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Investigators from the US, Canada, and Europe participated in an industry-sponsored phase III, multicenter, randomized, double-blind, placebo-controlled trial to determine the efficacy of sapropterin in lowering the levels of blood phenylalanine in individuals with phenylketonuria (PKU). The study population consisted of 89 screened patients with PKU who had relaxed or abandoned a strict low-phenylalanine diet and who had participated in a previous phase I study of sapropterin. Eligibility criteria included responsiveness to sapropterin in the previous study, which was defined as a reduction of 30% or more in blood phenylalanine concentration after eight days of treatment with sapropterin; blood phenylalanine of 600 μmol/L or greater …
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