Data will be collected by the use of paper CRF pages. Data entry will be performed at one central site that will maintain the overall database and will perform and be responsible for the data analysis. All the compiled CRFs will be archived. In order to eliminate possible data entry errors, individual data will be compared to a range of plausible values. After data entry, automated checks, that are defined beforehand (a priori), will be performed to evaluate internal inconsistencies, range errors, or missing data. For each atypical/out-of-range/missing data, a query will be automatically sent to the investigator. Once all the queries are solved, the database will be locked and used for statistical analysis.Statistical analysis will be performed in collaboration by the Department of Statistics of the University of Florence. Complete data will not be unblinded until the external medical and statistics review have been completed.