GPT and Stroke: The study drug will be discontinued if a participant meets any of the following criteria: neurologic dysfunction or development of stroke, allergic reaction to the study drug, participant or caregiver request, or abnormal lab results including an alanine transaminase (ALT) level > 6 times the upper limit of normal, a creatinine level of > 1.2 mg/dL, or acidosis (i.e., bicarbonate < 16 mEq/L).