Question about ICH M13a [Regulatives / Guidelines]

posted by Relaxation  – Germany, 2025-11-20 09:47 (220 d 16:23 ago) – Posting: # 24510
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Dear J.

Just very briefly, your second option is the one to use, so "just" remove the treatments that are not of interest from the data set.

Thinking about it, maybe the first option may give the same information, but I would have to try that in a dummy data set. I think, even if that works, the other treatments may still be mentioned in the SAS output as levels then, which would certainly trigger questions.

In any case, the last option including changes in the sequence or even period allocation for me seems risky and was also recommended against (Not sure, whether this was in a guideline, but it was discussed (edit: and advised against) when the EMA-IR was introduced at the 3rd EGA conference, if you want to search for that).

Best regards!

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