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About the article
Published Online: 2019-08-02
Published in Print: 2019-09-25
Author contributions: PS, AB, MD and WH conceived the study. MD enrolled the participants. AB and MD collected the data. AB, MD, HH and TFD analyzed the data. AB, MD, HH and PS interpreted the data. AB, MD and PS wrote the article. All authors critically reviewed and amended multiple drafts of the manuscript’s concept and outline, as well as the full manuscript, and all authors approved the final draft of the manuscript. All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Conflicts of interest: PS received consultation fees from Ferring Pharmaceuticals with regard to prostaglandin vaginal inserts. None of the other authors of this study have any relevant conflicts of interest (financial, personal, political, intellectual or religious) to disclose. The full disclosure of interests is available to view online as supporting information. The authors have had full control of the primary data and they allow the journal to review the data if requested.
Research funding: This investigator-initiated trial was supported by a grant from Ferring Pharmaceuticals. The contract details are available online as supporting information.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
Ethical approval: All procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. During this study, no animals were used by any of the authors. This study is a collaboration between Asklepios Hamburg and Charité – University Medical Center Berlin. It is part of the medical thesis of the first author, who is registered and supervised at Charité – University Medical Center Berlin. However, patients were recruited at Asklepios Clinic Barmbek, Hamburg; therefore, the ethical committee was chosen there.
Supplementary material: Ethical committee approval and grant contract.