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Approximately 75% of drug reactions result in the need for liver transplantation or death

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"With the socioeconomic constraints, the cost variables that are at play, we have huge concerns that a large percentage of our patient base that is reliant on compounded formularies that you can get for $100 to $200 a month and now they are faced with having to pay $1,000, we're concerned about where those patients are going to go," he said

If maximum tolerable dose is already used, then consider switching to an alternative obesity medication, adding intensive lifestyle therapy, combining obesity medications, or referring to metabolic-bariatric surgery

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In case non-inferiority is reached at the end of the study, a statistical testing for superiority (cardiovascular benefit of the tested novel substance) can be performed