Table A2.

Part 2: CONSORT Items.

Section	Item No.	Checklist Item	Yes	No	Score
Title and Abstract	1a	Identification as a randomized trial in the title
	1b	Structured summary of trial design, methods, results, and conclusions
Background and objectives	2a	Scientific background and explanation of rationale
	2b	Specific objectives or hypotheses
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
Section	Item No.	Checklist Item	Yes	No	Score
Sample size	7a	How sample size was determined
	7b	When applicable, explanation of any interim analyses and stopping guidelines
Sequence generation	8a	Method used to generate the random allocation sequence
	8b	Type of randomization; 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
Participant flow	13a	For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome
	13b	For each group, losses and exclusions after randomization, together with reasons
	13c	Flow diagram
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
Limitations	20	Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses
Generalizability	21	Generalizability of the trial findings
Interpretation	22	Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence
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 role of funders