 - Relevant history or current presence of any significant or unstable cardiovascular, respiratory, neurologic including seizures or significant cerebrovascular disease, renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease including history of neuroleptic malignant syndrome; History of any severe pre-existing gastrointestinal narrowing or inability to swallow oral study drug whole with the aid of water applies to those patients requiring oral tolerability only 