Funding for this research was provided by:
AbbVie
Article History
Accepted: 16 January 2021
First Online: 22 March 2021
Declarations
:
: AbbVie funded the studies presented in this manuscript, and was responsible for the study design, research, analysis, data collection, interpretation of data, and writing, reviewing, and approving of the publication.
: Juki Ng, Yi-Lin Chiu, and Cheri E. Klein are employees of AbbVie, Inc., and may own stocks or stock options. Robert A. Feldman is an employee of the Baptist Health Medical Group and was the principal investigator for these studies through Miami Research Associates, LLC, where he received payment for his role in leading the studies.
: 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 the site.
: All participants provided written informed consent for participation in the studies.
: Not applicable.
: AbbVie is committed to responsible data sharing regarding the clinical trials they 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. 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: ExternalRef removed
: Not applicable.
: All authors contributed to the study conception and design and approval of the final content in the manuscript. JN and CK contributed to material preparation, data collection and analysis. Y-LC conducted the study designs, developed statistical methodology, and oversaw the statistical analyses for both studies. RF was the principal investigator for both studies.