Data management
SECONDARY
The data are entered into the eCRF by the clinician researchers in charge of the evaluation. A manual was written to guide the encoding. Double entries were made on the first patients. 100% of the primary and 10% of the secondary outcomes are verified by independent monitor of Antwerpen University Hospital Clinical Trial Centre (UZA CTC). Last checks for data values will be done by the statistician and the data manager of UZA CTC.