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Lowering the dose may blunt these protective advantages, especially in individuals with existing heart disease
Further, this Guidance did not address how this interplayed with the concept of anticipatory compounding by 503Bs for 503A, which the FDA has previously suggested can be done in a limited amount. Ultimately, this pathway carries its own risks
10.1016/j.celrep.2020.108421 153 ShiT.MaY.CaoL.ZhanS.XuY.FuF.et al (2019)
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