Since no new therapy is offered as part of this study and no change in the patients' routine therapy is dictated by this protocol, only Serious Adverse Events potentially related to a procedure specifically requested (if any) by this natural history study will need to be reported to the Sponsor. However, all non-serious adverse events will be recorded in the natural history (observational) study CRF database, in order to be considered as a reference for the planned clinical trial to occur later on under a separate protocol.