| Statistical methods | 12a | Statistical methods used to compare groups for primary and secondary outcomes | P6: Statistical Analysis |
| 12b | Methods for additional analyses, such as subgroup analyses and adjusted analyses | P7: Statistical Analysis | |
| Results | |||
| Participant flow (a diagram is strongly recommended) | 13a | For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome | P7: Demographics and Patients’ characteristics |
| 13b | For each group, losses and exclusions after randomisation, together with reasons | P7: Losses and exclusions after randomisation patient’s follow-up | |
| Recruitment | 14a | Dates defining the periods of recruitment and follow-up | P7: Losses and exclusions after randomisation patient’s follow-up |
| 14b | Why the trial ended or was stopped | P7: Losses and exclusions after randomisation patient’s follow-up | |
| Baseline data | 15 | A table showing baseline demographic and clinical characteristics for each group | Demographics and Patients’ characteristics |
| Numbers analysed | 16 | For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups | Demographics and Patients’ characteristics |
| Outcomes and estimation | 17a | For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) | P8: Survival end-points |
| 17b | For binary outcomes, presentation of both absolute and relative effect sizes is recommended | NA | |
| Ancillary analyses | 18 | Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory | P8: Survival end-points |
| Harms | 19 | All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) | P8, P9: Adverse Events |
| Discussion | |||
| Limitations | 20 | Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | NA |
| Generalisability | 21 | Generalisability (external validity, applicability) of the trial findings | P10: Paragraph 2 and 3 P11: Paragraph 1 |
| Interpretation | 22 | Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | P10: Paragraph 2 and 3 |
| Other information |
| ||
| Registration | 23 | Registration number and name of trial registry | P5: Paragraph 1 |
| Protocol | 24 | Where the full trial protocol can be accessed, if available | P5: Study design and treatment plan |
| Funding | 25 | Sources of funding and other support (such as supply of drugs), role of funders | NA |