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The requirement to use a rolling average for lagged price concessions is codified at 414.804(a)(3), which states that, to the extent data on price concessions are available on a lagged basis, the manufacturer must estimate its ASP in accordance with the described methodology in that paragraph

When administered following clinical assessment and appropriate dosing, IV B-complex is generally well tolerated

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However, the current available antibody assay has low sensitivity and studies have found that antibodies are only detectable in 4060% of pernicious anaemia cases, so a negative test cannot categorically exclude pernicious anaemia[18,19]

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