Populations for analysis
SECONDARY
The primary analysis data set is the intention-to-treat population. This data set contains all the patients who have been enrolled in the clinical trial and randomized.The secondary analysis data set is derived from the per-protocol population. This data set includes all patients who have been treated according to the protocol during the whole duration of the study and reached a defined endpoint.The tertiary analysis data set (safety-population) contains all the patients who have received the trial procedure.