Conflict of interest

All authors are employees at AbbVie and may hold AbbVie stock.

Funding

AbbVie provided financial support for the studies and participated in the study design, study conduct, and analysis and interpretation of data and the writing, review, and approval of the manuscript.

Ethics approval

The 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 were approved by the institutional review board or ethics committee for each site.

Consent to participate

Each subject provided written informed consent before any study-related procedures were performed.

Consent for publication

All authors provided consent for publication.

Data availability

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. 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: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html.

Code availability

Not available.

Author contributions

AVPB, MJC, and SS wrote the manuscript. AVPB, MJC, SS, NM, IW, SM, JB, TH, and ID analyzed data, performed research, and contributed new analytical tools. AVPB, SS, NM, JB, TH, and ID designed research. LL supervised analysis and research for both studies.