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Authors
de Vries, Petrus J. http://orcid.org/0000-0002-8915-1571
Belousova, Elena
Benedik, Mirjana P.
Carter, Tom
Cottin, Vincent
Curatolo, Paolo
D’Amato, Lisa
Beure d’Augères, Guillaume
Ferreira, José C.
Feucht, Martha
Fladrowski, Carla
Hertzberg, Christoph
Jozwiak, Sergiusz
Lawson, John A.
Macaya, Alfons
Marques, Ruben
Nabbout, Rima
O’Callaghan, Finbar
Qin, Jiong
Sander, Valentin
Sauter, Matthias
Shah, Seema
Takahashi, Yukitoshi
Touraine, Renaud
Youroukos, Sotiris
Zonnenberg, Bernard
Kingswood, J. Chris
Jansen, Anna C.
,
Shinohara, Nobuo
Horie, Shigeo
Kubota, Masaya
Tohyama, Jun
Imai, Katsumi
Kaneda, Mari
Kaneko, Hideo
Uchida, Yasushi
Kirino, Tomoko
Endo, Shoichi
Inoue, Yoshikazu
Uruno, Katsuhisa
Serdaroglu, Ayse
Yapici, Zuhal
Anlar, Banu
Altunbasak, Sakir
Lvova, Olga
Belyaev, Oleg Valeryevich
Agranovich, Oleg
Levitina, Elena Vladislavovna
Maksimova, Yulia Vladimirovna
Karas, Antonina
Jiang, Yuwu
Zou, Liping
Xu, Kaifeng
Zhang, Yushi
Luan, Guoming
Zhang, Yuqin
Wang, Yi
Jin, Meiling
Ye, Dingwei
Liao, Weiping
Zhou, Liemin
Liu, Jie
Liao, Jianxiang
Yan, Bo
Deng, Yanchun
Jiang, Li
Liu, Zhisheng
Huang, Shaoping
Li, Hua
Kim, Kijoong
Chen, Pei-Lung
Lee, Hsiu-Fen
Tsai, Jeng-Dau
Chi, Ching-Shiang
Huang, Chao-Ching
Riney, Kate
Yates, Deborah
Kwan, Patrick
Likasitwattanakul, Surachai
Nabangchang, Charcrin
Chomtho, Lunliya Thampratankul Krisnachai
Katanyuwong, Kamornwan
Sriudomkajorn, Somjit
Wilmshurst, Jo
Segel, Reeval
Gilboa, Tal
Tzadok, Michal
Fattal-Valevski, Aviva
Papathanasopoulos, Panagiotis
Papavasiliou, Antigone Syrigou
Giannakodimos, Stylianos
Gatzonis, Stylianos
Pavlou, Evangelos
Tzoufi, Meropi
Vergeer, A. M. H.
Dhooghe, Marc
Verhelst, Hélène
Roelens, Filip
Nassogne, Marie Cecile
Defresne, Pierre
De Waele, Liesbeth
Leroy, Patricia
Demonceau, Nathalie
Legros, Benjamin
Van Bogaert, Patrick
Ceulemans, Berten
Dom, Lina
Castelnau, Pierre
Martin, Anne De Saint
Riquet, Audrey
Milh, Mathieu
Cances, Claude
Pedespan, Jean-Michel
Ville, Dorothee
Roubertie, Agathe
Auvin, Stéphane
Berquin, Patrick
Richelme, Christian
Allaire, Catherine
Gueden, Sophie
Tich, Sylvie Nguyen The
Godet, Bertrand
Rojas, Maria Luz Ruiz Falco
Planas, Jaume Campistol
Bermejo, Antonio Martinez
Dura, Patricia Smeyers
Aparicio, Susana Roldan
Gonzalez, Maria Jesus Martinez
Pison, Javier Lopez
Barca, Manuel Oscar Blanco
Laso, Eduardo Lopez
Luengo, Olga Alonso
Rodriguez, Francisco Javier Aguirre
Dieguez, Ignacio Malaga
Salas, Ana Camacho
Carrera, Itxaso Marti
Salcedo, Eduardo Martinez
Petri, Maria Eugenia Yoldi
Candela, Ramon Cancho
da Conceicao Carrilho, Ines
Vieira, Jose Pedro
da Silva Oliveira Monteiro, José Paulo
de Oliveira Ferreira Leao, Miguel Jorge Santos
Luis, Catarina Sofia Marceano Ribeiro
Mendonca, Carla Pires
Endziniene, Milda
Strautmanis, Jurgis
Talvik, Inga
Canevini, Maria Paola
Gambardella, Antonio
Pruna, Dario
Buono, Salvatore
Fontana, Elena
Bernardina, Bernardo Dalla
Burloiu, Carmen
Cosma, Iuliu Stefan Bacos
Vintan, Mihaela Adela
Popescu, Laura
Zitterbart, Karel
Payerova, Jaroslava
Bratsky, Ladislav
Zilinska, Zuzana
