Fig. 1.

The clinical trial comprised of three sequential periods: high-dose therapy for 3 months (150 μg twice daily every other week), low-dose therapy for 3 months (150 μg once daily every other week) and observation for 18 months. Study visits during treatment were designed at 0, 3 and 6 months. Thereafter, patients were followed up with using visits at 9, 12, 18 and 24 months. Patients’ safety questionnaires were reviewed by telephone at 1. 15 and 21 months