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Reply from the Authors to Drs. Milanese, Savettieri, and Terzian: Table 4mentions a total of 154 dropouts in the study (49 + 57 + 48), and this term, as noted in the table, included those who completed the 2- and 3-year protocol but chose not to continue in the blinded trial. [2] The table notes that 166 patients completed the fourth year, and entered the fifth year. The "missing" patients (372 - 154 = 218; 218 - 166 = 52) that concern Dr. Milanese and her colleagues are 52 patients who did not complete the fourth year because they entered the open-label treatment phase. In January 1993, the safety monitoring committee recommended that all patients be given the option of taking interferon beta 1b treatment. These 52 patients were late enrollees in the trial (patient accrual had been gradual during 1988 and …
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