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Risk factors include atherosclerosis, heart failure, arrhythmias, vasculopathies, aortic surgery, and hypercoagulability
What approval requires: Completion of Phase 3 clinical trials demonstrating safety and efficacy, submission of a New Drug Application (NDA) to the FDA, review and approval process that typically takes 6-12 months after submission
An Allergic Reaction to Detoxification: Very rarely, first-time users often encounter an initial detoxification reaction as the body begins to self-cleanse itself from all the harmful bacteria or toxins residing in the body for a long time
Patients received the lowest effective dose and increases were only considered if they had stopped making progress
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