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Re: Lykiri post# 539258

Sunday, 11/27/2022 10:49:45 AM

Sunday, November 27, 2022 10:49:45 AM

Post# of 705765

Ex, Wrong!


OK, I'll bite.

You said that in response to my post where I asserted the protocol was change on 9/23/2020:

Documenting the Endpoint Changes:
Update the protocol in a formal protocol amendment. Not done until 9/23/20



I took that straight from the JAMA article at the very bottom of supplement 1.

v7.0, 23 September 2020 Final Protocol


Several changes to conform to the Statistical Analysis Plan
(SAP), dated 23 September 2020
. Primary endpoint: OS for newly diagnosed glioblastoma patients, compared to external controls
. Secondary endpoint: OS for recurrent glioblastoma patients, compared to external controls
. SAP included as Appendix to the Protocol
. The SAP v1.0 governs all analyses for the study



Looks clear to me, but if you see a conflicting source maybe you can post it.
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