Klünder, Ben
Mittapalli, Rajendar K.
Mohamed, Mohamed-Eslam F.
Friedel, Anna
Noertersheuser, Peter
Othman, Ahmed A. http://orcid.org/0000-0002-4937-2775
Funding for this research was provided by:
AbbVie
Article History
First Online: 3 April 2019
Compliance with Ethical Standards
:
: The studies were designed according to good clinical practice guidelines, the Declaration of Helsinki, and applicable regulations, and were approved by Institutional Review Boards. All participants provided written informed consent.
: This study was sponsored by AbbVie Inc., who contributed to the study design; research; data interpretation; and writing, review and approval of the abstract for publication.
: Ben Klünder, Rajendar K. Mittapalli, Mohamed-Eslam F. Mohamed, Anna Friedel, Peter Noertersheuser and Ahmed A. Othman are employees or former employees of AbbVie Inc., and may hold AbbVie stocks or options.
: 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.The 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: ExternalRef removed.