301 Supplementary material | Appendix C A Section/Topic Item No Checklist item Reported on page No Outcomes and estimation 17a For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Table 2 17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended Table 2 Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory 153, Table 3 Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) NA (negative effects are discussed in results section) Discussion Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses 156-158 Generalisability 21 Generalisability (external validity, applicability) of the trial findings 158 Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence 154-158 Other information Registration 23 Registration number and name of trial registry 128, 134 Protocol 24 Where the full trial protocol can be accessed, if available 134 Funding 25 Sources of funding and other support (such as supply of drugs), role of funders See published article *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.
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