Access to REDCap will be granted only to data collecting staff of participating centres, in accordance with the procedures outlined in the present protocol.

Each participating centre is granted access only to the patient data it has generated and recorded on the REDCap platform.

The data will be recorded using an encrypted data connection (HTTPS) in input masks via a web browser or mobile app.

In compliance with the EU General Data Protection Regulation, the Sponsor will sign a specific data transfer agreement with the database holder.

Any future migration of all data collected within the current web-based database system to another server or electronic data capture system (i.e., REDCap) will grant the same standards in terms of data security and privacy, and in no case, it will foresee a substantial change to the graphic interface and to the functionalities already known and used by the participating centres.