Clinically significant or uncontrolled cardiac disease. Serious co-morbid medical conditions, including clinically-significant cardiac disease Clinically significant cardiac disease. History of clinically significant cardiac disease; uncontrolled hypertension Clinically significant cardiac disease History of significant cardiac disease or uncontrolled hypertension History of significant cardiac disease, cardiac risk factors, or uncontrolled arrhythmias EXCLUSION CRITERIA FOR REGISTRATION: History of significant cardiac disease, cardiac risk factors, or uncontrolled arrhythmias Clinically significant cardiac disease. Clinically significant, uncontrolled heart disease and/or recent cardiac event (within months prior to randomization) Active or clinically significant cardiac disease. History of clinically significant or uncontrolled cardiac disease including but not limited to: Patients must not have clinically significant cardiac disease. Clinically significant cardiac disease Documented clinically significant cardiac arrhythmias Have a significant cardiac condition. Active or clinically significant cardiac disease clinically significant cardiac disease Subjects with clinically significant uncontrolled cardiac disease Clinically significant cardiac disease Evidence or history of significant cardiac disease (including evidence or history of significant cardiac disease (including myocardial infarction [MI] in the past months, significant cardiac arrhythmia, stage III or IV congestive heart failure [CHF]); cardiac stress test will be done as clinically indicated; (the specific test to be chosen at the discretion of the principal investigator [PI]) Patients who have a history of significant cardiac disease, cardiac disease risk factors or uncontrolled arrhythmias are NOT eligible for either Stratum History or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the study such as uncontrolled or significant cardiac disease Uncontrolled clinically significant cardiac arrhythmia Clinically significant or uncontrolled cardiac disease. Clinically significant cardiac disease History of clinically significant cardiac disease current, serious, clinically significant cardiac arrhythmias as determined by the Investigator. Clinically significant cardiac disease as per protocol-defined criteria. Have clinically significant cardiac disease Subjects with significant cardiac issues History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias Sustained or clinically significant cardiac arrhythmias Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, or clinically significant cardiac arrhythmias Significant history or risk of cardiac disease Has clinically significant cardiac disease History of clinically significant or uncontrolled cardiac, hepatic, or pulmonary disease Significant active cardiac disease within the previous months Significant active cardiac disease within the previous months prior to signing the ICF, including: Has clinically significant cardiac disease Clinically significant cardiac disease Clinically significant cardiac disease Significant active cardiac disease within the previous months from the signing of the ICD, including: Significant active cardiac disease within the previous months, including: Clinically significant, uncontrolled heart disease and/or recent cardiac repolarization abnormality including any of the following: Clinically significant active cardiac disease, uncontrolled heart disease and/or history of cardiac dysfunction including any of the following Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease, uncontrolled cardiac arrhythmia, or myocardial infarction within the last months); any history of clinically significant cardiac failure Active or clinically significant cardiac disease including: Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality Uncontrolled or significant cardiac disease Clinically significant or uncontrolled hypertension or cardiac disease Have clinically significant cardiac disease Clinically significant, uncontrolled heart disease and/or recent cardiac event within months prior to study No clinically significant cardiac conduction disorder on screening. History of clinically significant or uncontrolled cardiac disease. Significant cardiac disease within months Clinically significant valvular heart disease or uncontrollable high-risk cardiac arrhythmia Clinically significant cardiac disease as defined in the protocol Clinically significant cardiac disease Significant cardiac disease Evidence or history of significant cardiac disease Clinically significant cardiac disease Significant cardiac events History of clinically significant cardiac disease Clinically significant, uncontrolled heart disease and/or recent cardiac events. Clinically significant cardiac disease Clinically significant cardiac disease, including: Have clinically significant cardiac disease Clinically significant cardiac disease Uncontrolled systemic disease (e.g., clinically significant cardiac, pulmonary or metabolic disease) History of or evidence of clinically significant uncontrolled cardiac arrhythmias Known significant uncontrolled cardiac arrhythmias Significant history of cardiac disease History of clinically significant cardiac disease. Evidence of clinically significant cardiac abnormalities, uncontrolled hypotension, left ventricular ejection fraction below the lower limit of normal for the site or experience of significant cardiac interventional procedures. Significant history of cardiac disease Clinically significant cardiac disease; Significant active cardiac disease within the previous months: History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, or clinically significant cardiac arrhythmias Sustained or clinically significant cardiac arrhythmias Any clinically significant comorbidities, such as uncontrolled pulmonary disease, known impaired cardiac function or clinically significant cardiac disease (specified below), active CNS disease, active infection, or any other condition that could compromise the participant's participation in the study. Clinically significant cardiac disease Subjects with clinically significant uncontrolled cardiac disease Clinically significant cardiac or pulmonary disease Patients with any known significant cardiac abnormality. Any significant cardiac, hepatic or renal disease Significant active cardiac disease within the previous months, including: History of clinically significant or uncontrolled cardiac disease. Clinically significant cardiac disease within last months History of clinically significant or active cardiac disease History of significant cardiac disease or uncontrolled arrhythmias Clinically significant, uncontrolled heart disease and/or recent cardiac event (within months