Kriván, Gergely
Borte, Michael
Soler-Palacin, Pere
Church, Joseph A.
Csurke, Ildiko
Harris, James B.
Lieberman, Jay A.
Melamed, Isaac R.
Moy, James N.
Simon, Reka
Aigner, Silke
Lentze, Stephan
Staiger, Christiane http://orcid.org/0000-0001-8687-7687
Article History
Received: 31 May 2022
Accepted: 26 October 2022
First Online: 16 November 2022
Declarations
:
: The clinical trial protocol (CSP), CSP amendments, informed consent form (ICF), investigator brochure, and other relevant documents (e.g., advertisements) were submitted to an independent ethics committee (IEC)/institutional review board (IRB) by the sponsor and reviewed and approved by the IEC/IRB before the trial was initiated.
: Subjects or their legally authorized representatives were required to sign a statement of informed consent that met local laws and regulations and ICH GCP guidelines, where applicable, and that was approved by the local IEC.
: The consent mentioned above included consent for publication of the trial results.
: Gergely Kriván was coordinating investigator of the trial and has received research grants from Biotest AG. Michael Borte, Pere Soler-Palacin, Joseph A. Church, Ildiko Csurke, James B. Harris, Jay A. Lieberman, Isaac R. Melamed, James N. Moy, and Reka Simon were principal investigators of children recruiting active sites. Silke Aigner, Stephan Lentze, and Christiane Staiger are employees of the trial sponsor Biotest AG, Dreieich, Germany.