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Article History

Accepted: 1 December 2020

First Online: 24 January 2021

Declarations

:

: The underlying clinical studies were sponsored by Astellas (1517-CL-0613 and 1517-CL-0608) and AstraZeneca (D5470C00001 and D5470C00002).

: Dinko Rekić, Magnus Åstrand, and Mats Någård are employed by AstraZeneca. Virginie Kerbusch-Herben was contracted by Astellas, and Jiayin Huang and Stacey Tannenbaum are employed by Astellas. Charles Bradley and James Chou are employed by FibroGen. Bengt Hamrén is an employee of AstraZeneca and holds AstraZeneca shares.

: All studies were conducted in accordance with the US Code of Federal Regulations (CFR), Good Clinical Practice, 21 CFR Parts 50, 56, and 312, the ethical principles set forth in the Declaration of Helsinki, the International Conference on Harmonisation guideline regarding Good Clinical Practice (E6 Consolidated Guidance, April 1996), and the ethical requirements referred to in the European Union Directive 2001/20/EC. The study protocols were approved by the institutional review boards or ethics committees of the study sites.

: Informed consent was obtained from all individual participants included in the studies.

: Informed consent for publication was obtained from all individual participants included in the study.

: The datasets analyzed during the current study are available from AstraZeneca on reasonable request via the data request portal: .

: Model code is available from the authors upon request.

: DR designed and performed the research and drafted the manuscript. VKH, MN, JC, JH, CB, MÅ, ST, and BH designed the research and edited the manuscript.