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 2010-11-05 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 to participate in the clinical trial.
Consent for publication
All authors have consented for publication.
There is no identifying information in this manuscript.
If identifying images or other personal or clinical details of participants are presented that compromise anonymity, a statement of consent to publish from the patient should be included.
Not Applicable.
Availability of data and material
Clinical trial register: Registration was at clincaltrials.gov: NCT02269241 for the USA trial and EudraCT registration numbers: 2010-021787-15 & 2011-002396-42 for the European trails.
Funding
Not applicable
Competing interests
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.
Authors' contributions
All authors have read and approved the manuscript.
SP and EC were responsible for the practical realization of the study. PAR was responsible for the writing and coordination of the manuscript.
Acknowledgements
The authors wish to thank SCOPE international ING for the management and statistical analysis of the studies and the investigators of the studies in Europe: Austria: C. Egarter, Czech Republic: V. Dvorák ,O. Hlavácková, V. Horejsí, L. Horcicka, I. Huvar, B. Hynková, J. Jenícek, I. Kalousek, D. Makalová, M. Rozbroj, A. Skrivánek, A. Stará, M. Svec, M. Sykorová, Z. Tesar, R. Vetesníkova-Koubová; Germany: Ahrendt, HJ, K. Bühling, C. Büchau, C. Burgkhardt, P. Cassel, T. Gent, W. Göttker-Schnetmann, K. Greven, J. Herold, L. Hoppe, T. Kränzlin, P. Kressin, K. Maar, K. Peters, D. Rautenberg, G. Schalk V. Schlothauer, S. Schönian; Hungary: , L. Harsányi, L. Hernádi, M. Horváth, Z. Langmár, L. Molnár, Z. Novák, B. Pálmai, P. Podör, P. Siklós, G. Spánik, I. Székely, I. Szentpéteri, G. Szonyi, L. Zámbó; Poland: O. Adamczyk, A. Chelmicki, B. Golánski, A. Jakimiuk, P. Jaszcynski, M. Jedrzejczyk, S. Jedrzejczyk, A. Kowalska, J. Kotarski, Z. Madejski, A. Nawra-Baran, A. Pakalski, I. Polác, M. Radecka, T. Rechberger, V. Skrzypulec-Plinta, K. Sodowski, J. Tomaszewski, E. Wisniewska-Sawicka; Romania: C. Anatasiu, M. Dumitrascu, DG Gogonea, V. Gheorman, V. Manescu, D. Munteanu, OC. Rotaru, D. Tutunaru; Spain: E. Balager Martínez, C. Bergós Sorolla, SP. Gonzalez Rodriguez, J. Grau Galtés, S Palacios Gil-Antunano, A. Pessarrodona Isern, R. Sánchez Borrego; Slovakia: K. Biringer, V. Cupanik, J. Danko, J. Fathiová, A. Gát’ová, Z. Petrovicová, R. Sládiceková, J. Suteková .
In USA: Study investigators were R. Ackerman, M.D., FACOG; E. Andruczyk, M.D., FACOG, MBA; K.T. Barnhard, M.D., MSCR; R. Beyer, M.D., M.A., FACOG, CPI; P.P. Bhiwandiwala (Bhiwandi), M.D., FACOG; S. Blank, M.D.; A.E. Burke, M.D., M.P.H.; S.E. Chavoustie, M.D., FACOG, CCRP; T. Copper, M.D., A.J. Donovan, M.D.; S.E. Eder, M.D., FACOG, FACS; C.D.
Eubank, Jr., M.D., FACOG; R.A. Felman, M.D.; F. Fisk, M.D., FACOG; H. Green,M.D.; R. Hedrick,M.D.; J.N. Hernandez,M.D., FACOG; C. Huffman, M.D.; M.A. Jacobs, M.D.; TD Kimble, M.D.; S. Kim, M.D., R. Kroll, M.D., FACOG; S.N. Lederman, M.D.; G.C. Lefebvre, M.D.; A. London, M.D.; J.A. Mickelson, M.D., CPI; A.S. Murthy, M.D., M.P.H., FACOG; D.M. Radin, M.D.; R. Reagan, M.D.; S.W. Robison, M.D.; W.D. Summers, M.D.; S. Sussman, M.D.; M.A. Thomas, M.D.; P. Thompson, M.D.; M. Twede, M.D., FACOG; A.S. Waldbaum, M.D.; K.K. Waldrep, M.D.; D. Walland, M.D.; L.S. Wan, M.D.; C. Westhoff, M.D.; P. Winkle, M.D., FACP, FACOG, CPI; and D.B. Young, M.D.