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Bacteriostatic Water for Injection, USP is: chemically designated H2O and is a sterile, non-pyrogenic preparation of water containing 0.9% (9mg/mL) of benzyl alcohol added as a preservative and has a pH of 5.7 (4.5 - 7.0)

The briefing materials also noted that it is unclear whether these AEs were attributable to BPC-157

Prucalopride was efficacious in relieving symptoms based on total Gastroparesis Cardinal Symptom Index, subscales of nausea/vomiting, fullness/satiety, and bloating/distention, as well as improvement in the overall Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life score ( Intravenously administered felcisetrag significantly accelerated gastric emptying, small bowel transit and colonic transit compared to placebo in patients with gastroparesis with previously confirmed delayed gastric emptying