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The supplemental approval was granted based on data from the Phase III EMBARK trial, which studied Xtandi plus leuprolide, placebo plus leuprolide (a synthetic hormone regulator) and Xtandi as a monotherapy

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Major medical groups, including the American College of Obstetricians and Gynecologists (ACOG), still consider acetaminophen the safest option for treating pain or fever in pregnancy, when its used at the lowest effective dose for the shortest necessary time

Whether other combinations with compounds like BPC-157 or TB-500 would provide additional benefits has not been studied