TP0001 study design. Star denotes occurrence of Data Monitoring Committee meeting: safety data review of at least 6 patients in each dose cohort occurred before opening subsequent dose cohorts. In total, 127 patients were screened, 61 patients did not qualify according to the screening results (1 because of an AE, 48 because of ineligibility, 3 because consent was withdrawn, and 9 for other reasons). Overall, 66 patients were enrolled of whom 65 (98.5%) completed the study; 1 patient discontinued because of lack of efficacy. SC, subcutaneous.