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Footnotes
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Contributors Conception and design, acquisition of data or analysis and interpretation of data: SY, TI, MM (Masaaki Mori), TM (Takako Miyamae), ST, NI, HU, TM (Takuji Murata), MM (Mari Miyoshi), MT, NN, TK. Drafting the article or revising it critically for important intellectual content: SY. Final approval of the version to be published: SY, TI, MM (Masaaki Mori), TM (Takako Miyamae), ST, NI, HU, TM (Takuji Murata), MM (Mari Miyoshi), MT, NN, TK.
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Competing interests None.
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Ethics approval Protocols and amendments were approved by the Japanese Ministry of Health, Labour, and Welfare and the institutional review board of each centre. The parent or guardian of every child gave written informed consent, and the child gave assent when appropriate.
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Funding This study was sponsored by Chugai Pharmaceuticals Co, Ltd. Editorial support was provided by Genentech Inc, a member of the Roche group.
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Provenance and peer review Not commissioned; externally peer reviewed.
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Clinical Trial Registry Numbers: NCT00144599 and NCT00144612.