{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T23:45:19Z","timestamp":1792107919371,"version":"4.4.0"},"reference-count":33,"publisher":"Springer Science and Business Media LLC","issue":"12","license":[{"start":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T00:00:00Z","timestamp":1783296000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T00:00:00Z","timestamp":1783296000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100009109","name":"Pharmaceuticals Bayer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100009109","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Pediatr Nephrol"],"published-print":{"date-parts":[[2026,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>In recent years, real-world data have been increasingly used to enrich data from interventional studies on treatment effectiveness. To explore the viability of hybrid study designs in pediatric chronic kidney disease (CKD), we assessed the feasibility of identifying a real-world cohort of children with CKD and severely increased proteinuria who satisfied adapted eligibility criteria from the FIONA trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We used data from the Optum\u00ae de-identified Electronic Health Record dataset (Optum\u00ae EHR) to identify and characterize children with CKD and severely increased proteinuria in records from January 2013 to December 2022. Patients were identified based on two sets of estimated glomerular filtration rate (eGFR)\/serum creatinine and urine protein-to-creatinine ratio (UPCR) measures within a 90- to 365-day period (final date\u2009=\u2009index). Patients were required to satisfy adapted eligibility criteria from the FIONA trial and have a baseline prescription for angiotensin-converting enzyme inhibitors (ACEi)\/angiotensin receptor blockers (ARBs). Patients were stratified by eGFR and UPCR. Patient characteristics, comorbidities, and medications were descriptively reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      We identified a total of 381 children with CKD and severely increased proteinuria (median age: 14\u00a0years; 52.6% male), among whom 80.8% had eGFR\u2009\u2265\u200960\u00a0mL\/min\/1.73 m\n                      <jats:sup>2<\/jats:sup>\n                      and 69.0% had UPCR\u2009&gt;\u20091\u00a0g\/g. The patient distribution by CKD stage was: G1, 50.9%; G2, 29.9%; G3\u20134, 19.2%. Among 397 patients who were excluded given no baseline ACEi\/ARB use,\u2009&gt;\u200920% initiated ACEi\/ARBs within 6\u00a0months following index.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Our study demonstrated the feasibility of identifying a real-world pediatric cohort with CKD and severely increased proteinuria using adapted criteria from the FIONA trial. Findings from this study highlight factors that should be considered in the design of future hybrid studies evaluating treatment effectiveness using data from both trials and the real world.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Graphical abstract<\/jats:title>\n                    <jats:p>A higher resolution version of the Graphical abstract is available as Supplementary information.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00467-026-07435-y","type":"journal-article","created":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T14:24:59Z","timestamp":1783347899000},"page":"4487-4500","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Characterizing children with chronic kidney disease and severe proteinuria in the United States: a retrospective analysis using electronic health records"],"prefix":"10.1007","volume":"41","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1812-6587","authenticated-orcid":false,"given":"Bradley A.","family":"Warady","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7503-1213","authenticated-orcid":false,"given":"Simone","family":"Heeg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alfredo