Section/Topic Item No Checklist item Reported on page No
Title and abstract Title and abstract Title and abstract Title and abstract
1a Identification as a randomised trial in the title Page 1
1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) Page 1
Introduction Introduction Introduction Introduction
Background and objectives 2a Scientific background and explanation of rationale Page 2
2b Specific objectives or hypotheses Page 2
Methods Methods Methods Methods
Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio Page 3-4
3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons Page 3-4
Participants 4a Eligibility criteria for participants Page 3-4
4b Settings and locations where the data were collected Page 3-4
Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered Page 3-4
Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Page 3-4
6b Any changes to trial outcomes after the trial commenced, with reasons Page 3-4
Sample size 7a How sample size was determined Page 3-4
7b When applicable, explanation of any interim analyses and stopping guidelines Page 3-4
Randomisation:
 Sequence generation 8a Method used to generate the random allocation sequence Page 3-4 & Fig 1
8b Type of randomisation; details of any restriction (such as blocking and block size) Page 3-4 & Fig 1
 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 Page 3-4 & Fig 1
 Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Page 3-4 & Fig 1
Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how Page 3-4 & Fig 1
11b If relevant, description of the similarity of interventions Page 3-4 & Fig 1
Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes Page 3-4
12b Methods for additional analyses, such as subgroup analyses and adjusted analyses Page 3-4
Results Results Results 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 Page 5-6
13b For each group, losses and exclusions after randomisation, together with reasons Page 5-6
Recruitment 14a Dates defining the periods of recruitment and follow-up Page 5-6
14b Why the trial ended or was stopped Page 5-6
Baseline data 15 A table showing baseline demographic and clinical characteristics for each group Page 5-6
Numbers analysed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups Page 5-6
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) Page 5-6
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) -
Discussion Discussion Discussion Discussion
Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses Page 7-8
Generalisability 21 Generalisability (external validity, applicability) of the trial findings Page 6-7
Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence Page 6-7
Other information Other information Other information
Registration 23 Registration number and name of trial registry Page 5
Protocol 24 Where the full trial protocol can be accessed, if available Page 5
Funding 25 Sources of funding and other support (such as supply of drugs), role of funders -