Wolfson, Lara J.
Castillo, Marìa Esther
Giglio, Norberto
Mészner, Zsófia
Molnár, Zsuzsanna
Vàzquez, Mirella
Wysocki, Jacek
Altland, Alexandra
Kuter, Barbara J.
Stutz, Melissa
Rampakakis, Emmanouil
Roberts, Craig S.
Funding for this research was provided by:
Merck & Co., Inc. (Not applicable)
Article History
Received: 5 February 2019
Accepted: 29 May 2019
First Online: 26 June 2019
Ethics approval and consent to participate
: In line with the local regulations, notification to the central Ethics Committee was done for all participating sites. Approval was obtained from the following ethics committees: Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Centralna Ewidencja Badań Klinicznych [Poland]; Secretaría de Salud, Hospital del Niño Morelense, Dirección de División Médica, Dirección de Unidad de Enseñanza e Investigación, Comité de Investigación, Instituto Nacional de Pediatría, Hospital Médica Sur, Hospital de Especialidades del Niño y la Mujer, Hospital del Niño y el Adolescente Morelense, y el Centro de Investigación Farmacéutica Especializada [Mexico]; Ministerio de Salud, Instituto de Gestión de Servicios de Salud, Instituto Nacional de Salud del Niño – Breña [Peru]; Egészségügyi Tudományos Tanács Tudományos és Kutatásetikai Bizottság (ETT TUKEB), Egészségügyi Tudományos Tanács Titkárság [Hungary]; Institutional Review Board, Jordan University of Science and Technology, King Abdulla University Hospital [Jordan]; Ministerio de Salud - GCABA, Dirección General de Docencia e Investigación [Argentina]. Patient consent was not required, as data were collected retrospectively and provided by the treating physicians in an anonymous manner, identified only by an encrypted patient number.
: Not applicable.
: Dr. Wolfson is an employee and stockholder of Merck & Co. Dr. Castillo, Dr. Gilgio, Dr. Meszner, Dr. Vàsquez, Dr. Molnár, and Dr. Wysocki all report personal fees from Merck & Co. during the conduct of the study. In addition, Dr. Giglio reports personal fees from GSK outside of the submitted work; Dr. Mészner reports grants and personal fees from MSD, Pfizer, and GSK outside the submitted work; Dr. Wysocki reports grants from Sanofi during the conduct of the study, as well as grants and personal fees from Pfizer outside the submitted work. Ms. Altland, Dr. Kuter, and Dr. Roberts are employees of Merck & Co. Dr. Rampakakis reports ‘other’ conflict from Merck & Co., Inc., during the conduct of the study, and is an employee of JSS Medical Research, the CRO hired to manage the MARVEL studies and provide biostatistics and medical writing services. Ms. Stutz is an employee of JSS Medical Research.