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It has some rare risks, like lactic acidosis, especially in patients with renal impairment and vitamin B12 deficiency
While these clinical changes can have multiple causes, they warrant medical evaluation, particularly if they coincide with known temperature excursions
Under 35 USC 156, the holder of a patent claiming an approved drug substance can apply for a PTE of up to five years to compensate for regulatory review time lost during the FDA approval process
This approval reflects the commitment to patient safety, providing you with confidence in your choices
doi:10.1186/s12958-018-0323-4 [51] Venkatesan P
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