E.","family":"Farjat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7685-1333","authenticated-orcid":false,"given":"Rachel","family":"Knapp","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0554-8361","authenticated-orcid":false,"given":"Siir Su","family":"Saydam","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Vowinkel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alain","family":"Gay","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Potts","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9367-5773","authenticated-orcid":false,"given":"Andrea","family":"Scalise","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gordana","family":"Atanackovic","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6518-7254","authenticated-orcid":false,"given":"Sascha","family":"van Boemmel-Wegmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,7,6]]},"reference":[{"key":"7435_CR1","doi-asserted-by":"publisher","first-page":"1389","DOI":"10.1007\/s00467-022-05816-7","volume":"38","author":"J Harambat","year":"2023","unstructured":"Harambat J, Madden I (2023) What is the true burden of chronic kidney disease in children worldwide? Pediatr Nephrol 38:1389\u20131393. https:\/\/doi.org\/10.1007\/s00467-022-05816-7","journal-title":"Pediatr Nephrol"},{"key":"7435_CR2","unstructured":"United States Renal Data System (2024) USRDS Annual Data Report: edpidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. https:\/\/usrds-adr.niddk.nih.gov\/2024\/. Accessed 13 Oct 2025"},{"key":"7435_CR3","doi-asserted-by":"publisher","first-page":"1999","DOI":"10.1007\/s00467-006-0410-1","volume":"22","author":"BA Warady","year":"2007","unstructured":"Warady BA, Chadha V (2007) Chronic kidney disease in children: the global perspective. Pediatr Nephrol 22:1999\u20132009. https:\/\/doi.org\/10.1007\/s00467-006-0410-1","journal-title":"Pediatr Nephrol"},{"key":"7435_CR4","doi-asserted-by":"publisher","first-page":"S117","DOI":"10.1016\/j.kint.2023.10.018","volume":"105","author":"Kidney Disease: Improving Global Outcomes CKD Work Group","year":"2024","unstructured":"Kidney Disease: Improving Global Outcomes CKD Work Group (2024) KDIGO 2024 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int 105:S117\u2013S314. https:\/\/doi.org\/10.1016\/j.kint.2023.10.018","journal-title":"Kidney Int"},{"key":"7435_CR5","doi-asserted-by":"publisher","first-page":"366","DOI":"10.1111\/j.1399-3046.2007.00704.x","volume":"11","author":"JM Smith","year":"2007","unstructured":"Smith JM, Stablein DM, Munoz R, Hebert D, McDonald RA (2007) Contributions of the Transplant Registry: the 2006 annual report of the North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS). Pediatr Transplant 11:366\u2013373. https:\/\/doi.org\/10.1111\/j.1399-3046.2007.00704.x","journal-title":"Pediatr Transplant"},{"key":"7435_CR6","doi-asserted-by":"publisher","first-page":"1987","DOI":"10.1007\/s00467-014-2812-9","volume":"29","author":"NM Rodig","year":"2014","unstructured":"Rodig NM, McDermott KC, Schneider MF et al (2014) Growth in children with chronic kidney disease: a report from the Chronic Kidney Disease in Children Study. Pediatr Nephrol 29:1987\u20131995. https:\/\/doi.org\/10.1007\/s00467-014-2812-9","journal-title":"Pediatr Nephrol"},{"key":"7435_CR7","doi-asserted-by":"publisher","first-page":"2132","DOI":"10.2215\/CJN.07100810","volume":"6","author":"SL Furth","year":"2011","unstructured":"Furth SL, Abraham AG, Jerry-Fluker J et al (2011) Metabolic abnormalities, cardiovascular disease risk factors, and GFR decline in children with chronic kidney disease. Clin J Am Soc Nephrol 6:2132\u20132140. https:\/\/doi.org\/10.2215\/CJN.07100810","journal-title":"Clin J Am Soc Nephrol"},{"key":"7435_CR8","doi-asserted-by":"publisher","DOI":"10.1155\/2013\/970946","volume":"2013","author":"P Salas","year":"2013","unstructured":"Salas P, Pinto V, Rodriguez J, Zambrano MJ, Mericq V (2013) Growth retardation in children with kidney disease. Int J Endocrinol 2013:970946. https:\/\/doi.org\/10.1155\/2013\/970946","journal-title":"Int J Endocrinol"},{"key":"7435_CR9","doi-asserted-by":"publisher","first-page":"583","DOI":"10.1093\/ckj\/sfw047","volume":"9","author":"F Becherucci","year":"2016","unstructured":"Becherucci F, Roperto RM, Materassi M, Romagnani P (2016) Chronic kidney disease in children. Clin Kidney J 9:583\u2013591. https:\/\/doi.org\/10.1093\/ckj\/sfw047","journal-title":"Clin Kidney J"},{"key":"7435_CR10","doi-asserted-by":"publisher","first-page":"363","DOI":"10.1007\/s00467-007-0643-7","volume":"23","author":"C Hadtstein","year":"2008","unstructured":"Hadtstein C, Schaefer F (2008) Hypertension in children with chronic kidney disease: pathophysiology and management. Pediatr Nephrol 23:363\u2013371. https:\/\/doi.org\/10.1007\/s00467-007-0643-7","journal-title":"Pediatr Nephrol"},{"key":"7435_CR11","doi-asserted-by":"publisher","first-page":"785","DOI":"10.1093\/ndt\/gfp570","volume":"25","author":"C Rinat","year":"2010","unstructured":"Rinat C, Becker-Cohen R, Nir A et al (2010) A comprehensive study of cardiovascular risk factors, cardiac function and vascular disease in children with chronic renal failure. Nephrol Dial Transplant 25:785\u2013793. https:\/\/doi.org\/10.1093\/ndt\/gfp570","journal-title":"Nephrol Dial Transplant"},{"key":"7435_CR12","doi-asserted-by":"publisher","DOI":"10.1007\/s00467-025-06838-7","author":"C Pucci","year":"2025","unstructured":"Pucci C, Marazza DS, Preka E, Mastrangelo A, Montini G, Boyer O (2025) SGLT2 inhibitors for kidney protection in children: expanding horizons beyond endocrinology. Pediatr Nephrol. https:\/\/doi.org\/10.1007\/s00467-025-06838-7","journal-title":"Pediatr Nephrol"},{"key":"7435_CR13","doi-asserted-by":"publisher","first-page":"1639","DOI":"10.1056\/NEJMoa0902066","volume":"361","author":"ESCAPE Trial Group","year":"2009","unstructured":"ESCAPE Trial Group (2009) Strict blood-pressure control and progression of renal failure in children. N Engl J Med 361:1639\u20131650. https:\/\/doi.org\/10.1056\/NEJMoa0902066","journal-title":"N Engl J Med"},{"key":"7435_CR14","doi-asserted-by":"publisher","first-page":"26","DOI":"10.1016\/S2352-4642(22)00302-9","volume":"7","author":"MD Sinha","year":"2023","unstructured":"Sinha MD, Gu H, Douiri A et al (2023) Intensive compared with less intensive blood pressure control to prevent adverse cardiac remodelling in children with chronic kidney disease (HOT-KID): a parallel-group, open-label, multicentre, randomised, controlled trial. Lancet Child Adolesc Health 7:26\u201336. https:\/\/doi.org\/10.1016\/S2352-4642(22)00302-9","journal-title":"Lancet Child Adolesc Health"},{"key":"7435_CR15","unstructured":"Kidney Disease: Improving Global Outcomes CKD Work Group (2024) Top 12 special considerations in children and young adults from the KDIGO 2024 clinical practice guideline for the evaluation and management of chronic kidney disease. https:\/\/kdigo.org\/wp-content\/uploads\/2025\/03\/KDIGO-2024-CKD-Guideline-Key-Takeaways-for-Pediatricians.pdf. Accessed 20 March 2026"},{"key":"7435_CR16","doi-asserted-by":"publisher","first-page":"1751","DOI":"10.1007\/s00467-020-04788-w","volume":"36","author":"EY Chan","year":"2021","unstructured":"Chan EY, Ma AL, Tullus K (2021) When should we start and stop ACEi\/ARB in paediatric chronic kidney disease? Pediatr Nephrol 36:1751\u20131764. https:\/\/doi.org\/10.1007\/s00467-020-04788-w","journal-title":"Pediatr Nephrol"},{"key":"7435_CR17","doi-asserted-by":"publisher","first-page":"2219","DOI":"10.1056\/NEJMoa2025845","volume":"383","author":"GL Bakris","year":"2020","unstructured":"Bakris GL, Agarwal R, Anker SD et al (2020) Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes. N Engl J Med 383:2219\u20132229. https:\/\/doi.org\/10.1056\/NEJMoa2025845","journal-title":"N Engl J Med"},{"key":"7435_CR18","doi-asserted-by":"publisher","first-page":"2252","DOI":"10.1056\/NEJMoa2110956","volume":"385","author":"B Pitt","year":"2021","unstructured":"Pitt B, Filippatos G, Agarwal R et al (2021) Cardiovascular events with finerenone in kidney disease and type 2 diabetes. N Engl J Med 385:2252\u20132263. https:\/\/doi.org\/10.1056\/NEJMoa2110956","journal-title":"N Engl J Med"},{"key":"7435_CR19","doi-asserted-by":"publisher","first-page":"203","DOI":"10.1186\/s13063-024-08021-z","volume":"25","author":"F Schaefer","year":"2024","unstructured":"Schaefer F, Montini G, Kang HG et al (2024) Investigating the use of finerenone in children with chronic kidney disease and proteinuria: design of the FIONA and open-label extension studies. Trials 25:203. https:\/\/doi.org\/10.1186\/s13063-024-08021-z","journal-title":"Trials"},{"key":"7435_CR20","unstructured":"Bayer (2026) A study to learn more about how well the study treatment finerenone works, how safe it is, how it moves into, through, and out of the body, and the effects it has on the body when taken with an ACE inhibitor or angiotensin receptor blocker in children with chronic kidney disease and proteinuria (FIONA). ClinicalTrials.gov. https:\/\/clinicaltrials.gov\/study\/NCT05196035. Accessed 12 Feb 2026"},{"key":"7435_CR21","doi-asserted-by":"publisher","first-page":"357","DOI":"10.1111\/bcp.12305","volume":"79","author":"PD Joseph","year":"2015","unstructured":"Joseph PD, Craig JC, Caldwell PH (2015) Clinical trials in children. Br J Clin Pharmacol 79:357\u2013369. https:\/\/doi.org\/10.1111\/bcp.12305","journal-title":"Br J Clin Pharmacol"},{"key":"7435_CR22","doi-asserted-by":"publisher","first-page":"174","DOI":"10.1177\/1932296819832653","volume":"14","author":"DC Klonoff","year":"2020","unstructured":"Klonoff DC (2020) The expanding role of real-world evidence trials in health care decision making. J Diabetes Sci Technol 14:174\u2013179. https:\/\/doi.org\/10.1177\/1932296819832653","journal-title":"J Diabetes Sci Technol"},{"issue":"Suppl 2","key":"7435_CR23","doi-asserted-by":"publisher","first-page":"S38","DOI":"10.1002\/jcph.2134","volume":"62","author":"J Liu","year":"2022","unstructured":"Liu J, Barrett JS, Leonardi ET et al (2022) Natural history and real-world data in rare diseases: applications, limitations, and future perspectives. J Clin Pharmacol 62(Suppl 2):S38\u2013S55. https:\/\/doi.org\/10.1002\/jcph.2134","journal-title":"J Clin Pharmacol"},{"key":"7435_CR24","unstructured":"Optum (2025) Optum claims data. https:\/\/business.optum.com\/en\/data-analytics\/life-sciences\/real-world-data\/claims-data.html. Accessed 20 March 2026"},{"key":"7435_CR25","doi-asserted-by":"publisher","first-page":"948","DOI":"10.1016\/j.kint.2020.10.047","volume":"99","author":"CB Pierce","year":"2021","unstructured":"Pierce CB, Mu\u00f1oz A, Ng DK, Warady BA, Furth SL, Schwartz GJ (2021) Age- and sex-dependent clinical equations to estimate glomerular filtration rates in children and young adults with chronic kidney disease. Kidney Int 99:948\u2013956. https:\/\/doi.org\/10.1016\/j.kint.2020.10.047","journal-title":"Kidney Int"},{"key":"7435_CR26","doi-asserted-by":"publisher","first-page":"173","DOI":"10.2215\/CJN.0000000000000051","volume":"18","author":"CA Gluck","year":"2023","unstructured":"Gluck CA, Forrest CB, Davies AG et al (2023) Evaluating kidney function decline in children with chronic kidney disease using a multi-institutional electronic health record database. Clin J Am Soc Nephrol 18:173\u2013182. https:\/\/doi.org\/10.2215\/CJN.0000000000000051","journal-title":"Clin J Am Soc Nephrol"},{"key":"7435_CR27","doi-asserted-by":"publisher","first-page":"1002","DOI":"10.1053\/j.ajkd.2012.07.018","volume":"60","author":"CJ Wong","year":"2012","unstructured":"Wong CJ, Moxey-Mims M, Jerry-Fluker J, Warady BA, Furth SL (2012) CKiD (CKD in children) prospective cohort study: a review of current findings. Am J Kidney Dis 60:1002\u20131011. https:\/\/doi.org\/10.1053\/j.ajkd.2012.07.018","journal-title":"Am J Kidney Dis"},{"key":"7435_CR28","doi-asserted-by":"publisher","first-page":"812","DOI":"10.2215\/CJN.01780408","volume":"4","author":"CS Wong","year":"2009","unstructured":"Wong