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Further, one of the commenters stated that if Congress had intended to limit clotting factors to self-administered products in section 1861(s)(2)(I) of the Act, they could have used explicit language to that effect, as they did in section 1861(s)(2)(A) of the Act

A patient in perimenopause will not get the same duration as a twenty-eight-year-old on the same protocol, and that is normal physiology, not a failure of treatment