Adverse event reporting and harms {22}
ADVERSE EVENT
All participants will be instructed during informed consent to report at any time any occurrence of AEs to the investigator. In addition, AEs will be solicited at every scheduled visit. The severity of AEs will be classified following the U.S. National Institutes of Health Common Terminology for Adverse Events 5.0 (CTCAE), available online at In this study, in order to prevent a false signal that might be due to a change in heart rate between assessments, a higher grade QTcF prolongation is defined as a combination of QTcF prolongation from baseline with an elevated absolute value, not a prolongation alone.
