Figure 1. PROCLAIM Study Screening Timeline from 2018–2022.
Timeline depicting the number of patients screened (yellow), identified as eligible based on pre-screening (green) and enrolled (indicated by the blue triangles) on a monthly basis during the screening period starting in December 2018 and ending in February 2022 (left y-axis). The total COVID-19 cases in the United States per 100,000 population per month is depicted in gray starting in March 2020 (right y-axis). Significant changes to the study protocol are marked by black arrows and the associated protocol version number at the respective months these amendments were approved. Site closures (no patients were screened or enrolled at the site) resulting from the COVID-19 pandemic are depicted at the top of the timeline for the University of North Carolina at Chapel Hill (light blue) and Washington University in St. Louis (red) with their respective logos and corresponding lines marking the duration of study site closure and the reopening of UNC in November 2021.