2.2. Study design and treatment
nose symptoms, fever
DLE
This was a prospective, open-label, non-controlled trial. The standard treatment was continued without any modifications, and DLE (Transferon OralPatients responded to each of the 28 items in the 7-domain questionnaire on a scale of 0 (no affection) to 6 (very bothersome). The total score was calculated from the average score of all items. The scores from each of the 7 domains (activity limitation, sleep problems, nose symptoms, eye symptoms, non-hay fever symptoms, practical problems, and emotional function) were obtained from the average score of the items in each domain. The scores for each item were also obtained. The primary endpoint was a change from baseline in the RQLQ overall scores, domain scores, and individual item scores of at least 0.5, minimal important difference (MID).All patients who underwent DLE signed an informed consent form as part of the IC 13-001 approved by the University Ethics Committee. Patients younger than 18 years also provided oral assent.