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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

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This addition targets systemic inflammation through NF-kB inhibition, fundamentally changing the therapeutic profile

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Long-term outcomes Do combinations provide sustained benefits beyond monotherapy over 1-2 year timeframes