The following changes made to the P3 trial suggests it was made at the request of the FDA. This could've also been the reason for the lengthy IND delays, the back and forth around use of 2 mg vs 1.5 mg. A real shame.
https://classic.clinicaltrials.gov/ct2/history/NCT04809376?A=1&B=2&C=Side-by-Side#StudyPageTop
The following changes made to the P3 trial suggests it was made...
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