TU-100 for Accelerating GI Recovery After Major Abdominopelvic Surgery (RC & CAWR)

Subjects will be screened for eligibility up to 28 days before their planned RC or CAWRsurgery and will be randomized 1:1 (TU‐100 7.5 g/day: placebo) on postoperative Day 1before the first dose of study medication. After randomization, subjects will receiveTU‐100 7.5 g/day or matching placebo (3 times per day (TID)) until hospital discharge or≤ 10 days (whichever is earlier). All subjects will be treated with study medication asadjunctive to an Enhanced Recovery After Surgery (ERAS) pathway for gastrointestinalrecovery. The primary objective of the study is to compare the effect of TU‐100 withplacebo, in conjunction with and ERAS pathway, on the proportion of subjects achievingconfirmed upper and lower GI recovery (GIR) following major abdominopelvic surgeryrequiring extensive manipulation and/or resection of the bowel.