- Subject has a marked baseline prolongation of QT/QTc (Fridericia's formula) interval (e.g., repeated demonstration of a QTc interval >450 milliseconds (ms) as a guidance considering the patient's background of physiological conditions), or a history of additional risk factors for torsade de pointes (TdP, e.g., heart failure, hypokalemia, family history of Long QT Syndrome), or is using concomitant medications that prolong the QT/QTc interval.