Figure 1.

Study design—Label comprehension assessment (by healthcare professional): questionnaire for healthcare professionals regarding patient training and ability to self-inject using the device following training at V1. Label comprehension assessment (by patient): examination of patients’ retention and comprehension of training received at V1. Screening: 14 days prior to V1; V1: Visit 1 (Day 1); V2: Visit 2 (Days 8–10 or Days 9–11 for the pharmacokinetic study population).