3.3. Safety and Tolerability
INJECTION SITE REACTION
Overall, the 82 patients received 232 injections (16 via IM administration; 216 via SC administration). The most common AEs were injection site reactions (For the transrectal ultrasound (TRUS) assessment in clinical trial ARD-0301-008, a statistically significant mean change from baseline to the final assessment of −10.3 (95% CI: −19.9, −0.6) cm