Patients must be willing and have the capacity to sign the informed consent form. Exclusion Criteria: If any of the following apply, the patient MUST NOT enter the trial: 1. Have clinically significant cardiac disease, including: o Onset of unstable angina within 6 months of signing the Informed Consent Form (ICF). o Acute myocardial infarction within 6 months of the signing the ICF. o Known congestive heart failure (Grade III or IV as classified by the New York Heart Association); and/ or a known decreased cardiac ejection fraction (LVEF) of < 45%. o Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100 mmHg, despite optimal medical management. 2.