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A standard reconstitution uses 12mL

Radiology 184:123130 Plecko B, Stoeckler-Ipsiroglu S, Schober E, Harrer G, Mlynarik V, Gruber S, Moser E, Moeslinger D, Silgoner H, Ipsiroglu O (2002) Oral &bgr;-hydroxybutyrate supplementation in two patients with hyperinsulinemic hypoglycemia: monitoring of &bgr;-hydroxybutyrate levels in blood and cerebrospinal fluid, and in the brain by in vivo magnetic resonance spectroscopy

It means the agency no longer has an active nomination designating dihexa as posing "significant safety concerns." That happened because the original nominator voluntarily withdrew their petition