CONSORT 2010 checklist of information to include when reporting a randomised trial*

Section/Topic
Title and abstract 1a 1b Introduction #ac$ground and ob%ecti&es Methods !rial design +articipants Inter&entions Outcomes 2a 2b (a (b ,a ,b 5 /a /b 2a 2b 7a 7b : Identification as a randomised trial in the title Structured summary of trial design, methods, results, and conclusions Scientific bac$ground and e'planation of rationale Specific ob%ecti&es or hypotheses )escription of trial design (such as parallel, factorial" including allocation ratio Important changes to methods after trial commencement (such as eligibility criteria", *ith reasons -ligibility criteria for participants Settings and locations *here the data *ere collected !he inter&entions for each group *ith sufficient details to allo* replication, including ho* and *hen they *ere actually administered Completely defined pre.specified primary and secondary outcome measures, including ho* and *hen they *ere assessed 0ny changes to trial outcomes after the trial commenced, *ith reasons 3o* sample si1e *as determined 4hen applicable, e'planation of any interim analyses and stopping guidelines 8ethod used to generate the random allocation se6uence !ype of randomisation9 details of any restriction (such as bloc$ing and bloc$ si1e" 8echanism used to implement the random allocation se6uence (such as se6uentially numbered containers", describing any steps ta$en to conceal the se6uence until inter&entions *ere assigned 4ho generated the random allocation se6uence, *ho enrolled participants, and *ho assigned participants to inter&entions If done, *ho *as blinded after assignment to inter&entions (for e'ample, participants, care pro&iders, those
(for specific guidance see CONSO ! for abstracts"

Item No Checklist item

Reported on page No
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Sample si1e andomisation5 Se6uence generation 0llocation concealment mechanism Implementation #linding
CONSORT 2010 checklist

1; 11a

2.25( 2.25(.2.25,
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Statistical methods Results +articipant flo* (a diagram is strongly recommended" ecruitment #aseline data Numbers analysed Outcomes and estimation 0ncillary analyses 3arms Discussion >imitations ?eneralisability Interpretation Other information egistration +rotocol <unding

11b 12a 12b 1(a 1(b 1,a 1,b 15 1/ 12a 12b 17 1: 2; 21 22 2( 2, 25

assessing outcomes" and ho* If rele&ant, description of the similarity of inter&entions Statistical methods used to compare groups for primary and secondary outcomes 8ethods for additional analyses, such as subgroup analyses and ad%usted analyses <or each group, the numbers of participants *ho *ere randomly assigned, recei&ed intended treatment, and *ere analysed for the primary outcome <or each group, losses and e'clusions after randomisation, together *ith reasons )ates defining the periods of recruitment and follo*.up 4hy the trial ended or *as stopped 0 table sho*ing baseline demographic and clinical characteristics for each group <or each group, number of participants (denominator" included in each analysis and *hether the analysis *as by original assigned groups <or each primary and secondary outcome, results for each group, and the estimated effect si1e and its precision (such as :5= confidence inter&al" <or binary outcomes, presentation of both absolute and relati&e effect si1es is recommended esults of any other analyses performed, including subgroup analyses and ad%usted analyses, distinguishing pre.specified from e'ploratory 0ll important harms or unintended effects in each group (for specific guidance see CONSO ! for harms" !rial limitations, addressing sources of potential bias, imprecision, and, if rele&ant, multiplicity of analyses ?eneralisability (e'ternal &alidity, applicability" of the trial findings Interpretation consistent *ith results, balancing benefits and harms, and considering other rele&ant e&idence egistration number and name of trial registry 4here the full trial protocol can be accessed, if a&ailable Sources of funding and other support (such as supply of drugs", role of funders

2.25, . 2.25( 2.25( 2.25, 2.25( 2.25( 2.25, . 2.255 225/ . 2.257 2.252 2.252 2.252.2.257 . 2.25( 2.25(

*We strongly recommend reading this statement in conjunction with the CONSORT 2010 E !lanation and Ela"oration #or im!ortant clari#ications on all the items$ %# rele&ant' we also recommend reading CONSORT e tensions #or cluster randomised trials' non(in#eriority and e)ui&alence trials' non(!harmacological treatments' her"al inter&entions' and !ragmatic trials$ *dditional e tensions are #orthcoming+ #or those and #or u! to date re#erences rele&ant to this chec,list' see www$consort(statement$org$

CONSORT 2010 checklist

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