Marie S
If the vial is a bacteriostatic preparation (containing benzyl alcohol), it can be stored and accessed for up to 28 days after the initial puncture, provided it is kept under proper storage conditions
A negative vote typically results in the FDA issuing a final determination against listing, leaving the gray market as the only practical source though rejected substances can be re-nominated in future cycles or challenged in federal court
Statistical analysis Assuming a proportion of participants experiencing overcorrection based on previous literature 13,16,21 , we determined that a sample size of 66 participants would yield 80% statistical power to detect a significant difference in the incidence of overcorrection between the proactive and reactive groups, employing an alpha () level of 0.05, beta () of 0.2, and accounting for a 10% dropout rate
For those considering AOD-9604 , realistic expectations remain essential
Pre-publication history The pre-publication history for this paper can be accessed here: Additional information Competing interests The authors declare that they have no competing interests
