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Re: Vanilla Fitbit post# 36417

Tuesday, 02/23/2021 5:32:41 PM

Tuesday, February 23, 2021 5:32:41 PM

Post# of 44690
The biggest changes were here using the compare 'side by sides, 60 day change as secondary outcome with different endpoints. Some tweaking since.

https://clinicaltrials.gov/ct2/history/NCT04311697?A=15&B=16&C=Side-by-Side#StudyPageTop

A look at Rem results. They stayed with the WHO scale and had <12% effect in the randomized evaluations for 397 of 4800 total patients. Look at all the Sites they took, world wide CASH / BP has influence. Also TEAEs seem high.

https://clinicaltrials.gov/ct2/history/NCT04292899?A=9&B=21&C=Side-by-Side#StudyPageTop