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A study from The Netherlands (Riphagen, 2020) found that after 8.5 years of follow-up of an older cohort (median baseline age=65), a doubling of baseline MMA levels was associated with an increased risk of mortality (HR 11.48, CI 3.3239.64)

The application contained data from the Phase III FOCUS study, a single-arm, open-label trial which enrolled 91 patients who were treated every six to eight weeks for up to a maximum of six cycles

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