Table 1.

CONSORT checklist [28]

Section / Topic	Checklist Item
Introduction
Background and objectives	Scientific background and explanation of rationale; specific objectives or hypotheses
Methods
Trial design	Description of trial design (such as parallel, factorial) including allocation ratio; important changes to methods after trial commencement (such as eligibility criteria), with reasons
Participants	Eligibility criteria for participants; settings and locations where the data were collected
Interventions	The interventions for each group with sufficient details to allow replication, including how and when they were actually administered
Outcomes	Completely defined pre-specified primary and secondary outcome measures, including how and when they were accessed; any changes to trial outcomes after the trial commenced, with reasons
Sample size	How sample size was determined; When applicable, explanation of any interim analyses and stopping guidelines
Random sequence generation	Method used to generate the random allocation sequence; type of randomization; details of any restriction (such as blocking and block size)
Allocation concealment mechanism	Mechanism used to implement the random allocation sequence (such as sequentially numbered containers)
Randomization implementation	Who generated the random allocation sequence, who enrolled the participants, and who assigned participants to interviews
Blinding	If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and; if relevant, description of the similarity of interventions
Statistical methods	Statistical methods used to compare groups for primary and secondary outcomes
Results
Participant flow diagram	For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome; for each group, losses and exclusions after randomization, together with reasons
Recruitment	Dates defining the periods of recruitment and follow-up
Baseline data	A table showing baseline demographic and clinical characteristics for each group
Numbers analyzed	For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned group
Outcomes and estimation	For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval); for binary outcomes, presentation of both absolute and relative effect sizes
Ancillary analyses	Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory
Harms	All important harms or unintended effects in each group (for specific guidance see CONSORT for harms (28)
Discussion
Limitations	Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses
Generalizability	Generalizability (external validity, applicability) of the trial findings
Interpretation	Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence
Other Information
Registration	Registration number and name of trial registry
Funding	Sources of funding and other support (such as supply of drugs); role of funders