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Authors
Goulooze, Sebastiaan Camiel
Snelder, Nelleke
Seelmann, Andreas
Horvat-Broecker, Andrea
Brinker, Meike
Joseph, Amer
Garmann, Dirk
Lippert, Joerg
Eissing, Thomas http://orcid.org/0000-0003-4378-3423
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Funding
Funding for this research was provided by:
Bayer
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Article History
Accepted: 8 October 2021
First Online: 17 November 2021
Declarations
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: Leiden Experts on Advanced Pharmacokinetics and Pharmacodynamics (LAP&P) conducted the analysis as contract research for Bayer. However, LAP&P (SCG, NS) were not paid to contribute to the manuscript preparation.
: SCG and NS are employed by LAP&P, a contract research organization working for Bayer. AS, AHB, MB, AJ, DG, JL, and TE are Bayer employees and potential shareholders of Bayer AG.
: Data will be made available in an electronic repository in future, at a date to be specified by Bayer.
: NONMEM analysis code is provided in the ESM.
: 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.
