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Sci Rep (2016) 6:20984

The FDA has enforcement authority over what gets listed but has historically exercised it lightly, a gap that regulators and courts have narrowed in recent years

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Caf-Au-Lait Macules Well-circumscribed, uniformly light to dark brown macules or patches that often range from 2 to 5 cm (in adults) Usually noted during infancy or early childhood Found in 1020% of the normal population but can serve as a marker of an underlying genodermatosis, especially when multiple Epidemiology In an individual, the number of caf-au-lait macules (CALMs) can vary from one to more than a dozen

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