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In the rabbit EFD study, lower fetal body weights (9% decrease) were observed at 1,000 mg/kg/day in the absence of significant maternal toxicity findings

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Participants receiving the highest doses experienced average weight loss of 1522% of their starting body weight, compared to 23% in placebo groups

Persistent severe symptoms that interfere with daily activities or lead to dehydration should prompt immediate medical consultation, as medication discontinuation or alternative treatments may be necessary