0 to 2 | 1. Participants | Precise inclusion criteria for participants as well as settings and locations where data were collected | 2 | 1 | 2 |
| 2. Interventions | Precise details of the interventions intended for each group and how they were actually administered | 1 | 2 | 2 |
| 3. Sample size | Description of how sample size was determined and, when applicable, explanation of any interim analyses and stopping rules | 2 | 0 | 0 |
| 4. Randomization | Description of the method used to generate and implement the random allocation sequence including details of any restrictions (eg, blocking, stratification) | 2 | 0 | 2 |
| 5. Statistical methods | Explanation of statistical methods used to compare groups for primary outcomes | 2 | 2 | 2 |
| 6. Results | Description of flow of participants through each stage and of protocol deviations from study as planned, along with reasons | 1 | 2 | 2 |
| 7. Baseline data | Description of baseline demographic and clinical characteristics of each group | 2 | 1 | 1 |
| 8. Numbers analyzed | Precise number of participants (denominator) in each group included in each analysis and whether the analysis was by intention-to-treat | 2 | 2 | 2 |
| 9. Outcomes and estimates | Summary of results for each group for primary outcomes and precise description of estimated effect size | 1 | 2 | 2 |
| 10. Discussion | Comprehensive discussion of interpretation of results, taking into account study hypotheses and sources of potential bias or inaccuracy through discussion of limitations that affected findings | 1 | 2 | 2 |
0 to 4 | 11. Generalizability | Generalizability (external validity) of trial findings | 2 | 3 | 2 |
| 12. Overall evidence | General interpretation of results in the context of current evidence | 2 | 3 | 3 |
TOTAL | | | 20 | 20 | 22 |