Figure 2

Quality report assessment of non-inferiority trials adapted from Le Henanff et al. [28]. 1. Report the margin and the justification for its choice 2. Appropriate sample size calculation 3. Report both on-treatment and intent-to-treat analysis for the primary endpoint 4. Report 1-sided or 2-sided confidence intervals of treatment difference 5. Conclusion 5.1 Conclude non-inferiority or equivalence only if both ITT and OT analyses permit that or provide separate conclusions. 5.2. Restate the prespecified margin in the abstract 5.3 Make interpretation according to the margin of equivalence or non-inferiority regarding of the primary endpoint 5.4 Conclude with standard and appropriate vocabulary in accordance with the aim and the results of the trial (ie, "non-inferior to" or "equivalent to").