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Table 1 CONSORT 2010 checklist of information to include when reporting a randomised trial*

From: CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials

Section/Topic Item No Checklist item Reported on page No
Title and abstract
  1a Identification as a randomised trial in the title  
  1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts [21, 31])  
Introduction
Background and objectives 2a Scientific background and explanation of rationale  
  2b Specific objectives or hypotheses  
Methods
Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio  
  3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons  
Participants 4a Eligibility criteria for participants  
  4b Settings and locations where the data were collected  
Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered  
Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed  
  6b Any changes to trial outcomes after the trial commenced, with reasons  
Sample size 7a How sample size was determined  
  7b When applicable, explanation of any interim analyses and stopping guidelines  
Randomisation:    
   Sequence generation 8a Method used to generate the random allocation sequence  
  8b Type of randomisation; details of any restriction (such as blocking and block size)  
   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  
   Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions  
Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how  
  11b If relevant, description of the similarity of interventions  
Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes  
  12b Methods for additional analyses, such as subgroup analyses and adjusted analyses  
Results
Participant flow (a diagram is strongly recommended) 13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome  
  13b For each group, losses and exclusions after randomisation, together with reasons  
Recruitment 14a Dates defining the periods of recruitment and follow-up  
  14b Why the trial ended or was stopped  
Baseline data 15 A table showing baseline demographic and clinical characteristics for each group  
Numbers analysed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups  
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)  
  17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended  
Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory  
Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms [28])  
Discussion
Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses  
Generalisability 21 Generalisability (external validity, applicability) of the trial findings  
Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence  
Other information
Registration 23 Registration number and name of trial registry  
Protocol 24 Where the full trial protocol can be accessed, if available  
Funding 25 Sources of funding and other support (such as supply of drugs), role of funders  
  1. *We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration [13] for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials [11], non-inferiority and equivalence trials [12], non-pharmacological treatments [32], herbal interventions [33], and pragmatic trials [34]. Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see http://www.consort-statement.org/.