Acknowledgements We thank the patients and their families, investigators, and staff from all the participating sites. The authors thank  Pranitha Akula  ( Novartis Healthcare Pvt Ltd. ) and  Manojkumar Patel  ( Novartis Healthcare PVT Ltd. ) for providing medical writing support, which was funded by  Novartis Pharmaceutical Corporation  in accordance with Good Publication Practice (GPP3) guidelines (http://www. ismpp. org/gpp3). The study protocol and all amendments were reviewed and approved (if applicable) by an independent ethics committee/institutional review board for each center:  National Hospital Organization Central Ethics Committee ;  Gazi University Clinical Research Ethics Committee ;  Independent Multidisciplinary Committee on Ethical Review of Clinical Trials; Peking Union Medical College Hospital; Commissie Medische Ethiek UZ Brussel; CNIL (Commission National de l'Informatique et des Libertés ),  CCTIRS (Comité Consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé );  Comité Etico Investigación Clínica de Euskadi (CEIC-E) ;  Consejeria de Salud y Bienestar Social, Dirección General de Calidad, Investigación, Desarrollo e Innovación, Comité Coordinador de Ética de la Investigación Biomédica de Andalucía; Research Ethics Committee of the University of Tartu (UT REC) ;  Ethikkommission der Medizinischen Universität Graz ;  North Wales REC-West ;  Regionala Etikprövningsnämnden i Göteborg ;  REK-Regionale komiteer for medisinsk og helsefaglig forskningsetikk; Komisja Bioetyczna przy Instytucie  " Pomnik Centrum Zdrowia Dziecka"; Ethikkommission bei der Ludwig-Maximilians-Universitat München ;  Hokkaido University Hospital Independent clinical research Institutional Ethics Committee ;  Medical Juntendo University Institutional Ethics Committee; National Center for Chile Health and Development of IRB; Osaka University Hospital of IRB; Ethics Committee at Moscow Institute of Pediatrics and Pediatric Surgery; Peking University First Hospital ;  Sanbo Brain Hospital Capital Medical University; Tianjin Children's Hospital; Childrens Hospital Of Fudan University ;  Zhongshan Hospital Fudan University ;  Fudan University Shanghai Cancer Center ; The  Second Affiliated Hospital of Guangzhou Medical University ; The First Affiliated Hospital,  Sun Yat-Sen University ; The  First Affiliated Hospital Of Guangzhou Medical University; Shenzhen Children's Hospital; West China Hospital, Sichuan University; Xijing Hospital; Children's Hospital of Chongqing Medical University; Wuhan Children's Hospital ; The  Second Affiliated Hospital of Xi 'an  Jiaotong University ;  Guangdong 999 Brain Hospital ;  Seoul National University Hospital Institutional Review Board ;  National Taiwan University Hospital (NTUH) Research Ethics Committee (REC) ;  Institutional Review Board  of the  Taichung Veterans General Hospital ;  Institutional Review Board  of  Chung Shan Medical University Hospital; Institutional Review Board, Tungs' Taichung MetroHarbor Hospital; Institutional Review Board of National Cheng Kung University Hospital ;  Metro South Human Research Ethics Committee; Sydney Children's Hospital Network Human Research Ethics Committee; St Vincent's Hospital Human Research Ethics Committee ;  Royal Melbourne Hospital Human Research Ethics Committee ;  Siriraj Institutional Review Board ; The Institutional Review board,  Faculty of Medicine, Chulalongkorn University , 3rd Floor,  Ananthamahidol Building ,  King Chulalongkorn Memorial Hospital ; The committee on Human Rights Related to Research Involving Human Subjects;  Institutional Review board, Royal Thai Army Medical Department IRB RTA, 5th Floor, Phramongkutklaowejvitya Building, Phramongkutklao College of Medicine; Research Ethics Committee, Faculty of Medicine, Chiang Mai University; Research and Development, Queen Sirikit National Institute of Child Health; Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town ;  Shaare Zedek Meidcla Center Helsinki committee; Sheba Medical Center Helsinki committee; Tel Aviv Sourasly Medical Center Helsinki committee; General University Hospital of Patras Ethics Committee; Pendeli Children's Hospital Ethics Committee ;  General University Hospital of Athens 'G.