van den Berg, Paul
Ruppert, Martijn
Mesic, Emir
Snelder, Nelleke
Seelmann, Andreas
Heinig, Roland
Joseph, Amer
Garmann, Dirk
Lippert, Joerg
Eissing, Thomas http://orcid.org/0000-0003-4378-3423
Funding for this research was provided by:
Bayer
Article History
Accepted: 8 October 2021
First Online: 13 November 2021
Declarations
:
: LAP&P conducted the analysis as contract research for Bayer. However, LAP&P (PB, MR, EM, NS) was not paid to contribute to manuscript preparation.
: PB, MR, EM, are NS are employed by LAP&P, a CRO working for Bayer. AS, RH, AJ, DG, JL, and TE are Bayer employees and potential shareholders of Bayer AG.
: The study protocol was approved by international review boards, independent ethics committees, and competent authorities according to national and international regulations. FIDELIO-DKD was conducted in accordance with the ICH Harmonized Tripartite Guideline for Good Clinical Practice.
: All study participants provided written informed consent before entering the study.
: All study participants provided written informed consent before entering the study.
: Data will be made available in an electronic repository in future, at a date to be specified by Bayer.
: The NONMEM analysis code is provided as ESM.
: PB: wrote manuscript, designed research, performed popPK/TTE analysis, analyzed data; MR: wrote manuscript, performed TTE analysis, analyzed data; EM: wrote manuscript, performed popPK, analyzed data; NS: wrote manuscript, designed research, supported popPK/TTE analysis, analyzed data; AS: wrote manuscript, designed research, programmed and analyzed data; RH: wrote manuscript, designed research; AJ: wrote manuscript, designed research; DG: wrote manuscript, designed research; JL: wrote manuscript, designed research; TE: wrote manuscript, designed research, steered analysis, analyzed data.