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2 patients in placebo arms (Table 1A )

Section 419.66(f) states that a device is described by a category if, (1) it matches the long descriptor of the category code established by CMS, and (2) conforms to the guidance issued by CMS relating to the definition of terms and other information in conjunction with the category descriptors and codes

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Serum samples were prepared, and glucose concentration was determined using glucose oxidase