[Open, non-comparative phase III clinical study to evaluate the efficacy and safety of sapropterin in patients with phenylketonuria and hyperphenylalaninemia].

T.V. Bushueva1, L.M. Kuzenkova1, T.E. Borovik1, L.P. Nazarenko2, G.N. Seitova2, M.N. Filimonova2, N.A. Pichkur3, N.V. Samonenko3, T.A. Shkurko3, E.N. Akhmadeeva4, A.K. Mardanova5, E.R. Garifullina5, O.P. Kovtun6, Y.L. Bazhenova6, I.L. Alimova7, E.A. Kostyakova7, L.I. Minaycheva2, O.A. Salyukova2, V.M. Sivokha2, O.L. Rozenson8 1 Scientific Center of Children Health, Moscow, Russian Federation 2 Research Institute of Medical Genetics, Tomsk, Russian Federation 3 National Children’s Hospital «Ohmatdyt», Kiev, Ukraine 4 Bashkir State Medical University, Ufa, Republic of Bashkortostan, Russian Federation 5 Republican Perinatal Centre, Ufa, Republic of Bashkortostan, Russian Federation 6 Ural State Medical University, Ekaterinburg, Russian Federation 7 Smolensk State Medical Academy, Russian Federation 8 LLC «Merck», Moscow, Russian Federation