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Free base, acetate, hydration state, assay value, impurity profile, aggregation, and degradation can alter the composition of the tested material
Of the 130 patients, 126 completed the trial with 124 continuing to the open-label extended trial period
The CO-11 fix: replace D64.9 with D63.1 for CKD patients or D64.81 for chemo patients before resubmission, and include the hemoglobin value in the appeal documentation
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