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Re: frrol post# 452670

Saturday, 02/24/2024 5:53:58 PM

Saturday, February 24, 2024 5:53:58 PM

Post# of 462040
According to clinicaltrials.gov the first trial description had CGI-I as secondary outcome version 1. The first trial update after that had CGI-I as co-primary. version 2
It stayed co-primary until the September 27 2021 trial update and it was switched back to secondary outcome. That was version #8

From September 27th 21 up onward CGI-I remained in secondary outcomes through the final version #17.

The Sept 27th 21 update showed that the changes were "Outcome Measures, Study Status, Eligibility, Study Description, Contacts/Locations, Study Design and Study Identification"

It was the first update that made what appears to be an error. The changes for that update were listed as "Arms and Interventions, Contacts/Locations and Study Status". Notice that outcome measures was not listed as a change. It appears that the change to CGI-I to primary outcome was an error in the update and that wasn't corrected until the Sept. 27th update. All of the updates between the first on and the Sept 27th update are listed as "study status" or "Contacts/Locations and Study Status" updates.

As for the seizure outcomes information. You assume that it would be disclosed if it was stat significant. The company may not have been analyzing that data at that point, being more concerned with the RSBQ and CGI-I issues.

So you were not quite right about when CGI-I was changed and changed back.

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