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Results: At this interim analysis, 306 sufferers had entered the extension study of whom forty three.8% had discontinued for the next reasons: lack of efficacy (1.6%), opposed occasions (9.8%), misplaced to follow‐up (6.2%), protocol violation (6.2%), withdrawal of consent (15.four%), for different reasons (four.6%); seventy eight patients (25.5%) have been nonetheless ongoing. Introduction: The goal of this interim analysis was to guage the lengthy‐

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