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Given that such data are not entirely homogenous with RCTs in terms of design and control conditions, they are best utilized as exploratory indicators of “potential effect ceilings and accessibility” to calibrate clinical expectations, rather than as direct points of comparison for placebo-controlled RCTs

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The regulator is also asking the drugmaker to carry out a clinical pharmacology trial using ultrasound to measure the effects of both temporary withholding of Foundayo and fasting duration on retained gastric contents, to see if it can lead to gastroparesis – a potentially serious side effect that can lead to vomiting and entry of stomach contents into the airway