessment method [1]
395940
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Timepoint [1]
395940
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24 hours, 72 hours and 7 days post injury
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Secondary outcome [2]
397845
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The proportion of patients receiving vasopressor support from patient medical records documentation.
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Assessment method [2]
397845
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Timepoint [2]
397845
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24 hours, 72 hours and 7 days post injury
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Secondary outcome [3]
397846
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The median duration of vasopressor support from patient medical records documentation,
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Assessment method [3]
397846
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Timepoint [3]
397846
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24 hours, 72 hours and 7 days post injury
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Secondary outcome [4]
397847
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The median duration of ICU from patient medical records documentation.
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Assessment method [4]
397847
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Timepoint [4]
397847
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24 hours, 72 hours and 7 days post injury
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Secondary outcome [5]
397848
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The incidence of complication rate of vasopressor treatment from patient medical records documentation.
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Assessment method [5]
397848
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Timepoint [5]
397848
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24 hours, 72 hours and 7 days post injury
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Secondary outcome [6]
398687
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The median hospital length of stay from patient medical records documentation.
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Assessment method [6]
398687
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Timepoint [6]
398687
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24 hours, 72 hours and 7 days post injury
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Eligibility
Key inclusion criteria
Adult patients (>=16 years)
Admitted to participating Spinal Cord Injury Units
Between January 2018 and January 2020
Acute traumatic spinal cord injury as documented by ICD coding
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Minimum age
16
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
Transferred to participating spinal injury units more than 7 days following injury
Unable to access pre-hospital and ED records
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Retrospective
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Statistical methods / analysis
Baseline and process data will be summarised using means and standard deviations, median and interquartile range and counts and proportions as appropriate.
We will report the mean and standard deviation for the lowest recorded BP the first 24 hours, as well as the proportion of patients with a documented systolic blood pressure of < 90 mmHg.
Secondary outcomes will be expressed as a percentage, median duration, or incidence as required.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
1/07/2021
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Date of last participant enrolment
Anticipated
31/12/2021
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Actual
27/01/2022
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Date of last data collection
Anticipated
31/12/2021
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Actual
27/01/2022
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Sample size
Target
100
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
19521
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Prince of Wales Hospital - Randwick
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Recruitment hospital [2]
19522
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Royal North Shore Hospital - St Leonards
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Recruitment postcode(s) [1]
34120
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2031 - Randwick
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Recruitment postcode(s) [2]
34121
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2065 - St Leonards
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Funding & Sponsors
Funding source category [1]
308666
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Government body
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Name [1]
308666
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South Eastern Sydney Local Health District
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Address [1]
308666
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District Executive Unit, Level4
The Sutherland Hospital & Community Health Service
Cnr The Kingsway & Kareena Road
Caringbah NSW 2229
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Country [1]
308666
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Australia
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Primary sponsor type
Government body
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Name
South Eastern Sydney Local Health District
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Address
District Executive Unit, Level4
The Sutherland Hospital & Community Health Service
Cnr The Kingsway & Kareena Road
Caringbah NSW 2229
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Country
Australia
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Secondary sponsor category [1]
309545
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Government body
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Name [1]
309545
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Northern Sydney Local Health District
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Address [1]
309545
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Royal North Shore Hospital
Reserve Road
St Leonards NSW 2065
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Country [1]
309545
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Australia
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Other collaborator category [1]
281795
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Other Collaborative groups
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Name [1]
281795
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Neuroscience Research Australia
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Address [1]
281795
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Margarete Ainsworth Building
Barker Street
Randwick NSW 2031
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Country [1]
281795
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
308593
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South Eastern Sydney Local Health District HREC
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Ethics committee address [1]
308593
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SESLHD Research Support Office
Prince of Wales Hospital
Baker Street
Randwick NSW 2031
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Ethics committee country [1]
308593
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Australia
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Date submitted for ethics approval [1]
308593
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21/04/2021
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Approval date [1]
308593
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16/06/2021
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Ethics approval number [1]
308593
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2021/ETH00493
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Summary
Brief summary
Spinal cord injury is devastating injury with significant functional and financial cost. Long term outcomes vary and depend on early injury factors and prevention of secondary neurological injury. This is a retrospective cohort study. The aim of this study is to identify current practice with reference to factors that influence prognostication and prevention of secondary neurological injury. These are early documentation of neurological status, and defence of blood pressure targets in keeping with international guidelines. Identifying current practice will facilitate design of future studies that aim to investigate long term outcomes. The primary objective of this study to describe current practice in the acute assessment and intensive care (ICU) management of spinal cord injury, with respect to timing and documentation of neurological status after injury, and acute blood pressure management in ICU.
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Trial website
None
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Trial related presentations / publications
None
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Public notes
This retrospective observational study will be conducted in compliance with all stipulations of this protocol, the conditions of ethics committee approval, the NHMRC National Statement on Ethical Conduct in Human Research (2007) and the Note for Guidance on Good Clinical Practice (CPMP/ICH-135/95).
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Contacts
Principal investigator
Name
111258
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Dr Tessa Garside
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Address
111258
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Intensive Care Unit
Royal North Shore Hospital
Reserve Road
St Leonards NSW 2065
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Country
111258
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Australia
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Phone
111258
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+61 02 9926 7111
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Fax
111258
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None
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Email
111258
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[email protected]
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Contact person for public queries
Name
111259
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Mr Trent Li
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Address
111259
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Department of Orthopaedic Surgery
Level 2 South Wing Edmund Blacket Building
Prince of Wales Hospital
Barker Street
Randwick NSW 2031
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Country
111259
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Australia
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Phone
111259
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+61 02 9382 2490
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Fax
111259
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+61 02 9382 2889
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Email
111259
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[email protected]
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Contact person for scientific queries
Name
111260
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Dr Tessa Garside
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Address
111260
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Intensive Care Unit
Royal North Shore Hospital
Reserve Road
St Leonards NSW 2065
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Country
111260
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Australia
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Phone
111260
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+61 02 9926 7111
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Fax
111260
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None
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Email
111260
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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)?
No
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No/undecided IPD sharing reason/comment
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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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