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Research Methods

checklist of information to include when reporting a randomised trial

Title and abstract

  1. Identification as a randomised trial in the title

  2. Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)

Introduction: Background and Objectives

  1. Scientific background and explanation of rationale.
  2. Specific Objecives or hypothesis


  1. Trial Design
    1. Description of trial design (such as parallel, factorial) including allocation ratio
    2. Important changes to methods after trial commencement (such as eligibility criteria), with reasons
  2. Participants
    1. Eligibility criteria for participants
    2. Settings and locations where the data were collected