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A, Risk mitigation approach adopted by the research team, demonstrating risk conferred by the study itself, the SARS-CoV-2 pandemic, controlled and uncontrolled comorbidities. B, Summary of risk mitigation strategy to be implemented by the study. Abbreviations: ATI, analytic treatment interruption; COVID-19, coronavirus disease 2019; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.
