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A major part of the systemic dose will form mixed disulphides together with serum albumin, while a minimal amount of the drug fractions will undergo hepatic metabolism to become disulphides

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The first criterion, at 419.66(c)(1), provides that CMS determines that a device to be included in the category is not appropriately described by any of the existing categories or by any category previously in effect and was not being paid for as an outpatient service as of December 31, 1996

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