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Every production lot is independently tested for sterility, endotoxins, benzyl alcohol concentration, and pH, with a lot-specific certificate of analysis available for verification

Clinical trials noted a dose-dependent increase in heart rate , peaking at an average of 5 to 10 beats per minute (bpm) around week 24

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Concurrently, explaining the devices principles, benefits, and risks to patients and obtaining their informed consent constitutes an indispensable aspect of clinical rollout