CONSORT 2010

 1. Title and Abstract:

   - Identification as a randomized trial in the title.

   - Structured summary of trial design, methods, results, and conclusions.

2. Introduction - Background and Objectives:

   - Scientific background and explanation of rationale.

   - Specific objectives or hypotheses.

3. Methods - Trial Design:

   - Description of trial design (such as parallel, factorial) including allocation ratio.

4. Methods - Changes to Trial Design:

   - Changes to trial design after the trial commenced, with reasons.

5. Methods - Eligibility Criteria for Participants:

   - Eligibility criteria for participants and the settings and locations where the data were collected.

6. Methods - Interventions:

   - The interventions for each group with sufficient details to allow replication, including how and when they were actually administered.

7. Methods - Outcomes:

   - Clearly defined primary and secondary outcome measures and, when applicable, any changes after trial commencement, with reasons.

8. Methods - Participant Timeline:

   - Participant timeline (e.g., periods of recruitment, follow-up, and data collection).

9. Methods - Sample Size:

   - How sample size was determined and, when applicable, explanation of any interim analyses and stopping guidelines.

10. Methods - Randomization: Sequence Generation:

   - Method used to generate the random allocation sequence.

11. Methods - Randomization: Type:

   - Type of randomization; details of any restriction (e.g., blocking, stratification).

12. Methods - Randomization: Implementation:

   - Mechanism used to implement the random allocation sequence, ensuring that the sequence was concealed until participants were enrolled and assigned; who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions.

13. Methods - Blinding:

   - Whether participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment; if done, how the success of blinding was evaluated.

14. Methods - Statistical Methods:

   - Statistical methods used to compare groups for primary outcomes; methods for additional analyses, such as subgroup analyses.

15. Results - Participant Flow:

   - Flow of participants through each stage of the trial (diagram recommended), including numbers of participants randomly assigned, receiving intended treatment, completing the trial protocol, and analyzed for the primary outcome.

16. Results - Recruitment:

   - Dates defining the periods of recruitment and follow-up.

17. Results - Baseline Data:

   - Baseline demographic and clinical characteristics of each group.

18. Results - Numbers Analyzed:

   - Number of participants in each group included in each analysis and whether the analysis was by original assigned groups.

19. Results - Outcomes and Estimation:

   - For each primary and secondary outcome, results for each group, and the estimated effect size and its precision.

20. Results - Ancillary Analyses:

   - Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory.

21. Results - Harms:

   - All important harms or unintended effects in each group.

22. Discussion - Limitations:

   - Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses.

23. Discussion - Generalizability:

   - Generalizability (external validity) of the trial findings.

24. Discussion - Interpretation:

   - Interpretation consistent with results, balancing risks and benefits, and considering other relevant evidence.

25. Other Information - Registration:

   - Registration number and name of the trial registry.

26. Other Information - Protocol:

   - Where the full trial protocol can be accessed, if available.

27. Other Information - Funding:

   - Sources of funding and other support (such as supply of drugs), role of funders.