Protocol Paper Abstract Template
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Edited abstract information will appear in the published version of the protocol paper
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All protocol titles should include the text “Protocol for a (insert relevant study design)” at
the end of the title
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Please submit your protocol abstract as your ‘Manuscript’ file via the Elsevier Editorial
System.
The following information must be included in the protocol abstract:
Study title:
Author names:
Institutional affiliations:
Abstract: 1 page, approximately 600-700 words
Use subheadings as appropriate (Introduction, Research Questions, Design, Participants and
Setting, Intervention, Control, Measurements, Procedure, Analysis, Discussion/Significance).
Trial registration:
Registration number:
Was this trial prospectively registered?
Date of trial registration:
Funded by:
Funder approval number:
Anticipated completion date:
Provenance:
Corresponding author contact details:
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Full protocol checklist
If accepted for publication, the full study protocol will be made available on the Journal’s
website exactly as submitted (ie without copy-editing).
Full protocols should be
accompanied by a cover page listing the study title, authors, and protocol date or version
number.
The following checklist summarises the information that should be included in the full study
protocol, where relevant:

Study title
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Human research ethics approval committee
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Human research ethics approval number
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Introduction / Background
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Design
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Methods
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Setting
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Participants
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Details of the intervention and control
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Primary and secondary outcome measures and assessment points
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Recruitment procedures
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Randomisation procedures
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Masking/blinding
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Anticipated dates of trial commencement and completion
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Statistical analysis including sample size calculations
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References

Conflict of interest declaration

Acknowledgments
Please submit your full study protocol document as a ‘Supplementary content’ file via the
Elsevier Editorial System.
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