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however, because of the relatively small number of patients treated, the lack of long-term follow-up data on large numbers of patients, and the potential for serious AEs (e.g., immunosuppression, nephrotoxicity), the Panel judged some uncertainty remains in the balance between benefits and risks/burdens

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A phase 2a clinical trial in patients with atherosclerotic renal artery stenosis undergoing stent revascularization demonstrated that SS-31 infusion before and during the procedure attenuated post-procedural kidney hypoxia, increased renal blood flow, and improved kidney function as measured by cortical perfusion and glomerular filtration rate at three-month follow-up

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