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In some embodiments, the otic formulation or composition comprises about 0.5% by weight of the poloxamer

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No, it is based on preclinical evidence and user practice rather than human clinical trials

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Liao Z, Zhang Z, Jin J, Ajani JA, Swisher SG , Stevens CW, Ho L, Smythe R, Vaporciyan AA, Putnam JB Jr, Walsh GL, Roth JA, Yao JC, Allen PK, Cox JD, Komaki R