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Intranasal oxytocin for apathy in people with frontotemporal dementia (FOXY): a multicentre, randomised, double-blind, placebo-controlled, adaptive, crossover, phase 2a/2b superiority trial

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As proposed at 428.303(c)(5)(ii), a rebate reduction extension request and any new supporting documentation must be submitted at least 60 calendar days before the start of the second applicable period in which the manufacturer believes the generic Part D rebatable drug is likely to be in shortage in order for CMS to consider a rebate reduction extension