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As per the regulators Complete Response Letter, the FDA asked for additional evidence to confirm the efficacy and safety of glepaglutide at its proposed dose and recommended that Zealand run another clinical trial to generate these data

For instance, it has been reported that hypothyroidism-induced dysfunction of the mitochondrial respiratory chain is associated with increased production of free radicals (59) Thus, excess TSH in hypothyroidism may modulate oxidative stress processes (60) by augmenting the accumulation of ROS that result from both increased generation of free radicals and diminished capacity of the antioxidative defense systems

Glutathione: subcellular distribution and membrane transport (1)