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Ardelyxs revamped New Drug Application included data from the Phase III PHREEDOM, BLOCK and AMPLIFY studies, all of which met their primary efficacy endpoints

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These procedures may include recording access dates, maintaining inventory logs, and monitoring storage conditions in accordance with internal quality standards

Specifically, and as further discussed later in this section, we proposed to require hospitals to report four new data elements when a payer-specific ( negotiated charge is based on a percentage or algorithmthe median allowed amount (which would replace the estimated allowed amount data element), the 10th percentile and 90th percentile allowed amounts, and the count of allowed amounts used to calculate the median, 10th, and 90th percentile allowed amounts