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Supplies Needed Plan based on an 816 week daily protocol with phased dosing (averaging ~700 mcg/day over the cycle)

This screening is a fundamental safety measure and should be documented in the patient's medical records

Method validation LOD and LOQ According to the guidelines for biological sample analysis 37 , the limit of detection (LOD) and limit of quantification (LOQ) are defined as the lowest concentrations giving the signal/noise ratio of 3 and 10, respectively