- Subject has a clinically significant abnormal 12-lead ECG that may jeopardize the subject's ability to complete the study or a Screening 12-lead ECG demonstrating any one of the following: heart rate > 100 beats per minute (bpm), QRS > 120 ms, QTc > 450 ms, or PR > 220 ms as determined by the investigator using the core laboratory ECG interpretation report.