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Article History

Accepted: 30 March 2021

First Online: 5 May 2021

Declarations

:

: This study was sponsored by Allergan (prior to its acquisition by AbbVie).

: Ramesh Boinpally, Kayla Chen, and Matthew Butler are employees of AbbVie, and may hold AbbVie stock. John Spaventa was a contingent employee of AbbVie at the time of the study.

: This study was conducted in accordance with the principles of the Declaration of Helsinki and the International Council for Harmonisation (ICH) E6 guideline for Good Clinical Practice. The study protocol was approved by Bio-Kinetic Clinical Applications IRB (Springfield, MO, USA).

: All participants provided written informed consent prior to initiation of any study-specific procedures.

: Not applicable.

: 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:.

: Not applicable.

: Study design: JS; RB. Collection and assembly of data: JS; RB; KC. Data analysis: RB; KC. Data interpretation: all authors. Manuscript review and revisions: All authors. Final approval of manuscript: All authors