Patients will be evaluated for inclusion in the study, and their personal data collected in a specific collection data notebook. After the informed consent procedure and if the patient consents to be included in the study, the centralized randomization assignment center will be contacted. When patient data are registered, the envelope will be opened and the strategy assigned to the patient reported to the investigator. The procedure shall be transcribed into a document contained in the envelope, signing and dating this register the person responsible at the central randomization center.