CS, Pierce CB, Cole SR et al (2009) Association of proteinuria with race, cause of chronic kidney disease, and glomerular filtration rate in the chronic kidney disease in children study. Clin J Am Soc Nephrol 4:812\u2013819. https:\/\/doi.org\/10.2215\/CJN.01780408","journal-title":"Clin J Am Soc Nephrol"},{"key":"7435_CR29","doi-asserted-by":"publisher","first-page":"1096","DOI":"10.34067\/KID.0000000753","volume":"6","author":"JM Beus","year":"2025","unstructured":"Beus JM, Liu KD, Westbrook A et al (2025) Incidence of leading causes of pediatric CKD using electronic health record-driven computable phenotype. Kidney360 6:1096\u20131105. https:\/\/doi.org\/10.34067\/KID.0000000753","journal-title":"Kidney360"},{"key":"7435_CR30","doi-asserted-by":"publisher","first-page":"1606","DOI":"10.7326\/M23-1023","volume":"176","author":"R Agarwal","year":"2023","unstructured":"Agarwal R, Tu W, Farjat AE et al (2023) Impact of finerenone-induced albuminuria reduction on chronic kidney disease outcomes in type 2 diabetes: a mediation analysis. Ann Intern Med 176:1606\u20131616. https:\/\/doi.org\/10.7326\/M23-1023","journal-title":"Ann Intern Med"},{"key":"7435_CR31","doi-asserted-by":"publisher","first-page":"912","DOI":"10.2215\/CJN.11971116","volume":"12","author":"DY Fuhrman","year":"2017","unstructured":"Fuhrman DY, Schneider MF, Dell KM et al (2017) Albuminuria, proteinuria, and renal disease progression in children with CKD. Clin J Am Soc Nephrol 12:912\u2013920. https:\/\/doi.org\/10.2215\/CJN.11971116","journal-title":"Clin J Am Soc Nephrol"},{"key":"7435_CR32","first-page":"248","volume":"95","author":"AK Leung","year":"2017","unstructured":"Leung AK, Wong AH, Barg SS (2017) Proteinuria in children: evaluation and differential diagnosis. Am Fam Physician 95:248\u2013254","journal-title":"Am Fam Physician"},{"key":"7435_CR33","doi-asserted-by":"publisher","first-page":"466","DOI":"10.1053\/j.ajkd.2022.09.017","volume":"81","author":"BA Warady","year":"2023","unstructured":"Warady BA, Feldman DL, Bell LE et al (2023) Improving clinical care for children with CKD: a report from a national kidney foundation scientific workshop. Am J Kidney Dis 81:466\u2013474. https:\/\/doi.org\/10.1053\/j.ajkd.2022.09.017","journal-title":"Am J Kidney Dis"}],"container-title":["Pediatric Nephrology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00467-026-07435-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00467-026-07435-y","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00467-026-07435-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T22:54:32Z","timestamp":1792104872000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00467-026-07435-y"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,6]]},"references-count":33,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2026,12]]}},"alternative-id":["7435"],"URL":"https:\/\/doi.org\/10.1007\/s00467-026-07435-y","relation":{},"ISSN":["0931-041X","1432-198X"],"issn-type":[{"value":"0931-041X","type":"print"},{"value":"1432-198X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,6]]},"assertion":[{"value":"24 March 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"15 May 2026","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"17 June 2026","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"6 July 2026","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Use of Optum\u00ae EHR was reviewed by the New England Institutional Review Board and was determined to be exempt because the project did not involve human subject research.","order":1,"name":"Ethics","label":"Ethics approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"BAW is a member of the Steering Committee of the FIONA trial and has received honoraria from Bayer.\u00a0SH, AEF, RK, JP, AS, and GA are employees of Bayer.\u00a0SSS, AV,\u00a0AG, and SvBW were employees of Bayer at the time of study conduct.","order":2,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Declarations"}}]}}