 21. Has a Screening or Check-in Day -1 abnormal clinically significant CS ECG. Entry of any participant with an abnormal not clinically significant NCS ECG must be approved, and documented by signature of the principal investigator or medically qualified subinvestigator. In the case of a QT interval corrected using Fridericias formula QTcF interval greater than 450 millisecond msec or 480 msec participants with Bundle Branch Block or PR outside the range of 120 to 220 msec, assessment may be repeated once for eligibility determination at the Screening Visit andor Check-in Day -1 Visit. 