Table 1.

Revised 2010 Consolidated Standards of Reporting Trials (CONSORT) Checklist

Section/Topic	Number	Description
Title and Abstract	1	Identification as a randomized trial in the title
	2	Has an abstract
	3	Has a structured summary
	4	Summary including trial design
	5	Summary including methods
	6	Summary including results
	7	Summary including conclusions
Introduction
Background and objectives	8	Scientific background
	9	Explanation of rationale
	10	Specific objectives or hypotheses
Methods
Trial design	11	Description of trial design (such as parallel, factorial)
	12	Description including allocation ratio
	13	Important changes to methods after trial commencement (such as eligibility criteria)
	14	Reasons for changes to methods after trial commencement
Participants	15	Eligibility criteria for participants
	16	Settings and locations where the data were collected
Intervention	17	States precise details of the interventions intended for each group about how to conduct the administration which could allow replication
	18	States precise details of the interventions intended for each group about when to conduct the administration which could allow replication
Outcomes	19	Defined what is the primary outcome measures
	20	Completely defined how the primary outcome measures were assessed
	21	Completely defined when the primary outcome measures were assessed
	22	Defined what is the secondary outcome measures
	23	Completely defined how the secondary outcome measures were assessed
	24	Completely defined when the secondary outcome measures were assessed
	25	Any changes to trial outcomes after the trial commenced
	26	Reasons of changes to trial outcomes after trial commenced
Sample size	27	How sample size was determined
	28	When applicable, any interim analyses
	29	Explanation of the interim analyses
	30	When applicable, any interim stopping guidelines
	31	Explanation of stopping guidelines relative with interim analyses.
Randomization
Sequence generation	32	Method to generate the random allocation sequence
	33	Types of randomization
	34	Details of any restriction for randomization (such as blocking and block size)
Allocation concealment mechanism	35	Mechanism used to implement the random allocation sequence (such as sequentially numbered containers)
	36	Describes any steps taken to concealed the sequence until interventions were assigned
Implementation	37	States who generated the allocation sequence
	38	States who enrolled participants?
	39	States who assigned participants to interventions (their trail groups)
Blinding	40	States that the trial is blinded or open.
	41	States how the trial is blinded
	42	States who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes)
	43	If relevant, description of the similarity of interventions
Statistical methods	44	Defines the statistical methods used in the trail
	45	Defines statistical methods used to compare groups for primary outcomes
	46	Defines statistical methods used to compare groups for secondary outcomes
	47	Methods for additional analyses, such as subgroup analyses and adjusted analyses
Results
Participant flow (a diagram is strongly recommended)	48	For each group, the numbers of participants who were randomly assigned
	49	For each group, the numbers of participants who received intended treatment
	50	For each group, the numbers of participants who were analyzed for the primary outcome
	51	For each group, losses and exclusions after randomization
	52	Reasons for losses and exclusions after randomization
Recruitment	53	Define the periods of recruitment
	54	Define the specific dates of recruitment
	55	Define the periods of follow-up
	56	Define the specific dates of follow-up
	57	Why the trial ended or was stopped
Baseline data	58	A table showing the baseline demographic and clinical characteristics for each group
Numbers analyzed	59	Actual number of participants in each group
	60	States whether the analysis was by original assigned groups
Outcomes and estimation	61	Summary of results for each group with primary outcomes
	62	Estimates effect size for primary outcomes
	63	Estimates precision of effect size (95 % confidence interval) for primary outcomes
	64	Summary of results for each group with secondary outcomes
	65	Estimates effect size for secondary outcomes
	66	Estimates precision of effect size (95 % confidence interval) for secondary outcomes
	67	For binary outcomes, presentation of both absolute and relative effect sizes is recommended
Ancillary analyses	68	Results of any other analyses performed, distinguishing prespecified from exploratory
	69	Results of subgroup analyses performed, distinguishing prespecified from exploratory
	70	Results of adjusted analyses performed, distinguishing prespecified from exploratory
Harms	71	All important harms or unintended effects in each group
Discussion
Limitations	72	Trial limitations
	73	Addressing sources of potential bias
	74	Addressing sources of imprecision
	75	If relevant, addressing source of multiplicity of analyses
Generalizability	76	Generalizability (external validity or applicability) of the trial findings
Interpretation	77	Interpretation of results
	78	Balancing benefits and harms
	79	Considering other relevant evidence relating with the results
Other Information
Registration	80	Registration number
	81	Name of trial registry
Protocol	82	Where the full trial protocol can be accessed, if available
Funding	83	Sources of funding and other support (such as supply of drugs)
	84	Role of funders