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Re: sunspotter post# 223851

Wednesday, 04/11/2018 7:20:33 AM

Wednesday, April 11, 2018 7:20:33 AM

Post# of 403079
How sleazy is this?: In slimy SOM clinical trials land the word modified is given already in trial protocols. It is nearly unavoidable result from eligibility criteria that can be checked only after treatment: minimum cumulative radiation dose on tumor or oral cavity.

All screened and randomized subjects are by definition members of intent to treat group (ITT). In a typical SOM trial some subjects will not reach the cumulative radiation dose required in a trial protocol and will be excluded from efficacy analysis. Modified intent to treat group (mITT) is the group of subjects which did reach the required radiation minimum.

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