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  • Extended-interval dosing of...
    Foley, John F; Campbell, Nolan; Kong, George

    Lancet neurology, March 2023, 2023-03-00, 20230301, Letnik: 22, Številka: 3
    Journal Article

    ...we did not exclude this patient from the primary endpoint analyses for two reasons: the prespecified statistical analysis plan made no allowances for patient exclusion, and a possible multiple sclerosis origin of the T2 lesions at week 48 could not be ruled out on the basis of the lesion characteristics. Because this patient contributed to analyses under both the primary and secondary estimands, we provide reanalysis of both results. The results of our analyses of these exploratory endpoints were presented at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis.2 These results show that there were no differences in MRI volumetric measures between the two dosing groups in NOVA and help provide a more complete understanding of the effectiveness of 6-week dosing of natalizumab for the treatment of patients with relapsing-remitting multiple sclerosis.