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cowtown jay

09/12/21 4:41 PM

#33323 RE: ohm20 #33320

"9.3.7 Planned Interim Analyses
A DSMB will monitor ongoing results to ensure subject well-being and safety as well as study
integrity. The DSMB will be asked to recommend early termination or modification only when
there is clear and substantial evidence of a treatment difference."

pg 37 of 101

https://fnih.org/sites/default/files/2021-04/activ-5.pdf

This may be where that conclusion came from. It was not my conclusion initially.