Main Outcome Measure(s)
Publication stageIn Press Accepted Manuscript
Funding Statement: Financial support was provided by AbbVie, Inc.
Disclosure Statement: W.D.S. has received research support from AbbVie, and has served as a consultant for AbbVie, including the Uterine Disorders National Steering Committee. M.C.S., J.N., I.A., and M.S. are full-time employees of AbbVie, and may own AbbVie stock or stock options. H.L. is a former employee of AbbVie, and may own AbbVie stock or stock options.
Data Sharing Statement: 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 (eg, protocols, clinical study reports, or analysis plans), 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 and execution of a data sharing agreement. Data requests can be submitted at any time after approval in the US and Europe and after acceptance of this manuscript for publication. 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.
Trial Registration: This study was registered at ClinicalTrials.gov (NCT03951077; https://clinicaltrials.gov/ct2/show/NCT03951077). The registration date was May 15, 2019, and the first patient was enrolled on August 12, 2019.
Clinical Trial Registration: NCT03951077
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