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Severe GI disease

As an example, the applicant cited language from the Uretero1 TM decision in which CMS agreed that the device met the criterion for substantial clinical improvement, which stated that while comparative studies between Uretero1 TM and other disposable devices would be helpful, CMS agreed that the evidence demonstrating improved outcomes and reduced patient risk associated with the disposable device in comparison with reusable devices represented substantial clinical improvement (87 FR 71932)

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Individuals suffering from systemic stress due to chronic illness, trauma, or athletic over-training are often found to have low levels of GSH in their bodies

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First, the bioavailability and hepatic delivery of many dietary antioxidants (e.g., polyphenols, vitamins C and E) are often low and highly variable between individuals