Who generated the random allocation sequence, who enrolled x participants, and who assigned participants to interventions§ Who was aware of intervention assignment after allocation (for example, x participants, providers, those assessing outcomes), and how any masking was done Statistical methods used to compare group outcomes x How missing data were handled, with details of any imputation method x Methods for additional analyses, such as subgroup analyses, adjusted n/a analyses, and process evaluations Results For each group, the numbers randomly assigned, receiving the intended x intervention, and analysed for the outcomes Where possible, the number approached, screened, and eligible prior to n/a random assignment, with reasons for non-enrolment For each group, losses and exclusions after randomisation, together with x reasons Dates defining the periods of recruitment and follow-up x Why the trial ended or was stopped x A table showing baseline characteristics for each group x Include socioeconomic variables where applicable x For each group, number included in each analysis and whether the x analysis was by original assigned groups§ For each outcome, results for each group, and the estimated effect size x and its precision (such as 95% confidence interval)§ Indicate availability of trial data x For binary outcomes, presentation of both absolute and relative effect x sizes is recommended Results of any other analyses performed, including subgroup analyses, x adjusted analyses, and process evaluations, distinguishing pre-specified from exploratory All important harms or unintended effects in each group (for specific n/a guidance, see CONSORT for Harms) Discussion Trial limitations, addressing sources of potential bias, imprecision, and, if x relevant, multiplicity of analyses Generalisability (external validity, applicability) of the trial findings x Interpretation consistent with results, balancing benefits and and x considering other relevant evidence
Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions§ x Who was aware of intervention assignment after allocation (for example, participants, providers, those assessing outcomes), and how any masking was done x Statistical methods used to compare group outcomes x How missing data were handled, with details of any imputation method x Methods for additional analyses, such as subgroup analyses, adjusted analyses, and process evaluations n/a Results For each group, the numbers randomly assigned, receiving the intended intervention, and analysed for the outcomes x Where possible, the number approached, screened, and eligible prior to random assignment, with reasons for non-enrolment n/a For each group, losses and exclusions after randomisation, together with reasons x Dates defining the periods of recruitment and follow-up x Why the trial ended or was stopped x A table showing baseline characteristics for each group x Include socioeconomic variables where applicable x For each group, number included in each analysis and whether the analysis was by original assigned groups§ x For each outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)§ x Indicate availability of trial data x For binary outcomes, presentation of both absolute and relative effect sizes is recommended x Results of any other analyses performed, including subgroup analyses, adjusted analyses, and process evaluations, distinguishing pre-specified from exploratory x All important harms or unintended effects in each group (for specific guidance, see CONSORT for Harms) n/a Discussion Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses x Generalisability (external validity, applicability) of the trial findings x Interpretation consistent with results, balancing benefits and and considering other relevant evidence x