The involved pharmaceutical company (AstraZeneca) will be notified of all SAEs, pregnancy, clinical relevant overdosing and adverse events of special interest (AESIs), if any. These events must be transmitted within 1 working day of the Investigator's awareness or identification of the event, using standardized forms. Reports will consist of patient identification (subject number, initials, sex, age), event (diagnosis), drug reporter identification (name, initials), causality and outcome and should be written in English. Results of any relevant complementary exams performed to obtain the final diagnosis of any SAE (e.g., hospital discharge summary, autopsy, consultation) will be made available to AstraZeneca entity upon request.