Monitoring for Adverse Events. At each visit, after the subject has had the opportunity to spontaneously mention any problems, the Investigator should inquire about AEs by asking the standard questions: • “Have you had any health problems since your last study visit?” • “Have there been any changes in the medicines you take since your last study visit?” Additionally, changes in any protocol-specific parameters and/or questionnaires evaluated during the study are to be reviewed by the Investigator. Any untoward (unfavorable and unintended) change in a protocol-specific parameter or questionnaire response that is clinically relevant, in the opinion of the Investigator, is to be reported as an AE. These clinically relevant changes will be reported regardless of causality.
Monitoring for Adverse Events. At each visit, after the subject has had the opportunity to spontaneously mention any problems, the Investigator should inquire about AEs by asking the standard questions: • “Have you had any health problems since your last study visit?” • “Have there been any changes in the medicines you take since your last study visit?”
