| Study design |
Description of study design (e.g., parallel group comparison) |
| Study population |
Specification of inclusion and exclusion criteria for patients |
| Treatments |
Detailed account of treatments and their application in each intervention group and control group |
| Objectives |
Precise formulation of primary and secondary objectives/study questions |
| Endpoints |
Clear definition of primary and secondary endpoints |
| Sample size |
Description of how the required number of study participants was determined |
| Randomization |
Description of type of randomization of patients to treatment groups (e.g., stratified randomization) |
| Blinding |
Specification of degree of blinding (e.g., double blind) |
| Analysis population |
Number of patients analyzed in each treatment group and definition of population for analysis (e.g., ITT) |
| Results |
Presentation of the results for all primary and secondary endpoints for each treatment group |
| Adverse events |
Details of all major adverse events for each treatment group |
| Interpretation |
Interpretation of the results, taking into account the study question, possible causes of bias, the current state of knowledge, and other researchers’ publications on the same topic |
| Generalizability |
Discussion of the applicability of the study results to general patient care |
