Funding for this research was provided by:
Received: 10 September 2018
Accepted: 8 February 2019
First Online: 5 March 2019
Ethics approval and consent to participate
: The MONITOR-CKD5 study protocol was approved by the ethical review committees of participating centres in accordance with national laws and regulations. The central ethical review committees included Ethics Committee of the Ärztekammer Nordrhein (Düsseldorf, Germany), Ethics Committee of the Hospital-University Policlinico-Vittorio Emanuele of Catania (Catania, Italy), Independent Bioethics Committee for Scientific Research at GU Med (Gdańsk, Poland), National Agency for Medicines and Medical Devices (Bucuresti, Romania), Institute of Clinical Neurophysiology, Clinical Center Ljubljana (Ljubljana, Slovenia), Health Counseling General Secretary of Quality and Modernization, Autonomic Committee of Clinical Trials (Sevilla, Spain), and Cambridgeshire 1 Research Ethics Commitee (Cambridge, England); a complete list of all review boards including local ethical review committees is available as a supplementary online file (i.e., “Additional file InternalRef removed”). Written informed consent was obtained from all participating patients.
: Not applicable because this report does not contain data for individual patients.
: CC, JM, DG, FD, PZ, and GL received compensation from Hexal AG for their participation in the work reported here. AK is an employee of Hexal AG. KD, KM, and IA are affiliated with Matrix45; by company policy, they cannot hold equity in sponsor organizations and cannot receive direct personal benefits, financial or other, from sponsor organizations. Matrix45 provides similar services to other biopharmaceutical companies without exclusivity constraints.
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