Table 3.

CONSORT statement for each study

Section/topic	No	Checklist item	Huang	Righesso	Teli	Garg
Title/abstract	1a	Identification as a randomised trial in the title	Yes	Yes	No	Yes
	1b	Structured summary of trial design, methods, results, and conclusions	No	Yes	No	Yes
Introduction
Background/objectives	2a	Scientific background and explanation of rationale	Yes	Yes	Yes	Partly
	2b	Specific objectives or hypotheses	Partly	No	Yes	No
Methods
Trial design	3a	Description of trial design (such as parallel, factorial) including allocation ratio	Yes	No	No	No
	3b	Important changes to methods after trial commencement (such as eligibility criteria), with reasons	No	No	No	No
Participants	4a	Eligibility criteria for participants	Yes	Yes	Yes	Yes
	4b	Settings and locations where the data were collected	No	No	Yes	No
Interventions	5	The interventions for each group with sufficient details to allow replication, including how and when they were actually administered	No	No	Yes	No
Outcomes	6a	Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed		No	Yes	No
	6b	Any changes to trial outcomes after the trial commenced, with reasons		–	–	–
Sample size	7a	How sample size was determined	No	No	Yes	No
	7b	When applicable, explanation of any interim analyses and stopping guidelines		No	No	No
Randomisation: sequence	8a	Method used to generate the random allocation sequence	No	No	Yes	No
Generation	8b	Type of randomisation; details of any restriction (such as blocking and block size)	No	No	No	No
Allocation concealment	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	No	No	No	No
Implementation	10	Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions	No	No	No	No
Blinding	11a	If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how	No	No	Yes	No
	11b	If relevant, description of the similarity of interventions	No	–	–	–
Statistical methods	12a	Statistical methods used to compare groups for primary and secondary outcomes	Yes	Yes	Yes	Yes
	12b	Methods for additional analyses, such as subgroup analyses and adjusted analyses	No	No	No	No
Results
Participants flow	13a	For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome	No	No	Yes	No
	13b	For each group, losses and exclusions after randomisation, together with reasons	Yes	No	Yes	No
Recruitment	14a	Dates defining the periods of recruitment and follow-up	No	Yes	Yes	Yes
	14b	Why the trial ended or was stopped	No	No	Yes	No
Baseline data	15	A table showing baseline demographic and clinical characteristics for each group	No	Yes	Yes	Yes
Numbers analysed	16	For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups	Yes	Yes	Yes	Yes
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)	Yes	No	Yes	No
	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	No	No	No	No
Harms	19	All important harms or unintended effects in each group	Yes	Yes	Partly	Yes
Discussion
Limitations	20	Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses	No	No	No	No
Generalisability	21	Generalisability (external validity, applicability) of the trial findings	No	No	No	No
Interpretation	22	Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence	Yes	Partly	No	Yes
Other information
Registration	23	Registration number and name of trial registry	No	No	No	No
Protocol	24	Where the full trial protocol can be accessed, if available	No	No	No	No
Funding	25	Sources of funding and other support (such as supply of drugs), role of funders	Yes	No	No	No