Fig. 2

Figure to show the sequential study design (A) and patient disposition (B). Safety analysis set and ITT population were the same in this study. Per protocol set excluded three patients who received the incorrect dose of study medication at one of the four injections (one patient allocated to placebo treatment arm erroneously received IMCY-0098). ^aPatients were excluded for the following reasons: HLA status (n = 10), withdrawal of consent (n = 7), C-peptide level (n = 3); time post-diagnosis (n = 2), autoantibody status (n = 1) and body-mass index (n = 1). ^bA total of 15 patients were planned for dose C; however, 16 patients were randomized to receive this dose. dose A: 50 μg at week 0 followed by 3 × 25 μg; dose B: 150 μg at week 0 followed by 3 × 75 μg; dose C: 450 μg at week 0 followed by 3 × 225 μg. ITT, intent-to-treat. N/n refer to patients