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Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy
This study will investigate the efficacy, safety, and tolerability of an oral dose of 20 mg or 80 mg tafamidis meglumine soft gel capsules in comparison to placebo and given once daily, in addition to standard of care, for 30 months in subjects diagnosed with transthyretin cardiomyopathy (familial and wild-type). The study is designed to assess the potential for benefit from treatment with tafamidis relative to placebo based on all-cause mortality and frequency of cardiovascular-related hospitalizations.