 - Past or present disease, which as judged by the investigator or medical monitor, may affect the outcome of this study or the subjects safety. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, gastrointestinal disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease with the exception of asthma, but including chronic bronchitis, emphysema, bronchiectasis or pulmonary fibrosis. 