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The human studies only contained a small number of subjects and often lacked data on factors with a potential impact on neonatal outcomes such as BMI, age, smoking, drug treatment characteristics (dose and administration time) and trimester of exposure

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The study's own modelling shows response depends strongly on sex, drug type, dose, and time on treatment

Others contend that any documented patient need, including needle phobia or B12 deficiency, justifies the compounded formulation

High out-of-pocket costs, complex cost-sharing structures, and gaps in prescription drug coverage are major healthcare policy barriers to medication use in underserved and older patient populations

Mild nausea is expected and manageable