Trial status
Enrollment for this trial was initiated on November 20, 2019, with enrollment stoppage due to institutional policies related to the COVID-19 pandemic from March 13, 2020, through August 24, 2020, then again on December 2, 2020, through January 29, 2021, at which point enrollment resumed. The interim analysis occurred on August 1, 2022, without meeting a stopping rule. Complete enrollment is anticipated to finish in 2023.