- For female patients, those who have been at their postmenopause at least for one year or longer, who have no potential to be pregnant by surgery or procedure, or who agreed to use acceptable contraceptive methods (intrauterine device [loop or Mirena], double barrier method [diaphragm or condom/femidom + spermicide], vasectomy in spouse, oral contraceptives or non-oral contraceptives) throughout the entire study period,Female patients whose pregnancy test at screening is positive in case of childbearing potential or breastfeeding women 15) History of malignant disease (excluding treated basal cell or squamous cell carcinoma of skin) within 5 years prior to Screening. Resolution of a prior malignancy more than 5 years prior to Screening must be deemed as cured by the investigator, 16) Patients who have history of taking or plan to take the following medications: