Study concept and design: Bakris, Chan, Gansevoort, Haller, Remuzzi, Schmieder, Nowack, Kolkhof, Joseph, Ruilope.
Acquisition, analysis, or interpretation of data: Agarwal, Chan, Cooper, Gansevoort, Rossing, Nowack, Kolkhof, Joseph, Pieper, Kimmeskamp-Kirschbaum.
Drafting of the manuscript: Bakris, Chan, Cooper, Nowack, Kolkhof, Joseph, Ruilope.
Critical revision of the manuscript for important intellectual content: Bakris, Agarwal, Chan, Cooper, Gansevoort, Haller, Remuzzi, Rossing, Schmieder, Nowack, Kolkhof, Joseph, Pieper, Kimmeskamp-Kirschbaum.
Statistical analysis: Gansevoort, Nowack, Pieper, Kimmeskamp-Kirschbaum.
Obtained funding: Nowack.
Administrative, technical, or material support: Bakris, Cooper, Gansevoort, Haller, Nowack, Joseph.
Study supervision: Bakris, Chan, Schmieder, Nowack, Ruilope.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Bakris has received an investigator-initiated grant/research support from Takeda (direct funding to University of Chicago); has been a principal investigator in national/international clinical trials sponsored by Bayer HealthCare AG, Medtronic, and Relypsa (direct funding to University of Chicago); and has been an advisor/consultant for AbbVie, Bayer HealthCare AG, Bristol-Myers Squibb, CVRx, Elcelyx, Eli Lilly/Boehringer Ingelheim, Janssen, Medtronic, Novartis GlaxoSmithKline, Takeda, Tengion, and ZS Pharma. Dr Agarwal has participated in steering committees for AbbVie, Bayer HealthCare AG, and Sandoz; has performed data safety monitoring for Amgen and Celgene; has been a consultant to AstraZeneca, Daiichi Sankyo, Genkyotex, Eli Lilly, and Takeda; and has received grant and research funding from the US Department of Veterans Affairs and the National Institutes of Health. Dr Chan is a member of steering committees of international projects funded by AstraZeneca, Bayer HealthCare AG, Eli Lilly, Merck Sharp & Dohme, Pfizer, and Sanofi; is a member of global/regional advisory boards of Boehringer Ingelheim, Eli Lilly, Merck Sharp & Dohme, and Pfizer; and has received an honorariaum and travel support from Amylin, AstraZeneca, Bayer HealthCare AG, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, GlaxoSmithKline, Impeto, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Sanofi, and Takeda, with the honorarium donated to the Chinese University of Hong Kong for diabetes research and education. Dr Cooper has received grants and lecture fees from Novo Nordisk, AbbVie, Boehringer Ingelheim, Eli Lilly, Bayer HealthCare AG, Merck Sharp & Dohme, and AstraZeneca. Dr Gansevoort has consultancy agreements with AbbVie, Bayer HealthCare AG, Ipsen, Novartis Pharma, and Otsuka Pharmaceuticals (no personal remuneration is accepted; compensations are paid to his institution for research. Drs Haller and Schmieder have received honoraria for presentations from Bayer HealthCare AG. Dr Remuzzi has consultancy agreements with Alexion Pharmaceuticals, Bayer HealthCare AG, Novartis Pharma, and REATA Pharmaceuticals (no personal remuneration is accepted; compensations are paid to his institution for research and educational activities). Dr Rossing has consultancy agreements with AbbVie, AstraZeneca, Bayer HealthCare AG, Bristol-Myers Squibb, Eli Lilly, Boehringer Ingelheim, Novartis Pharma, and Novo Nordisk (no personal remuneration is accepted; compensations are paid to his institution) and has shares in Novo Nordisk AS. Mr Pieper provided clinical trial support funded by Bayer HealthCare AG. Dr Ruilope has been a speaker and advisor for Bayer HealthCare AG. No other disclosures are reported.
