Author Contributions: Dr Foell had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Foell, Frosch, Ravelli, Pistorio, Martini, Ruperto, Roth.
Acquisition of data: Foell, Wulffraat, Wedderburn, Wittkowski, Frosch, Stanevicha, Mihaylova, Ferriani, Tsakalidou, Foeldvari, Cuttica, Gonzalez, Ravelli, Khubchandani, Oliveira, Armbrust, Garay, Vojinovic, Norambuena, Gamir, García-Consuegra, Lepore, Susic, Corona, Dolezalova, Pistorio, Ruperto.
Analysis and interpretation of data: Foell, Wedderburn, Frosch, Gerß, Martini, Ruperto, Roth.
Drafting of the manuscript: Foell, Wulfraat, Wedderburn, Gerß, Martini, Ruperto, Roth.
Critical revision of the manuscript for important intellectual content: Foell, Wulffraat, Wedderburn, Wittkowski, Frosch, Gerß, Stanevicha, Mihaylova, Ferriani, Tsakalidou, Foeldvari, Cuttica, Gonzalez, Ravelli, Khubchandani, Oliveira, Armbrust, Garay, Vojinovic, Norambuena, Gamir, García-Consuegra, Lepore, Susic, Corona, Dolezalova, Pistorio, Martini, Ruperto, Roth.
Statistical analysis: Foell, Wittkowski, Gerß, Pistorio, Ruperto.
Obtained funding: Foell, Martini, Ruperto.
Administrative, technical, or material support: Foell, Wulffraat, Wedderburn, Frosch, Stanevicha, Mihaylova, Ferriani, Tsakalidou, Foeldvari, Cuttica, Gonzalez, Ravelli, Khubchandani, Oliveira, Armbrust, Garay, Vojinovic, Norambuena, Gamir, García-Consuegra, Lepore, Susic, Corona, Dolezalova, Pistorio, Ruperto, Roth.
Study supervision: Foell, Wulfraat, Wedderburn, Frosch, Gerß, Ruperto, Roth.
Financial Disclosures: None reported.
Funding/Support: The study was supported by grants from the non-for-profit organizations PRINTO and the “Deutsche Rheuma-Liga.” Wyeth Pharmaceuticals funded the patients' insurance in Germany.
Role of the Sponsor: This study was supported and approved by the PRINTO advisory council, which had no role in the study planning, design, management, or data analysis. The support of PRINTO covered personnel costs at the coordinating center for data collection, sample shipping costs, and an administrative reimbursement to all participating centers (€100 per patient enrolled).
Additional Contributions: We thank Simona Angioloni, BSA, Luca Villa, BSa, and Federica Penco, PhD, of the PRINTO coordinating center for excellent database development, overall management of the trial, and biological samples collection, and Melanie Saers, technician in the Department of Pediatrics, University of Muenster, Germany, for excellent technical assistance. We thank the clinical research nurses for help with data collection. We also acknowledge all remaining centers who enrolled patients in the trial: Argentina: M. T. Apaz, MD, Universidad Catolica, Cordoba; C. De Cunto, MD, Hospital Italiano de Buenos Aires, Buenos Aires; and R. Russo, MD, Hospital de Pediatria Juan P. Garrahan, Buenos Aires; Brazil: M. O. Hilario, MD, Universitade Federal de Sao Paolo, Sao Paolo; and C. S. Magalhães, MD, Hospital das Clínicas-Faculdade de Medicina de Botucatu, UNESP, Botucatu; Chile: A. Quezada, MD, Hospital Dr Exequiel Gonzalez Cortes, Santiago; Croatia: M. Harjacek, MD, Children's Hospital of Zagreb, Zagreb; Denmark: S. Nielsen, MD, Juliane Marie Centret, Rigshospitalet, København; France: R. Cimaz, MD, Ospedale A. Meyer, Firenze; S. Gandon-Laloum, MD, Chu Caen FEH, Caen; E. Grouteau, MD, Hôpital des enfants CHU Toulouse, Toulouse; and C. J. Deslandre, MD, Hôpital Saint Vincent de Paul, Paris; Georgia: M. Ioseliani, MD, M. Iashvili Children's Central Clinic, Tblisi; Germany: D. Moebius, MD, Carl-Thiem-Klinikum Cottbus, Cottbus; R. M. Kuester, MD, Rheumaklinik Bad Bramstedt, Bad Bramstedt; K. Minden, MD, Charite University Hospital Berlin, Berlin; and D. Holzinger, MD, University Childen's Hospital Muenster, Muenster; Hungary: Z. Balogh, MD, National Institute of Rheumatology and Physiotherapy (ORFI), Budapest; Israel: R. Brik, MD, Rambam Medical Center, Haifa; T. Tauber, MD, Asaf Harofe Medical Center, Zrifin; and Y. Uziel, MD, Haemek Hospital, Afula; Italy: R. Barcellona, MD, Azienda Sanitaria Provinciale 1 Agrigento/P.O. Ospedale Giovanni Paolo II di Sciacca, Sciacca (AG); S. Magni-Manzoni, MD, Fondazione IRCCS Policlinico S. Matteo, Pavia; S. Martino, MD, Clinica Pediatrica Universita’ di Torino, Torino; M. Masi, MD, Clinica Pediatrica Masi, Bologna; A. N. Olivieri, MD, Seconda Universita’ degli Studi di Napoli, Napoli; and A. Stabile, MD, Universita’ Cattolica del Sacro Cuore, Roma; Kuwait: K. Alsaeid, MD, Kuwait University, Safat; Mexico: R. Burgos-Vargas, MD, Servicio de Reumatologia, Hospital General de Mexico, Mexico City; Poland: H. Mazur-Zielinska, MD, Medical University of Silesia, Zabrze; Portugal: J. A. Melo-Gomes, MD, Instituto Portugues de Reumatologia, Lisbon; Russia: I. Nikishina, MD, Institute of Rheumatology RAMS, Moscow; Serbia: M. Jovanovic, MD, Institute of Child Health and Youth Health Care, Novi Sad; and S. Pasic, MD, Mother and Child Health Institute, Belgrade; Slovakia: R. Vesely, MD, Detska Fakultna Nemocnica, Kosice; Spain: J. Anton, MD, Hospital Sant Joan de Déu, Universitat de Barcelona, Esplugues (Barcelona); and M. J. Rua Elorduy, MD, Hospital de Cruces, Bilbao Vizcaya; Sweden: S. Hagelberg, MD, Karolinska University Hospital, Stockholm; Switzerland: T. Saurenmann, MD, Kinderspital Zuerich, Universitaetskinderklinik, Zurich; Turkey: E. Unsal, MD, Dokuz Eylul University Medical Faculty, Balcova, Izmir. Individuals enrolling patients received administrative reimbursement for their participating centers (€100 per patient enrolled). No other compensation was received by the individuals acknowledged.
This article was corrected online for typographical errors on 4/29/2010.