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With respect to the applicant's assertion that TERLIVAZ® significantly improves clinical outcomes, we note that the applicant provided evidence from data on file for the clinical study report of the CONFIRM trial that appear to consist of post-hoc analyses of patient subgroups, for example, improvement in renal function for patients with alcoholic hepatitis at baseline, and reduction in RTT requirements in patients who received a liver transplant
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Additionally, glutathione disulfide (GSSG) is involved in the degradation of drug delivery systems containing disulfide bonds, which allows for targeted drug release in cancer therapy
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