9. History or clinical evidence of adrenal disease (including Cushing's Syndrome or Addison's disease) or thyroid disease (including hyper or hypothyroidism), and/or previous clinically significant laboratory abnormalities of adrenal or thyroid function parameters. All subjects with thyroid function (TSH, FT4, FT3) outside the normal laboratory reference range at baseline and regarded by the Investigator as clinically significant.