I'm not sure how this would fall under a pedantry label. If we are okay assuming that a medication used widely for other age groups is safe for infants, why bot

I'm not sure how this would fall under a pedantry label. If we are okay assuming that a medication used widely for other age groups is safe for infants, why bother with an incomplete study that was never designed to produce statistically significant results? The study is only useful if it can show safety and efficacy of the dosage levels for the test population. I'm not trying to argue that the study was even necessary if the safety and efficacy can be implied, only that if the study is to be done it should at least be setup with a chance of proving the needed results.