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????? CONSORT2010 checklist of information to include when reporting a randomised trial We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials. Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org. Title and Abstract 1a. Title Identification as a randomisedtrial in the title. 1b. Abstract Structured summary of trialdesign, methods, results, and conclusions Introduction 2a. Background Scientific background andexplanation of rationale 2b. Objectives Specific objectives or hypotheses Methods 3a. Trial Design Description of trial design (suchas parallel, factorial) including allocation ratio 3b. Changes to trial design Important changes to methodsafter trial commencement (such as eligibility criteria), with reasons 4a. Participants Eligibility criteria forparticipants 4b. Study settings Settings and locations where thedata were collected 5. Interventions The interventions for each groupwith sufficient details to allow replication, including how and when they wereactually administered 6a. Outcomes Completely defined pre-specifiedprimary and secondary outcome measures, including how and when they wereassessed 6b. Changes to outcomes Any changes to trial outcomesafter the trial commenced, with reasons 7a. Sample size How sample size was determined 7b. Interim analyses and stoppingguidelines When applicable, explanation ofany interim analyses and stopping guidelines 8a. Randomisation: sequencegeneration Method used to generate therandom allocation sequence 8b. Randomisation: type Type of randomisation; details ofany restriction (such as blocking and block size) 9. Randomisation: allocationconcealment mechanism Mechanism used to implement therandom allocation sequence (such as sequentially numbered containers),describing any steps taken to conceal the sequence until interventions wereassigned 10. Randomisation: implementation Who generated the allocationsequence, who enrolled participants, and who assigned participants tointerventions 11a. Blinding If done, who was blinded afterassignment to interventions (for example, participants, care providers, thoseassessing outcomes) and how 11b. Similarity ofinterventions If relevant, description of thesimilarity of interventions 12a. Statistical methods Statistical methods used tocompare groups for primary and secondary outcomes 12b. Additional analyses Methods for additional analyses,such as subgroup analyses and adjusted analyses Results 13a. Participant Flow For each group, the numbers ofparticipants who were randomly assigned, received intended treatment, and wereanalysed for the primary outcome 13b. Losses and exclusions For each group, losses andexclusions after randomisation, together with reasons 14a. Recruitment Dates defining the periods ofrecruitment and follow-up 14b. Reason for stoppedtrial Why the trial ended or wasstopped 15. Baseline Data A table showing baselinedemographic and clinical characteristics for each group 16. Numbers analysed For each group, number ofparticipants (denominator) included in each analysis and whether the analysiswas by original assigned groups 17a. Outcomes andestimation For each primary and secondaryoutcome, results for each group, and the estimated effect size and itsprecision (such as 95% confidence interval) 17b. Binary outcomes For binary outcomes, presentationof both absolute and relative effect sizes is recommended 18. Ancillaryanalyses Results of any other analysesperformed, including subgroup analyses and adjusted analyses, distinguishingpre-specified from exploratory 19. Harms All important harms or unintendedeffects in each group Discussion 20. Limitations Trial limitations, addressingsources of potential bias, imprecision, and, if relevant, multiplicity ofanalyses 21. Generalisability Generalisability (externalvalidity, applicability) of the trial findings 22. Interpretation Interpretation consistent withresults, balancing benefits and harms, and considering other relevant evidence Other information 23. Registration Registration number and name oftrial registry 24. Protocol Where the full trial protocol canbe accessed, if available 25. Funding Sources of funding and othersupport (such as supply of drugs), role of funders
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