Gruber-Sedlmayr, Ursula
Baumann, Matthias
Haberlandt, Edda
Rostasy, Kevin
Pataraia, Ekaterina
Elmslie, Frances
Johnston, Clare Ann
Crawford, Pamela
Uldall, Peter
Dahlin, Maria
Uvebrant, Paul
Rask, Olof
Bjoernvold, Marit
Brodtkorb, Eylert
Sloerdahl, Andreas
Solhoff, Ragnar
Jaatun, Martine Sofie Gilje
Mandera, Marek
Radzikowska, Elzbieta Janina
Wysocki, Mariusz
Fischereder, Michael
Kurlemann, Gerhard
Wilken, Bernd
Wiemer-Kruel, Adelheid
Budde, Klemens
Marquard, Klaus
Knuf, Markus
Hahn, Andreas
Hartmann, Hans
Merkenschlager, Andreas
Trollmann, Regina
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Funding
Funding for this research was provided by:
Novartis Pharma AG
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Article History
Received: 6 January 2020
Accepted: 30 July 2020
First Online: 1 September 2020
Ethics approval and consent to participate
: 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. Gennimatas Ethics Committee; Evaggelismos General Hospital Ethics Committee; General University Hospital of Thessaloniki “AHEPA” Ethics Committee; General University Hospital of Ionnina Ethics Committee; METC UMC Utrecht; Direcció General de Regulació, Planificació i Recursos Sanitaris; Comité Ético de Investigación Clínica del Hospital Universitario Vall d’Hebron de Barcelona, Generalitat de Catalunya. Departament de Salut; Comité Ético de Investigación Clínica Hospital Universitario La Paz; Dirección General de Ordenación e Inspección, Consejería de Sanidad Comunidad de Madrid, Servicios de Control Farmacéutico y Productos Sanitarios; Comité Etico Investigación Clínica del Hospital Universitario y Politécnico de La Fe; Dirección General de Farmàcia i Productes Sanitaris, Generalitat de Valencia; Comité de Ética de la Investigación de Centro de Granada; Instituto Aragonés de Ciencias de la Salud (IACS); Comité Etico Investigación Clínica Regional del Principado de Asturias; Comité Etico Investigación Clínica Hospital 12 de Octubre; Comité Etico Investigación Clínica Hospital Universitario Virgen de la Arrixaca; Sección de Ordenación e Inspección Farmacéutica Departamento de Salud; Comité Ético de Investigación Clínica del Hospital Universitario del Río Hortega de Valladolid; Comissão de Ética para a Saúde (CES), Centro Hospitalar de Lisboa Ocidental, EPE; Comissão de Ética para a Saúde (CES), Centro Hospitalar do Porto, E.P.E; Comissão de Ética para a Saúde (CES), Centro Hospitalar Lisboa Central, EPE; Comissão de Ética para a Saúde (CES), Hospital Garcia de Orta, EPE; Comissão de Ética para a Saúde (CES), Centro Hospitalar de São João, EPE; Comissão de Ética para a Saúde (CES), Hospital Professor Doutor Fernando Fonseca, EPE; Comissão de Ética para a Saúde (CES), Centro Hospitalar do Algarve, EPE (Unidade de Faro); LUHS Kaunas Regional Biomedical Research Ethics Committee; Paula Stradiņa klīniskās universitātes slimnīcas, Attīstības biedrības Klīniskās izpētes Ētikas komiteja, Ethics Committee for Clinical Research; Komisija Republike Slovenije za medicinsko etiko; Comitato Etico Indipendente Presso La Fondazione Ptv Policlinico Tor