Received: 25 August 2020
Accepted: 9 November 2020
First Online: 19 November 2020
Ethics approval and consent to participate
: Patient data for this study were considered de-identified in accordance with the HIPAA Privacy Rule described in Title 45 of the US Code of Federal Regulations (CFR) Part 164.506(d)(2)(ii)(B) and are exempt from Institutional Review Board (IRB) oversight, as provided in 45 CFR 46.101(b)(4) [CitationRef removed, CitationRef removed]. The protocol for this study was nonetheless submitted to Western IRB (Puyallup, WA), which confirmed its exempt status.
: BW, JBM, MAM, and KD are employees of LifeNet Health®, a non-profit organization, which funded the study. VK was an independent biostatistical consultant for LifeNet Health® in the preparation of this manuscript. However, potential bias was minimized through a study design where real-world data were obtained from a third-party database offered by Premier Healthcare Solutions, Inc. (Charlotte, NC), which allows for evidence- and population-based analyses of drugs, devices, other treatments, disease states, epidemiology, resource utilization, healthcare economics, and clinical outcomes.