Table 2.
Main Exclusion Criteria
| Main prostate cancer exclusion criteria |
| Previous or current hormonal management of prostate cancer |
| Surgical castration |
| Any hormonal manipulation |
| Any previous neoadjuvant/adjuvant hormonal therapy, unless treatment terminated >12 months before study start |
| Main cardiovascular exclusion criteria |
| Uncontrolled type 1 or type 2 diabetes mellitus (defined as HbA1c >10%) at time of randomization |
| Uncontrolled hypertension (SBP >180 mm Hg or DBP >110 mm Hg) at time of randomization |
| A history of congenital long QT syndrome or risk factors for Torsade de pointes ventricular arrhythmias (e.g., heart failure, hypokalemia, concomitant medication known to cause QT prolongation) |
| Within 30 days before randomization: |
| Myocardial infarction |
| Stroke (hemorrhagic/ischemic) |
| Coronary, carotid, or peripheral artery revascularization |
| Planned or scheduled cardiac surgery or PCI procedure that is known at the time of randomization |
DBP = diastolic blood pressure; HbA1c = glycosylated hemoglobin A1c; PCI = percutaneous coronary intervention; SBP = systolic blood pressure.