Patients
Between 8 September 2020, and 7 January 2021, 66 patients were screened, of whom 52 were enrolled in the study, with 27 in cohort 1 and 25 in cohort 2, all of whom were included in the full and safety analysis set. On Jan. 31, 2021, the protocol was amended to include 13 additional patients in the cohort 1 and 7 in the cohort 2, giving a total of 40 patients in cohort 1, 32 patients in cohort 2. One of the reasons for the protocol amendment was that too many patients had the desire to participate to this trial and that some of the patients consented before enrollment was halted because of encouraging results of previous enrolled patients in cohort 1 and cohort 2 (Supplementary Table 