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Article History

Received: 9 March 2020

Accepted: 13 October 2020

First Online: 27 October 2020

Ethics approval and consent to participate

: The studies were conducted in accordance with the Declaration of Helsinki, local independent ethics committee/institutional review board requirements, and good clinical practice guidelines. Shulman Associates IRB conducted the majority of the IRB approvals (M12–665 IRB approval number 201202559 approval date April 11, 2012; M12–671 IRB approval number 201208471, approval date on November 16, 2012). Informed consent was obtained from all individual participants included in the study. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and Clinical Study Reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

: Not applicable.

: A. Soliman and M. Snabes are employees of and own stock/stock options in AbbVie. R. Pokrzywinski and KS. Coyne are employees of Evidera, who were paid consultants to AbbVie in connection with this study. Eric Surrey is Medical Director at Colorado Center for Reproductive Medicine, has served in a consulting role for AbbVie and DOT Laboratories, received research grants from AbbVie, and served on the speaker bureau for AbbVie and Ferring Laboratories. Evidera received funding from AbbVie to conduct the study and for medical writing.