99 FRAIL-AF RANDOMISED CONTROLLED TRIAL: RATIONALE AND DESIGN FUNDING The FRAIL-AF study is mainly supported by The Netherlands Organisation for Health Research and Development (ZonMw number 848015004). The University Medical Center Utrecht supports this study with additional institutional funding. Furthermore, the FRAIL-AF study receives unrestricted educational grants of all four NOAC selling pharmaceutical companies (Boehringer-Ingelheim, Bayer Healthcare, BMS Pfizer, Daiichi Sankyo) for symposia and for the development of training material. There are no restrictions to the execution of the study or the publication process by any of the subsiding parties as confirmed by the Dutch Advertising Code Committee. GJG is supported by a VENI grant from the Netherlands Organisation for Health Research and Development (ZonMw number 016.166.030). POTENTIAL CONFLICTS OF INTEREST MEWH reports grants from The Netherlands Organisation for Health Research and Development (ZonMw) and personal fees from Boehringer Ingelheim, Bayer Healthcare, Bristol-Myers Squibb/Pfizer Alliance and Daiichi Sankyo. MVH reports grants from The Netherlands Organisation for Health Research and Development (ZonMw) and Dutch Healthcare Fund and grants and personal fees from Boehringer Ingelheim, Bayer Healthcare, Bristol-Myers Squibb/Pfizer Alliance, Daiichi Sankyo and Aspen. FR and GJG report unrestricted institutional grants for performing research in the field of atrial fibrillation from Boehringer Ingelheim, Bayer Healthcare, BristolMyers Squibb/Pfizer Alliance and Daiichi Sankyo. The other authors declare that they have no conflicts of interest. CONTRIBUTORS GJG, FR and AH conceived and initiated the study. LJ, SvD, MN, NW, HK, MEWH, MVH and WB provided input on the study design, with RvdB and KR providing statistical and trial expertise. LJ and GJG wrote the first version of the manuscript. All authors critically reviewed and revised the manuscript. ACKNOWLEDGEMENT We express our gratitude to all additional members of the FRAIL-AF study group, including dr. M.A. Brouwer (cardiologist), dr. M. Coppens (internist), dr. M.W.F. van Leen (specialist in geriatric medicine), and Prof. dr. S. Middeldorp (internist), for their valuable input in drafting the study protocol. 6
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