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10.1016/S0196-9781(98)00016-3

Hanioka et al

doi: 10.1177/13524585211016723 29 ChenTNotoDHoshinoYMizunoMMiyakeS

the drug is subject to an open drug efficacy study, health care professionals rely on the drug to treat serious medical conditions when there is no FDA-approved drug to treat the condition, and there is insufficient supply of an FDA-approved drug