First Author's Name:

Manuscript Title:

Subheading

Description

TITLE

1. Identify the study as a randomized trial.

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ABSTRACT

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INTRODUCTION

3. State prospectively defined hypothesis, clinical objectives, and planned subgroup or covariate analyses.

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METHODS

Protocol

Describe

4. Planned study population, together with inclusion/exclusion criteria.

5. Planned interventions and their timing.

6. Primary and secondary outcome measure(s) and the minimum important difference(s), and how target sample size was projected.

7. Rationale and methods for statistical analyses, detailing main comparative analyses and whether they were completed on an intention-to-treat basis.

8. Prospectively defined stopping rules (if warranted).

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Assignment

Describe

9. Unit of randomization (e.g., individual, cluster, geographic).

10. Method used to generate the allocation schedule.

11. Method of allocation concealment and timing of assignment.

12. Method to separate the generator from the executor of assignment.

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Masking, blinding

13. Describe mechanism (e.g., capsules tables); similarity of treatment characteristics (e.g., appearance taste): allocation schedule control (location of code during trial and when broken) and evidence of successful: masking (blinding) among participants, person doing intervention, outcome accessors and data analysts.

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RESULTS

Participant Flow and follow-up

14. Provide a trial profile (see flow diagram - figure) summarizing participant flow, numbers and timing of randomization assignment, interventions, and measurements for each randomized group.

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Analysis

15. State estimated effect of intervention on primary and secondary outcome measures, including a point estimate and measure of precision (confidence interval).

16. State results in absolute numbers when feasible (e.g., 10/20, not 50%)

17. Present summary data and appropriate descriptive inferential statistics in sufficient detail to permit alternative analyses and replication.

18. Describe prognostic variables by treatment group and any attempt to adjust for them.

19. Describe protocol deviations from the study as planned, together with the reasons.

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COMMENT

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20. State specific interpretation of study findings, including sources of bias and imprecision (internal validity) and discussion of external validity, including appropriate quantitative measures when possible.

21. State general interpretation of the data in light of totality of the available evidence.

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*This checklist of 21 items is intended to assist authors, editors, and reviewers by ensuring that information pertinent to the trial is included in the study report.