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The applicant did not submit FDA-approved labeling for the drug for the adjuvant uses described in the application (further described below in this paragraph) due to ongoing cancer vaccine adjuvant trials

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For the first performance year in the current agreement period, the ACO's prepaid shared savings multiplier will be recalculated for changes in per capita shared savings or losses for the performance years that constitute BY1 or BY2 and that are used in the calculation of the prepaid shared savings multiplier as a result of issuance of a revised initial determination under 425.315

This preemptive step can help mitigate the dehydrating effects of alcohol