Patients with postoperative fistulaXx_NEWLINE_xXNo history of gastrointestinal fistula or gastrointestinal perforation < 90 days of registrationXx_NEWLINE_xXHistory of gastrointestinal perforation; patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired or has healed, there has been no evidence of fistula for at least 6 months, and patient is deemed to be at low risk of recurrent fistulaXx_NEWLINE_xXHistory of gastrointestinal perforation; patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired or has healed, there has been no evidence of fistula for at least 6 months, and patient is deemed to be at low risk of recurrent fistulaXx_NEWLINE_xXAny history of gastrointestinal (GI) perforation, history of intra-abdominal abscess within 3 months prior to starting treatment, or history of abdominal fistula unless the fistula history meets all the following: (a) the fistula was surgically repaired, (b) there has been no evidence of fistula for at least 6 months prior to starting treatment, (c) patient is deemed to be at low risk of recurrent fistula, and (d) the case must be discussed with the study PIXx_NEWLINE_xXPatients with clinically significant gastrointestinal abnormalities including, but not limited to:* Clinically significant signs and/or symptoms of bowel obstruction within 3 months prior to starting treatment* History of intra-abdominal abscess within 3 months prior to starting treatment* History of gastrointestinal (GI) perforation within 6 months prior to starting treatment* Evidence of abdominal fistula within 6 months prior to starting treatment; history of abdominal fistula will be considered eligible if the fistula was surgically repaired, and there has been no evidence of fistula for at least 6 months prior to starting treatment, and patient is deemed to be at low risk of recurrent fistulaXx_NEWLINE_xXParticipants may not have had history of abdominal fistula or gastrointestinal perforation within the past 6 monthsXx_NEWLINE_xX