8. Clinical evidence (including physical exam, ECG, laboratory tests) and review of the medical history) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study. The Hospital Anxiety and Depression Scale (HADS)33 will be used to exclude patients with significant affective disorders, as well as to determine anxiety and depression scores at the start of the study.