Table. Checklist of Items To Include When Reporting a Randomized Trial Paper Section tem Deseiptor Reported on and Topic Number Page Number ‘The and abstact 1 How patlpants were allocated to interventions eg. “rancor allocation,” "randomized." or “rardermy srigned”) Intiedution Background 2 Scent background and explanation of raverale Methods Participant a ligt cers for patcpant ard the stings and lecatione where the date were collected Interventions 4 Drocie detcile ofthe intervention intended fr ech group and how and when they ‘were actualy edmiitered Obectves 5 Specie objectives and hypotheses Outcomes 6 ‘Cleat defined prrnary ad secondary outcome measures and, when appkcable, ary methods used to erfunce the qualty of measurements g. muliple observations, ttalnhg of ases09. Sample exe 7 How sample exe wie detemmined anc, when applicable, explanation of any terra “anaiyen and eeapping roe. Rendomization| ‘Sequence generation e ‘Method used to generate the ard allocation sequence, indludhg det of any reitiction (eg, blocking, vatfcation). ‘Aloceton concealment ° ‘Method used to mplement the random allocation sequence (eg, numbered centainets ‘or emia elephone), clviying whether the sequence was concealed unl interentors were asigia! Irplementation 10 ‘who generated the allocation sequence, who entoles partypants, and who assigned patipants to tel groups. ining (rast) " (Whether or not participants, those adrafistenng the nteventors, and thove asseningy the eutcomes wete blinded to group aeignrient If done, how the saccers oF blinding was evatstec, Statitcal methods 2 Statisteal wethoce used to compare group: for primary outcome(); methods for ‘acditonal analyses, such ac subgroup anelyse and adjusted anaiyces, Results Participant flow 8 Flow of parcibans through each stage (a dagram i stongly ‘ecommendes) ‘Specialy, foreach group repet the numbes of patkipants randomly asigred, receiving intended treatment, completing te study proce, and analyzed for the primary outcome: Descrbe protocol devations fom study as planned, together with Recruitment 14 Dates defining the perods of recrutment ard follow-up Baeane data 6 Escsine demographic and cine characterstes of each group, NNurnbers analyzed 16 "Number af partcpants(dencminaor in each greup included in each analyse and “whether the analyse was by “nferion to teat" Stts the recite in cbzoite rurmbors ven feasble (e.g, 10 of 20, not 50%) Outcomes and estrnaton 17 For each prmary ard secondary outcome, asrumary of rsuts foreach group end the cezivated cect ze and its preciion (eg. 95% confdence interval, Anclry anayses 18 ‘Adatessmulupety by eporung any other aralyses performed, incuding subgroup analyss and adjusted analyses incicatrg ose prespecia and those expbratory Adverse everts 1 Al mpomtant adverse everts or sde effec in each intervention Zup. Decusson Intrpretition 20 Interpretation of the reat, aking into account eudy hypatheres, sources of potential tite or mpreckion and the canger azocated wth mult of analyz coutzomes, Goneralzbility a Gorenaizabiity (tore valida) of tho tial findings. Overall evidence 2 (Geveral interpretation ofthe rests in the context f curent evidenceEnrollment Allocation Follow-up Analysis Assessed for eligibility (n = ¥ Excluded (n Did not meet inclusion criteria (n= mu) Refused to participate (n Other reasons (m=...) Randomized (n Allocated to intervention (n=) Received allocated intervention (7 = a) Did not receive allocated intervention (give reasons) (n=...) Allocated to intervention (n= ..) Received allocated intervention (7 = a) Did not receive allocated intervention (give reasons) (n=...) ¥ ¥ Lost to follow-up (n= (give reasons) Discontinued intervention (give reasons) (r=...) Lost to follow-up (n= (give reasons) Discontinued intervention (give reasons) (n= ..) Analyzed (rr Excluded from analysis (give reasons) (7 = a) Analyzed (a Excluded from analysis (give reasons) (n = «..)