 - Have any significant disease or disorder e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subjects ability to participate in the study 