Potvin C in the EU [Two-Stage / GS Designs]

posted by ElMaestro  – Belgium?, 2013-04-17 02:31 (2669 d 14:55 ago) – Posting: # 10425
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Hi Hötzi,

» new experiences from an ongoing MRP. Two studies (first one in two groups due to logistic reasons), Method C (!), all metrics in both studies passed in stage 1 (>80% power in the interim, no α-adjustment = 90% CIs).

Ahhh... MRP - a relic from the bygone ages when your grandad walked around in the snowy alps with bow and arrows looking for deer.

» Studies’ models in stage 1:
  1. Fixed:  sequence, period, treatment, group, group × treatment
    » Random: subject(sequence)
    »
  2. Fixed:  sequence, period, treatment
    » Random: subject(sequence)
Accepted by Germany (RMS); no comments from Austria, Denmark, Sweden, and The Netherlands. Spain: “Statistical analysis should be GLM. Please justify. Please provide the NOL.”
» OK, I will repeat the analyses with all fixed effects (sigh; identical CIs…). ;-)

Anything to please the assessor. I have a feeling the assessor means LM but might not know what that really means since every LM in SAS is done via PROC GLM.
But honestly, group x treatment?? I'd rather not go down that road. I hope you do not make precedence.

» BTW, does anybody know what “NOL” means?

I am fairly sure it is either "No Objection Lertificate" or "Nixon's Obstructive Leprosy". I don't see what else it could possibly be.

I could be wrong, but...

Best regards,
ElMaestro

"Pass or fail" (D. Potvin et al., 2008)

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