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☆Funding: The study was funded by Exeltis.
☆☆Conflict of interest: D. Drouin is employee of Exeltis France. E.Colli is employee of Exeltis Spain. D. Heger-Mahn and I. Duijkers are directors of Dinox, a contract research organization that received funding from Exeltis to perform the study. S. Skouby is consultant for manufacturers of hormonal products including contraceptives and postmenopausal therapy.
☆☆☆Clinical trial registration number: EudraCT 2013–001,513-33.