Group Information:Australia: Kevan Polkinghorne, Lawrence McMachon, David Packham, Rowan Walker, Eugenia Pedagogos, Nicole Isbel, Carol Pollock. Austria: Gere Sunder-Plassmann, Christoph Schnack, Rudolf Prager, Peter Balcke, Alexander Rosenkranz, Bernhard Paulweber, Raimund Weitgasser, Gert Mayer. Bulgaria: Natali Temelkova, Boyan Nonchev, Svetla Vasileva, Zhulieta Prakova, Rosen Rashkov, Kiril Hristozov, Neli Klyuchkova, Volen Slavyanov. Canada: Stephen Chow, Robert Ting, Vincent Pichette, Thomas Elliott, Andrew Steele, Simon Desmeules, Sheldon Tobe, Shivinder Jolly, Hugh Tildesley. CzechRepublic: Terezie Pelikanova, Michaela Pelikanova, Jiri Hradec, Martin Prazny, Borek Lacnak. Germany: Frank Dellanna, Christian Kasperk, Thomas Behnke, Kirsten Reschke, Lutz StemLer, Herman Haller, Diethelm Tschope. Denmark: Per Poulsen, Erling Pedersen, Ole Rasmussen, Peter Rossing, Jens Faber, Keif Berum, Natasha Roseva-Nielsen, Birger Thosteinsson. Finland: JormaStrand, Satu Mäkelä, Ilkka Kantola, Timo Strandberg, Arvo Koistinen. France: Gabriel Choukroun, Jean-Pierre Fauvel, Eric Thervet, Philippe Zaoui, Philippe Rieu, Bruno Moulin. Hong Kong: Wing Sun Chow, Risa Ozaki. Hungary: Tibor Fulop, Eleonora Harcsa, Zsuzsanna Kerenyi, NoraKesmarki, Julianna Kiss, Adam Tabak. Israel: Ofri Mosenzon, Yoram Yagil, Julio Wainstein, Oscar Minuchin, Sydney Ben Chetrit, David Jonathan Van Dijk, Anat Jaffe, Nomy Levin-Iaina, Julio Wainstein. Italy: Norberto Perico, Roberto Trevisan, Maurizio Bevilacqua, Ugo Teatini, Antonio Pisani, Angelo Avogaro, Salvatore De Cosmo, Antonello Pani, Stefano Del Prato, Renzo Scanziani, Carlo Antonio Bossi. Republic of Korea: Bong Soo Cha, InJoo Kim, Kun-Ho Yoon. The Netherlands: Ron Gansevoort, Adriaan Kooy, A. G. Lieverse, N. C. Schaper, Mazin Alhakim. Norway: Hilde Selsås, Trine Finnes. Poland: Jerzy Loba, Piotr Napora, Ryszard Sciborski, Miroslawa Polaszewska-Muszynska, Maria Gorska, Jerzy Mosiewicz, Krystyna Jedynasty, Elzbieta Bandurska-Stankiewicz. Portugal: Fernando Nolasco, Francisco Carrilho, Fernando Teixeira, Ana Lourenço, Ana Paula Silva. South Africa: Junaid Bayat, Rohit Dulabh, Graham Ellis, Johan Engelbrecht, Jaco Jurgens, Deepak Lakha, Essack Mitha, Hendrik Nortje, Mahomed Omar, Padaruth RamLachan, Naresh Ranjith, Mohamed Sarvan, Julian Trokis, Louis van Zyl, J. Wing. Spain: Pablo Gómez Fernández, Francisco Martínez Deben, José María Pascual Izuel, Olga González Albarrán, Francesca Calero, Martí Vallès i Prats, José Julián Segura de la Morena. Sweden: Per Oskarsson, Bengt-Olov Tengmark, Erik Beling, Bo Liu, Martin Wehlou, Ewa Jasinska, Johan Jendle, Bernd Ramsauer, Ingemar Torstensson. Taiwan: Kwan-Dun Wu, Wu-Chang Yang, Mai-Szu Wu, Chien-Te Lee. United States: Idalia Acosta, Ahmed Arif, Diogo Belo, Richard Cherlin, Steven Coca, Mohammed El-Shahawy, Leon Fogelfeld, Mark Molitch, Moustafa Moustafa, George Nassar, Philip Raskin, Richard Solomon, Bruce Spinowitz, David Warnock, Steven Zeig, James Tumlin.
Funding/Support: This study was funded by Bayer HealthCare AG.
Role of the Funder/Sponsor: Bayer HealthCare AG, the sponsor, provided financial support for the conduct of the research and preparation of the article. The sponsor could not veto decisions made by the steering committee in the production of this article. Together with the steering committee, the sponsor designed and conducted the study including collection, management, and analysis of data. The members of the steering committee and employees of the sponsor interpreted the data and prepared, reviewed, and approved the manuscript; the sponsor was not involved in the decision to submit the manuscript for publication.
Additional Contributions: We thank the ARTS-DN medical expert, Anna Ferreira, MD (Bayer HealthCare, São Paulo, Brazil), study coordinators Stefania Collamati, MSc (Bayer SpA, Milan, Italy), Catherine Salt, BSc (Bayer PLC, Newbury, England), Anna Lindroth, MSc Pharm (Bayer AB, Solna, Sweden), and Michelle McDade, BSc (Bayer PLC, Newbury, England), statistical analyst Cosima Klein, DiplMath (Bayer HealthCare, Berlin, Germany), and data managers Liubov Shatkina, PhD, and Claudia Prange, MSc (Bayer HealthCare, Berlin, Germany). Medical writing assistance was provided by Charlotte Cookson, DPhil (Oxford PharmaGenesis, Oxford, England), funded by Bayer HealthCare AG.