- A history of chronic disease including, but not limited to, unstable or uncontrolled hypertension (or been diagnosed with hypertension in the 6 months before Screening), sleep apnoea, cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal, haematological, urological, immunological or ophthalmic diseases that the Investigator believes are clinically significant e.g., unstable and could impact subject safety by participation in the study.