Heavy menstrual bleeding on direct factor Xa inhibitors: the MEDEA randomized clinical trial.

The MEDEA trial was an independent, investigator-initiated study supported by Boehringer Ingelheim (BI). BI had no role in the design, analysis, or interpretation of the results in this study; BI was given the opportunity to review the manuscript for medical and scientific accuracy as it relates to BI substances, as well as intellectual property considerations. The trial received approval from the Medical Ethical Committee of the Amsterdam University Medical Centers, Amsterdam, The Netherlands. Participants provided written informed consent. E.N.H., H.M.W., B.A.H., H.R.B., S.M., and L.J.S. participated in all aspects of the study and authored the manuscript. All authors interpreted data, reviewed drafts and approved the final version of the manuscript. There are no competing interests to disclose. The authors meet the criteria for authorship as recommended by the International Committee of Medical Journal Editors.

Handling Editor: Dr Bethany Samuelson Bannow Eva N. Hamulyák and Hanke M. G. Wiegers contributed equally to this work. Saskia Middeldorp and Luuk J. J. Scheres share senior authorship.