only referred to elevated hepatic enzymes or hepatitis. PROCEDURES FOR ELICITING, RECORDING, AND REPORTING ADVERSE EVENTS Eliciting Adverse Events A consistent methodology for eliciting AEs at all subject evaluation timepoints should be adopted. Examples of non-directive questions include: “How have you felt since your last clinical visit?” “Have you had any new or changed health problems since you were last here?” Specific Instructions for Recording Adverse Events Investigators should use correct medical terminology/concepts when reporting AEs or SAEs. Avoid colloquialisms and abbreviations.