13. Subject has clinically significant cardiac disease, including: 1) myocardial infarction within 1 year before study enrollment, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV); 2)uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities; 3) screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) >470 msec.