Adherence to each CONSORT item
| CONSORT Item | n/N | % |
| 1a. Identification as a randomised trial in the title? | 222/394 | 56.3% |
| 1b. Structured summary of trial design, methods, results and conclusions? (See CONSORT for Abstracts) | 312/394 | 79.2% |
| 2a. Scientific background and explanation of rationale? | 392/394 | 99.5% |
| 2b. Specific objectives or hypotheses? | 389/394 | 98.7% |
| 3a. Description of trial design (such as parallel, factorial) including allocation ratio? | 110/394 | 27.9% |
| 4a. Eligibility criteria for participants? | 391/394 | 99.2% |
| 4b. Settings and locations where the data were collected? | 346/394 | 87.8% |
| 5. The interventions for each group with sufficient details to allow replication, including how and when they were actually administered? | 392/394 | 99.5% |
| 6a. Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed? | 212/394 | 53.8% |
| 7a. How sample size was determined? | 154/394 | 39.1% |
| 8a. Method used to generate the random allocation sequence? | 249/394 | 63.2% |
| 8b. Type of randomisation; details of any restriction (such as blocking and block size)? | 212/394 | 53.8% |
| 9. Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned? | 126/394 | 32.0% |
| 10. Who generated the random allocation sequence, who enrolled participants and who assigned participants to interventions? | 89/394 | 22.6% |
| 11a. If done, who was blinded after assignment to interventions (eg, participants, care providers, those CONSORT 2010 checklist Page 2 assessing outcomes) and how? | 128/394 | 32.5% |
| 12a. Statistical methods used to compare groups for primary and secondary outcomes? | 226/394 | 57.4% |
| 12b. Methods for additional analyses, such as subgroup analyses and adjusted analyses? | 158/394 | 40.1% |
| 13a. For each group, the numbers of participants who were randomly assigned, received intended treatment and were analysed for the primary outcome? | 303/394 | 76.9% |
| 13b. For each group, losses and exclusions after randomisation, together with reasons? | 282/394 | 71.6% |
| 14a. Dates defining the periods of recruitment and follow-up? | 171/394 | 43.4% |
| 15. A table showing baseline demographic and clinical characteristics for each group? | 342/394 | 86.8% |
| 16. For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups? | 302/394 | 76.6% |
| 17a. For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% CI)? | 192/394 | 48.7% |
| 18. Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory? | 152/394 | 38.6% |
| 19. All important harms or unintended effects in each group? (See CONSORT for Harms) | 133/394 | 33.8% |
| 20. Trial limitations, addressing sources of potential bias, imprecision and, if relevant, multiplicity of analyses? | 361/394 | 91.6% |
| 21. Generalisability (external validity, applicability) of the trial findings? | 237/394 | 60.2% |
| 22. Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence? | 393/394 | 99.7% |
| 23. Registration number and name of trial registry? | 176/394 | 44.7% |
| 24. Where the full trial protocol can be accessed, if available? | 35/394 | 8.9% |
| 25. Sources of funding and other support (such as supply of drugs), role of funders? | 386/394 | 98.0% |