- 60 Day prior therapy: has received any of the following within 60 days before Day 0: a) A non-biologic investigational agent (investigational agent applies to any drug not approved for sale in the country in which it is being used); b) Any new immunosuppressive/immunomodulatory agent; tacrolimus, Mycophenolate mofetil (MMF), and corticosteroids are permitted. Inhaled steroids and new topical immunosuppressive agents (e.g., eye drops, topical creams) are also allowed.