When all pts have been completed (i.e. completion of follow-up 30 days post-surgery), all data have been entered into the database, and all queries solved, the Database Closure procedures will start. Decisions will be made how to classify pts into analysis populations, and how to handle protocol violations and deviating or missing data. All decisions will be dated and documented in a Database Closure document. After that the database will be locked. Any changes in the database thereafter will be documented.