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Article History

First Online: 4 May 2019

Ethics

: <b>Compliance with Ethical Standards</b>

: This work was supported by Boehringer Ingelheim and AbbVie. Boehringer Ingelheim contributed to the study designs and data collection and AbbVie contributed to the analysis and interpretation of the data and the writing, review, and approval of the manuscript.

: Ahmed A. Suleiman, Mukul Minocha, Amit Khatri, Yinuo Pang, and Ahmed A. Othman are employees of AbbVie and may hold AbbVie stock or stock options.

: All studies were conducted in accordance with Good Clinical Practice guidelines and the ethical principles that have their origin in the Declaration of Helsinki. The protocols and informed consent forms were approved by the ethics committee or institutional review board at each site.

: All participants provided written informed consent for participation in the studies.

: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual, and trial-level data (analysis datasets), 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. This clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. For more information on the process, or to submit a request, visit the following link: .