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ARA-290 (12037) ARA 290 (260256) ARA-290 (251426)

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Weight gain is not commonly reported as a side effect of Montelukast

Fumonisin (FB1) could also increase the ROS levels of cells by affecting the Keap1-Nrf2 pathway-related factors to cause inflammation and cell apoptosis, and finally destroy the testicular tissue structure and affect the formation of sperm [87]

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Response: We appreciate commenters' concerns regarding our proposal to grant ECEs to hospitals, REHs, and ASCs that have not requested an ECE but were subject to an extraordinary circumstance affecting their region or locale