- ECG abnormalities (clinically relevant), vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mnHg, diastolic blood pressure lower than 50 or over 90 mmHg or patient on any antihypertensive medication or heart rate less than 50 or over 100 bpm) or significant orthostatic hypotension (i.e.. a drop in systolic blood pressure of 30 mmHg or more and/or a drop in diastolic blood pressure of 20 mmHg or more on standing) at screening. Patients with vital signs values no more than 5% out of the specified range but considered stable could be included in the study at the discretion of the investigator.