12 Primary, secondary, and other Done outcomes, including the specific measurement variable (eg, systolic blood pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation (eg, median, proportion), and time point for each outcome. Explanation of the clinical relevance of chosen efficacy and harm outcomes is strongly recommended 13 Time schedule of enrolment, Done interventions (including any timeline and washouts), assessments, and visits for participants. A schematic diagram is highly recommended (see Figure) Sample 14 Estimated number of participants Done size needed to achieve study objectives and how it was determined, including clinical and statistical assumptions supporting any sample size calculations 15 Strategies for achieving adequate Done participant enrolment to reach target sample size Methods: Assignment of interventions (for controlled trials) Done 16a Method of generating the allocation sequence (eg, computer-generated random numbers), and list of any factors for stratification. To reduce predictability of a random sequence, details of any planned restriction (eg, blocking) should be provided in a separate document that is unavailable to those who enrol participants or assign interventions
12 Primary, secondary, and other outcomes, including the specific measurement variable (eg, systolic blood pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation (eg, median, proportion), and time point for each outcome. Explanation of the clinical relevance of chosen efficacy and harm outcomes is strongly recommended Done timeline 13 Time schedule of enrolment, interventions (including any and washouts), assessments, and visits for participants. A schematic diagram is highly recommended (see Figure) Done Sample size 14 Estimated number of participants needed to achieve study objectives and how it was determined, including clinical and statistical assumptions supporting any sample size calculations Done 15 Strategies for achieving adequate participant enrolment to reach target sample size Done Methods: Assignment of interventions (for controlled trials) Done 16a Method of generating the allocation sequence (eg, computer-generated random numbers), and list of any factors for stratification. To reduce predictability of a random sequence, details of any planned restriction (eg, blocking) should be provided in a separate document that is unavailable to those who enrol participants or assign interventions
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