Article History
Received: 12 May 2020
Accepted: 17 September 2020
First Online: 2 October 2020
Ethics approval and consent to participate
: The overall approval for the trial 1 with the leading ethical committee was given the 01.07.2011 by the Ethikkommission des Landes Sachsen-Anhalt, Geschäftsstelle, number 10/0607 EK. The overall approval for the trial 2 with the leading ethical committee was given the 13.07.2012 by the Landesamt für Gesundheit und Soziales Berlin, Geschäftstelle der Ethik Kommission des Landes Berlin, number 11/0606 EK.The dates on which the records were first entered in the EudraCT database were between 2010 and 11-05 and 2011-04-14. The EudraCT is since the 2011-03-22 open and public available. As documented in the submitted protocol of study 1, the date the first subject entered was 2011-07-11. EudraCT registration numbers: 2010–021787-15 & 2011–002396-42. Registration was at Clincaltrials.gov: NCT02269241 for the USA trial.All participants consented written to participate in the clinical trials.
: Consent for publication of identifying images or other personal or clinical details of participants that compromises anonymity:Not Applicable.
: Santiago Palacios is a consultant to Pfizer, Amgen, MSD, Gynea, Procare Health, Bayer, Sérélys Shinogi, Exeltis, Abbott, and Gedeon Richter. Enrico Colli and Pedro Antonio Regidor are employees of Exeltis. Santiago Palacios is an editorial member of BMC Women’s Health.