Table 1.

The Extraction Criteria According to the CONSORT 2010 Checklist

Section/Topic	Item No.	Checklist item
Title and abstract
	1	Identification as a randomized trial in the title
	2	Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)
Introduction
Background and objectives	3	Scientific background and explanation of rationale
	4	Specific objectives or hypotheses
Methods
Trial design	5	Description of trial design (such as parallel, factorial) including allocation ratio
	6	Important changes to methods after trial commencement (such as eligibility criteria), with reasons
Participants	7	Eligibility criteria for participants
	8	Settings and locations where the data were collected
Interventions	9	The interventions for each group with sufficient details to allow replication, including how and when they were actually administered
Outcomes	10	Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed
	11	Any changes to trial outcomes after the trial commenced, with reasons
Sample size	12	How sample size was determined
	13	When applicable, explanation of any interim analyses and stopping guidelines
Randomization:
Sequence generation	14	Method used to generate the random allocation sequence
	15	Type of randomization; details of any restriction (such as blocking and block size)
Allocation concealment mechanism	16	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	17	Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions
Blinding	18	If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how
	19	If relevant, description of the similarity of interventions
Statistical methods	20	Statistical methods used to compare groups for primary and secondary outcomes
	21	Methods for additional analyses, such as subgroup analyses and adjusted analyses
Results
Participant flow (a diagram is strongly recommended)	22	For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome
	23	For each group, losses and exclusions after randomization, together with reasons
Recruitment	24	Dates defining the periods of recruitment and follow-up
	25	Why the trial ended or was stopped
Baseline data	26	A table showing baseline demographic and clinical characteristics for each group
Numbers analysed	27	For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups
Outcomes and estimation	28	For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)
	29	For binary outcomes, presentation of both absolute and relative effect sizes is recommended
Ancillary analyses	30	Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory
Harms	31	All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)
Discussion
Limitations	32	Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses
Generalizability	33	Generalizability (external validity, applicability) of the trial findings
Interpretation	34	Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence
Other information
Registration	35	Registration number and name of trial registry
Protocol	36	Where the full trial protocol can be accessed, if available
Funding	37	Sources of funding and other support (such as supply of drugs), role of funders