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A total of 48 patients were screened and 44 patients were randomized (20 patients to garetosmab and 24 patients to placebo). One patient from the garetosmab group discontinued from the study in period 1 due to a TEAE of pyrexia and four patients discontinued during period 2/period 3 due to potential risks associated with the COVID-19 pandemic (n = 1) and a lack of perceived benefit (n = 3). As of the final database lock (20 October 2021), five patients had died. Period 3 was the open-label extension portion of the trial that extended beyond 56 weeks. a Patient died beyond period 3 (after week 76). b These patients decided to withdraw from treatment due to lack of perceived benefit compared to the AE experienced. Both patients continued for safety follow-up.
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