299 Supplementary material | Appendix C A APPENDIX C CONSORT 2010 CHECKLIST CONSORT 2010 checklist of information to include when reporting a randomised trial* Section/Topic Item No Checklist item Reported on page No Title and abstract 1a Identification as a randomised trial in the title 127 1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) 128 Introduction Background and objectives 2a Scientific background and explanation of rationale 130-132 2b Specific objectives or hypotheses 133 Methods Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio 133 3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons NA Participants 4a Eligibility criteria for participants 134 4b Settings and locations where the data were collected 133 Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 137-138 Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 138-139 6b Any changes to trial outcomes after the trial commenced, with reasons NA Sample size 7a How sample size was determined 134 7b When applicable, explanation of any interim analyses and stopping guidelines NA Randomisation: Sequence generation 8a Method used to generate the random allocation sequence 133 8b Type of randomisation; details of any restriction (such as blocking and block size) 133 Allocation concealment mechanism 9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 133
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