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Without human trials, clinicians cannot reliably determine appropriate dosing, long-term risks or whether benefits outweigh risks

doi: 10.1016/j.xcrm.2021.100424 104 SmolinskaABlanchetLCoulierLAmptKALuiderTHintzenRQet al

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But even today, more than three decades after BPC-157 was first synthesized, a grand total of three human studies have been conducted, and none of them were the kind of large-scale human trial thats typically part of the traditional drug-approval process