- Patient must not have poorly controlled hypertension (defined as systolic blood pressure of ≥ 140 mmHg or diastolic blood pressure of ≥ 90 mmHg). Initiation or adjustment of antihypertensive medications is permitted prior to study entry. Blood pressure must be re-assessed on two occasions that are separated by a minimum of one hour; on each of these occasions, the mean (of 3 readings) from each assessment must be < 140/90 mmHg for a patient to be eligible for this study.