Kneller, Lisa Alina
Zubiaur, Pablo
Koller, Dora
Abad-Santos, Francisco
Hempel, Georg http://orcid.org/0000-0002-5790-6423
Funding for this research was provided by:
H2020 Marie Skłodowska-Curie Actions (721236 grant)
Westfälische Wilhelms-Universität Münster
Article History
Accepted: 22 May 2021
First Online: 14 June 2021
Declarations
:
: Open Access funding enabled and organized by Projekt DEAL. Dora Koller and the multiple-dose phase I trial (EUDRA-CT: 2018-000744-26) were co-financed by the H2020 Marie Sklodowska-Curie Innovative Training Network 721236 grant.
: Lisa Alina Kneller, Pablo Zubiaur, Dora Koller, Francisco Abad-Santos, and Georg Hempel have no conflicts of interest that are directly relevant to the content of this article.
: All clinical trials were duly authorized by the Spanish Drugs Agency (AEMPS) and the Ethics Committee of Hospital Universitario de La Princesa, Madrid, Spain. They were carried out under the guidelines of Good Clinical Practices, complying with current Spanish legislation on clinical research in humans and with the Declaration of Helsinki. EUDRA-CT (ExternalRef removed) for single-dose clinical trials: 2012-004241-32, 2012-005274-60, 2012-002016-97, 2012-003196-19, 2013-002478-35, and 2013-002478-35. EUDRA-CT for multiple-dose phase I trial: 2018-000744-26 (ethics committee registry number: 3411)
: All subjects provided their informed consent for the present research.
: All authors provided their informed consent for publication.
: Data are available from the corresponding author upon reasonable request.
: Codes are available from the corresponding author upon reasonable request.
: Writing of the manuscript: LAK. Writing of the manuscript, review and editing: PZ, DK, FA-S, GH. Modeling and simulation: LAK, GH. Designed research: LAK, FA-S, GH. Determination of drug concentration: PZ, DK. Pharmacogenetics: PZ, DK.