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Among 141 mothers who provided milk samples, the median breastmilk vitamin B 12 level at 6 weeks postpartum was 136 pmol/L (184 ng/L) in the supplemented group and 87 pmol/L (118 ng/L) in the placebo group

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In some instances, upon administration of a controlled release auris formulation or composition described herein (e.g., a formulation comprising a therapeutic agent), drug concentrations relative to the binding constants of one or more otic receptors are relevant in determining a biologically meaningful PK profile or the minimum concentration of an active agent required for a therapeutic effect