 All Adverse eventsAEs will be reported at the time of the visit or by telephone when it occurs. Those meeting the definition of Serious Adverse EventsSAEs must be reported using the SAE Form. Medical events that occur between the signing of the Informed Consent and the first intake of study drug will be documented in the medical history. Subjects should voluntarily report any AEs or in response to general, non-directed questioning. For each AE volunteered by the subject, the investigator will obtain all the information required to complete the AE page of the Case Report FormCRF, in accordance with the guidelines that accompany it. 