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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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A variety of superoxide dismutase mimetics have been synthesized that can be used as pharmaceutical agents for a wide variety of diseases in which native SOD is ineffective

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