Group Effect in Full Replicate Design [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2018-09-12 15:09 (1232 d 20:08 ago) – Posting: # 19276
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Hi Gm,

» We don't want to take any decisions on the basis of model terms.

Very good.

» Our thought is, we need to check group effect for both ABE and RSABE also.

Again: you have to include “group” as a factor in various ways (see below).

» If this correct, how the model is to be designed for RSABE?

As I wrote above

» » Honestly, I have no clue how to modify the models given in the progesterone-guidance.

Specifically the scaling-part…
For the ABE part (if swR <0.294) like the FDA’s Model II:

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