Received: 26 May 2022
Accepted: 16 January 2023
First Online: 24 January 2023
: This was a retrospective analysis of deidentified data from a US based proprietary database. The data is a limited data set with data use agreements in place for use. It only contains de-identified health information that, as described by the HIPPA Privacy Rule, is not PHI. A limited dataset excludes specified direct identifiers of the individual or of relatives, employers, or household members of the individual. The Optum EHR database meets these criteria. Access to and use of the data available only through a license agreement. The license (obtained by AbbVie) describes the data, limitations on use, limitations on users and specifically prohibits re-identification. It also includes reference to the HIPPA Privacy Rule: 45 CFR 164.501, 164.508, 164.512(i). For these reasons, our data is not covered by the Privacy Rule and IRB approval was’t required. As this was an observational retrospective study, there was no experimental protocol, however, all analyses were approved by the sponsor (AbbVie). All procedures were performed in accordance with relevant guidelines.
: Individual patient data in the database from which this dataset was derived are deidentified and consent for publication is not required.
: WS, AKRM, RK, & AL are all employees of AbbVie and own stock. At the time the study was conducted, JET was an employee of AbbVie. RP, DM, AG, EP are employed by SmartAnalyst and received funding from AbbVie to conduct the study.