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Because biological APIs are inherently labile, these stresses and environmental transitions introduce the risk of conformational change, aggregation between API molecules or API and excipient(s), and precipitation

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We also included an exception in this sixth criterion to allow us to use an alternative approach for Advanced APMs that do not base beneficiary attribution on any E/M services, and thus for which attributed beneficiaries are not a subset of the attribution-eligible beneficiary population based on the requirement to have at least one claim for an E/M service