2.8.7. Database Generation and Management
The database for statistical analysis was generated as follows:The database was compiled after the last test person had completed the study.Data from paper documentation (CRFs, questionnaires) were transferred to electronic files by two persons each (double data entry), and the files were compared for discrepancies.Discrepancies between entries were corrected.Then, the data bank was closed, and the data were transformed into an analysable form ready for statistical evaluation and unblinded.