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The Merck court ruled that a defendant can prevail only if they prove they provided full justification to the FDA of a need for a label change, and the FDA informed the defendant they would not approve the labeling change

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But, we do have anecdotal safety data with some reports of research subjects experimenting with 1 mg 5 mg for several pulses, with no immediate negative health outcomes

Rushika Perera, Licia Selleri, Rolf Zeller, Andrei Goga, and Scott Oaks for their critical reading of the manuscript

Human microglia express roughly 50% fewer nanoparticle-targeting receptors, such as triggering receptors expressed on Myeloid cells 2 (TREM2), than rodent models, reducing cellular uptake [221]