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Specifically, the acceptable limits were defined as precision (CV) 15% and accuracy (recovery) within 85115% for medium and high concentration levels, with slightly wider limits (CV 20%, recovery 80120%) permitted at the low concentration levels close to the LOQ

[1] [2] However, these studies were limited by small sample sizes, short duration, and lack of long-term safety data

Optional 4 week break after week 12, then resume at maintenance dosing