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The FDA panel has deferred the approval of the drug, pending the conduction of a long-term study demonstrating cardiovascular safety [243] (Table 3 )

Additionally, nutritional deficiencies that sometimes accompany rapid weight lossparticularly iron deficiencycan result in low hemoglobin levels (below 12.5 g/dL for women and 13.0 g/dL for men), another common reason for temporary deferral

NaBPC157 significantly prevented the development of liver necrosis or fatty changes in rats subjected to 24 hour bile duct and hepatic artery ligation, 48 hour restraint stress, and CCl 4 treatment (1 ml/kg i.p., sacrifice 48 hours thereafter)

Those who have had a gastric bypass or other bariatric surgery [*]