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were originally assigned (intentiontotreat* analysis), 15 (13%) excluded patients or did not analyze all patients as allocated Checklist of Items To Include When Reporting a Randomized Trial Title and Abstract ? How participants were allocated to interventions (., “random allocation,” “randomized,” or “randomly assigned”). Introduction ? Scientific background and explanation of rationale MethodsParticipants ? Eligibility criteria for participants ? The settings and locations where the data were collected Methods Interventions ? Precise details of the interventions intended for each group and how and when they were actually administered. Methods Objectives ? Specific objectives and hypotheses. Methods Outes ? Clearly defined primary and secondary oute measures. ? When applicable, any methods used to enhance the quality of measurements (., multiple observations, training of assessors). Methods Sample size ? How sample size was determined ? When applicable, explanation of any interim analyses and stopping rules. Methods Randomization ? Method used to generate the random allocation sequence ? Details of any restriction [of randomization] (., b