Data Management Data specified in the trial protocol will be documented in the patient`s digital records. Additional clinical data are available from the electronic patient files. The investigating physician is responsible for appropriate completion of the form. The authors (AS, NS) are responsible for data base development, data acquisition, data storage, and validation. Data validation includes controls of completeness, consistence and plausibility of the data documented in electronic dossier using a query system between data management and investigating physician.