Vergata Di Roma; Comitato Etico Regione Calabria Sezione Centro c/o A.O.U. Mater Domini Di Catanzaro; Comitato Etico Azienda Ospedaliera Universitaria Di Cagliari; Comitato Etico Cardarelli-Santobono c/o Ao Cardarelli; Comitato Etico Per La Sperimentazione Clinica Delle Province Di Verona E Rovigo, Presso Aoui Verona; Eticka Komise Fn Brno; Eticka Komisia Dfnsp Bratislava; Eticka Komisia Pri Dfn Kosice; Eticka Komisia Bratislavskeho Samospravneho Kraja; Comisia Națională de Bioetică a Medicamentului și a Dispozitivelor Medicale; Comitato Etico Milano area 1 c/o ASST FBF Sacco - P.O. L. Sacco; Comité de Ética de la Investigación de Centro Hospital Universitario Virgen del Rocío; Comité Ético de Investigación Clínica Fundació Sant Joan de Déu Generalitat de Catalunya. Departament de Salut; Comité Ético de Investigación Clínica Hospital Infantil Universitario Niño Jesús; Consejería de Sanidad Dirección General de Salus Pública Junta de Castilla León; Dirección General de Asistencia Sanitaria, Consejería de Sanidad Gobierno del Principado de Asturias; Dirección General de Planificación, Ordenación Sanitaria y Farmacéutica e Investigación, Consejeria de Sanidad y Política Social Región de Murcia; Ethics Committee at Moscow Institute of Pediatrics and Pediatric Surgery; Paula Stradiņa klīniskās universitātes slimnīcas, Attīstības biedrības Klīniskās izpētes Ētikas komiteja, Ethics Committee for Clinical Research; The First Affiliated Hospital of The Fourth Military Medical University; Zhongshan Hospital Fudan University.
: Not applicable.
: PJdV, EB, TC, VC, PC, GBd’A, JCK, JCF, MF, CF, CH, SJ, RN, FO’C, JQ, MS, RT, JAL, AM, SY, MPB, BZ, and ACJ received honoraria and travel support from Novartis. VC received personal fees for consulting; lecture fees and travel from Actelion, Bayer, Biogen Idec, Boehringer Ingelheim, Gilead, GSK, MSD, Novartis, Pfizer, Roche, and Sanofi; grants from Actelion, Boehringer Ingelheim, GSK, Pfizer, and Roche; and personal fees for developing educational material from Boehringer Ingelheim and Roche. PJdV has been on the steering group of the EXIST-1, 2, and 3 studies sponsored by Novartis and co-PI on two investigator-initiated studies part-funded by Novartis. RN received grant support, paid to her institution, from Eisai and lecture fees from Nutricia, Eisai, Advicenne, and GW Pharma. YT received personal fees from Novartis for lecture and for copyright of referential figures from the journals and grant from the Japanese government for intractable epilepsy research. SJ was partly financed by the EC Seventh Framework Programme (FP7/2007-2013; EPISTOP, grant agreement no. 602391), the Polish Ministerial funds for science (years 2013–2018) for the implementation of international co-financed project, and the grant EPIMARKER of the Polish National Center for Research and Development No. STRATEGMED3/306306/4/2016. JCK, PC, CH, JAL, and JQ received research grants from Novartis. RM and SS are employees of Novartis. LD’A was an employee of Novartis at the time of manuscript concept approval. VS reported no conflict of interest.
