When a patient enters in the study the investigator assigned him a sequential Patient's Code, than the clinician sends Screening Form and Entry Form to the study registrar. The central registrar will match the randomization envelope with the subject number based on the randomization tables and he send the Registration Form, with the correspondence between Patient's Code and Treatment's Code. Following receipt of the registration form from the Central Registrar, the investigator will prescribe the treatment (Regenium or placebo) to the patient and will book all the subsequent appointments according to the protocol.