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[7] Commonly observed adverse effects include transient injection-site discomfort, breast tenderness, nausea, fluid retention, and mild mood fluctuation, whereas rarer but serious events encompass venous or arterial thromboembolism, gallbladder disease, significant elevation of blood pressure, and hormone-sensitive malignancies such as endometrial or breast cancer

6.1.2.3 Pharmacodynamic findings Further pharmacodynamic analysis evaluated brensocatibs inhibitory effects on different NSPs ( 6.1.3 ASPEN study (phase III clinical trial) 6.1.3.1 Study design and scope Based on positive results from the WILLOW study, Insmed initiated the large-scale Phase III ASPEN clinical trial to further validate brensocatibs long-term efficacy and safety ( 6.1.3.2 Primary efficacy results The ASPEN trial enrolled 1,721 patients across 35 countries to evaluate brensocatibs effectiveness in bronchiectasis management