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f the report of a BWS after UPA exposure, a possible epigenetic effect could not be excluded and requires further evaluation. STUDY FUNDING/COMPETING INTEREST(S) This work was performed with financial support from the German Federal Institute for Drugs and Medical Devices (BfArM). All authors declare that they have no conflicts of interest. TRIAL REGISTRATION NUMBER Registered with the German Clinical Trial Register (DRKS00015155). © The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Human Repro