Data management {19}
All protocol-required information collected during the trial must be entered by the investigator, or designated representative, in the eCRF. The investigator, or designated representative, should complete the eCRF pages as soon as possible after information is collected, preferably on the same day that a trial subject is seen for an examination, treatment or any other trial procedure. Any outstanding entries must be completed immediately after the final examination. An explanation should be given for all missing data. Further protocol deviations are explicitly asked for in the eCRF and have to be described by trial centres. The completed eCRF must be reviewed and signed by the investigator named in the trial protocol or by a designated sub-investigator.The IMBI is responsible for the data management within the trial. The study data will be collected and managed using REDCap (Research Electronic Data Capture) [