 - Evidence of active or acute i.e. current, or recent within 4 weeks prior to registration diverticulitis, intra-abdominal abscess, gastrointestinal GI obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation; patients with abdominal carcinomatosis, a history of non-recent intra-abdominal abscess, or a history of non-recent GI obstruction should be evaluated for the potential need for additional treatment before coming on study 