Claeys, Carine
Drame, Mamadou
García-Sicilia, José
Zaman, Khalequ
Carmona, Alfonso
Tran, Phu My
Miranda, Mariano
Martinón-Torres, Federico
Thollot, Franck
Horn, Michael
Schwarz, Tino F.
Behre, Ulrich
Merino, José M.
Sadowska-Krawczenko, Iwona
Szymański, Henryk
Schu, Peter
Neumeier, Elisabeth
Li, Ping
Jain, Varsha K.
Innis, Bruce L.
Article History
Received: 6 September 2017
Accepted: 3 April 2018
First Online: 18 April 2018
Ethics approval and consent to participate
: All adults or a parent/guardian of children provided written informed consent for participation, and children were required to assent if capable. The study was conducted in accordance with the Good Clinical Practice guidelines, the Declaration of Helsinki and applicable local regulations. All study documents were approved by the appropriate Institutional Review Boards (Bangladesh: icddr,b; Czech Republic: Eticka komise Fakultni nemocnice Olomouc a Lekarske fakulty UP v Olomouci [68/14 MEK 9]; France: CPP SUD MEDITERANEE V [14.045]; Germany: Ethik-Kommission der Medizinischen Fakultät der Julius-Maximilians-Universität Würzburg [129/14 ff]; Poland: Komisja Bioetyczna przy Okregowej Izbie Lekarskiej; Spain: Comite Etico de Investigacion Clínica Area de Salud de Burgos y Soria; United States: Chesapeake IRB).
: Bruce L. Innis, Varsha K. Jain and Ping Li were employed by the GSK group of companies at the time of the study. Bruce L. Innis is currently employed by PATH. Varsha K. Jain is currently employed by the Bill and Melinda Gates Foundation. Ping Li is currently employed by Pfizer. Carine Claeys, Mamadou Drame, Peter Schu and Elisabeth Neumeier are employed by the GSK group of companies. Carine Claeys, Peter Schu, Elisabeth Neumeier, Ping Li, Varsha K. Jain, Bruce L. Innis hold shares in the GSK group of companies. Federico Martinón-Torres reports investigator fees to his institution from the GSK group of companies, during the conduct of the study; grants to his institution from the GSK group of companies, SPMSD, MERCK and PFIZER, as well as personal fees from PFIZER, outside the submitted work. Franck Thollot reports personal fees from the GSK group of companies, during the conduct of the study; personal fees from the GSK group of companies and non-financial support from Sanofi Aventis, outside the submitted work. Michael Horn reports personal fees from the GSK group of companies, during the conduct of the study. Tino F. Schwarz reports personal fees from the GSK group of companies, outside the submitted work. José M. Merino reports personal fees and non-financial support from the GSK group of companies, during the conduct of the study; personal fees from PFIZER and SANOFI-PASTEUR, outside the submitted work. José García-Sicilia reports fees to his institution from the GSK group of companies, during the conduct of the study. Khalequ Zaman, Alfonso Carmona, Phu My Tran, Mariano Miranda, Ulrich Behre, Iwona Sadowska-Krawczenko and Henryk Szymański declare no conflicts of interest.
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