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The single human study mentioned in the review had significant limitations
( We did not receive public comments on the impact of ASM on small entities
Researchers must apply any institutional review protocols at their own discretion
Kruse T, Dahl K, Schaffer L, et al
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FDA lacks important information regarding any safety issues raised by KPV, including whether it would cause harm if administered to humans.18 In other words, there have been no dedicated safety studies on KPV, so its status as a safe or unsafe therapy is up in the air
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