(MedDRA) System Organ Class and Preferred Term and summarized by frequency and severity. The severity of an AE was categorized as mild, moderate, or severe based on whether it interfered significantly with the patient's normal functioning.
RESULTS
Patients
Of the 55 patients enrolled, 28 (50.9%) were male, and 52 (94.5%) were White, with a mean ± standard deviation (SD) age of 48.6 ± 15.3 years. The demographic and baseline characteristics of the ITT population are summarized in Table 1. At week 28, 52/55 (94.5%) patients were available for efficacy assessments. Safety assessments included all 55 enrolled patients. One patient discontinued due to a TEAE.
