 - Blood pressure BP and heart rate HR in semi-supine position at the Screening examination outside the ranges 90 to 140 mmHg systolic, 40 to 90 mmHg diastolic; HR 40 to 100 beatsmin. A subject with vital signs outside the reference range for the population being studied may be included at the Investigators discretion if it is unlikely to introduce additional risk factors and will not interfere with study procedures. 