Published in Medicine and Law Weekly, September 1st, 2006
Earlier this year, Alliance applied to the Competent Authorities and to the Ethics Committees (equivalent to Investigational Review Board [IRB] in the U.S.) in France and Germany to proceed with the start of a phase II proof of concept clinical trial. The objective of the study will be to show the safety and demonstrate the efficacy of Oxygent to improve post-op gut function. The study is expected to enroll approximately 65 patients.
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