 - Blood pressure BP and heart rate in semi-supine position at the Screening examination outside the ranges 90 mmHg to 140 mmHg systolic, 40 mmHg to 90 mmHg diastolic; heart rate 40 beatsmin to 100 beatsmin. Subjects with Stage 1 hypertension systolic 140 mmHg to 160 mmHg; diastolic 90 mmHg to 100 mmHg may be enrolled provided they do not have evidence of end-organ damage, diabetes or a 10 year cardiovascular risk 20. 