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Effects on curvature and plaque were not evaluated in the randomized phase but curvature improvements were noted in 23% of patients and plaque reductions in 47% of patients in the open-label phase

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185 Another study reported symptom improvement in 89.6% of patients (56.3% reported marked improvement, 20.8% moderate, and 12.5% mild improvement)

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a Simultaneous participation in any other clinical trial receiving an investigational medicinal product b Patients who attended the final scheduled visit c Patients who completed treatment with assigned treatment according to the end-of-trial form Note: Rescue medication = use of new anti-diabetic medication as add-on to treatment and used for more than 21 days with the initiation at or after randomization and before last day on treatment Table 25: Patient Disposition (CVOT) CV = cardiovascular