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The underlying premise, stated explicitly in FDA's own guidance, is that certain populations are "frequently underrepresented in biomedical research including in clinical studies, even when they have a disproportionate burden for certain conditions or diseases relative to their proportional representation" in the general population ( [19] )
* Daily Value not established
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Reconstitution Protocol When preparing the lyophilized powder for fluid-phase analysis, use a standard sterile bacteriostatic or sterile water medium
Draw 4.0 mL bacteriostatic water with a sterile syringe
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