Any clinically relevant abnormality identified on the screening history and physical or laboratory examination or any other medical condition or circumstance making the volunteer unsuitable for participation in the study. Specific examples include, coronary artery disease, myocardial infarction, congestive heart failure, type 2 diabetes, renal disease and hypertension. If there is doubt on the appropriateness of a subject, that subject's eligibility for the study must be reviewed with the medical monitor prior to enrolment.