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

posted by Helmut Homepage – Vienna, Austria, 2013-04-16 17:40  – Posting: # 10424
Views: 36,057

Dear all,

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).

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…). ;-)
BTW, does anybody know what “NOL” means?

P.S.: All metrics would have passed with αadj 0.0294 (Method B) as well. I did not report these results and interestingly surprisingly was not asked for them.

Cheers,
Helmut Schütz
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