Kim Annink

187 ALBINO trial: study protocol TRIAL STATUS Protocol version 5: 19. December 2017. Recruitment has started in April 2018 and is expected to be finalized in April 2020. The last patient out (after follow-up) will then be expected in April 2022. ACKNOWLEDGMENTS The ALBINO consortium is indebted to Silke Mader and Nicole Thiele from the European Foundation for the Care of Newborn Infants (EFCNI) who granted a letter of support for the ALBINO trial after careful evaluation of the various arguments. We would also like to thank the members of the Data Monitoring Committee: Michael Weindling (University of Liverpool), Sandra Juul (University of Washington), Steven Miller (Hospital for Sick Children Toronto), Edwin Spaans (Erasmus University Rotterdam) and Josef Högel (University of Ulm), and the members of the ALBINO External Advisory Board: Seetha Shankaran (Wayne State University Detroit) and Neil Marlow (University College London). FUNDING This study is funded under the Horizon 2020 Framework Program of the European Union, call H2020-PHC-2015-two-stage, grant 667224. The European Union/European Commission had no influence on the design of the study, on collection, analysis and interpretation of data and on writing this manuscript. Publication of this manuscript was supported by Deutsche Forschungsgemeinschaft and the Open Access Publishing Fund of the University of Tuebingen. They had no influence on the design of the study, on collection, analysis and interpretation of data and on writing this manuscript. DISCLOSURES Y. Jacobs and R. van der Vlught-Meijer are employees of ACE Pharmaceuticals, the company that holds the Dutch marketing authorization registration for Acepurin® (allopurinol 1g/100ml) for intravenous application for treatment of gout. C. van Veldhuizen and B. Laméris are the former owners of ACE Pharmaceuticals. All four contributed to the development of the study protocol. All other contributors declare that they do not have competing interest. 8