The study was reviewed and approved by the Ethical Committee of the University Hospital Jena, Germany (approval # 4629–12/15). Follow votes were obtained for study sites in Berlin, Munich, Halle and Walsrode. All women signed an informed consent form in their native language permitting the use of their data and serum sample for scientific purposes. The study was registered with the US national library of medicine (ClinicalTrials.gov Identifier: NCT03158298).

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