Interim analyses {21b}
COMPLICATIONS
Interim analysis will take place strictly for safety and ethical purposes. As soon as 20 patients per randomized group will be reached, data will be analyzed by the independent Data Safety Monitoring Board (DSMB). The trial will be stopped if the proportion of patients with major complications (Grade ≥ III) is statistically significantly higher (A second interim analysis will be conducted as soon as 50 per randomized group will be reached.Results of these security analyses will be known by the DSMB members only.