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Further studies are needed to explore whether the benefits observed in rodent models translate to human PH, particularly in patients with advanced RV dysfunction
A TGA spokesperson added that while anyone can search the publicly available Database of Adverse Events Notifications, reporting of an adverse event does not necessarily mean that a causal link with the medicine is established
Second, although the CVOTs in general included a meaningful count of people with type 2 diabetes and HF at enrolment, the definition of HF was somewhat vague and varied across the trials
10.1016/j.celrep.2014.10.032 16 Da SilvaR
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