Section/Topic	Item No	Checklist item	Reported on page No
Title and abstract
	1a	Identification as a randomised trial in the title	P1:Title
	1b	Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)	P1: Abstract
Introduction
Background and objectives	2a	Scientific background and explanation of rationale	P2, P3: Background
Background and objectives	2b	Specific objectives or hypotheses	P3: Background
Methods
Trial design	3a	Description of trial design (such as parallel, factorial) including allocation ratio	P5, Study design and treatment plan
Trial design	3b	Important changes to methods after trial commencement (such as eligibility criteria), with reasons	P5: Study design and treatment plan
Participants	4a	Eligibility criteria for participants	P4: Patients selection
Participants	4b	Settings and locations where the data were collected	P4: Patients selection
Interventions	5	The interventions for each group with sufficient details to allow replication, including how and when they were actually administered	P5: Study design and treatment plan
Outcomes	6a	Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed	P6: Statistical Analysis
Outcomes	6b	Any changes to trial outcomes after the trial commenced, with reasons	NA
Sample size	7a	How sample size was determined	P4: Sample size
Sample size	7b	When applicable, explanation of any interim analyses and stopping guidelines	NA
Randomisation:
Sequence generation	8a	Method used to generate the random allocation sequence	P5: Study design and treatment plan
Sequence generation	8b	Type of randomisation; details of any restriction (such as blocking and block size)	P5: Study design and treatment plan
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	P5: Study design and treatment plan
Implementation	10	Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions	P5: Study design and treatment plan
Blinding	11a	If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how	NA
Blinding	11b	If relevant, description of the similarity of interventions	NA