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That process includes large randomised controlled trials demonstrating safety and efficacy, inspection and approval of the specific manufacturing facilities, a standardised and fixed formulation, defined stability and impurity testing, validated supply-chain controls, and ongoing post-market surveillance for adverse events

Blood pressure may begin to decrease in hypertensive patients, and a small increase in heart rate is common

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It would certainly never be freely available without prescription. The journals editorial board called the drugs apparent safety deceptive. They pointed out that not much more than the recommended maximum daily dosage could cause liver damage and that acetaminophen poisoning was already one of the commonest causes of liver failure in Britain