Final version of the study protocol and study documentation

It includes the following documents, finalized according to the requirements of an international clinical study: 1) Protocol and protocol synopsis: the official final version of the study protocol (assumed a 100-page document); 2) Patient Information Sheet/Patient Informed Consent (PIS/PIC); 3) Letter to the General Practitioner; 4) Case Report Form (CRF): a Case Report Form (CRF); 5) Investigator’s Manual; 6) Translation of relevant documentation.