ы

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Note added at 34 mins (2008-11-22 16:41:25 GMT)
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For all the other variables an analysis of variance (ANOVA) was used to detect difference between the two treatment groups. The efficacy analysis was performed on the “per protocol set” defined as the **subset of subjects fully compliant with the protocol**
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=17...

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Note added at 39 mins (2008-11-22 16:46:36 GMT)
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The "per protocol" set of subjects is sometimes described as the "valid cases" or "efficacy" or "evaluable subjects" sample. It refers to a subset of subjects **in the full analysis set** who are ****compliant with the protocol****

http://books.google.com/books?id=VlQpUtX3ChwC&pg=PA218&lpg=P...

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Note added at 1 hr (2008-11-22 17:41:23 GMT) Post-grading
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А мне кажется, Павел, здесь можно (нужно?), всё же, не детализировать степень (подробности) "соблюдённости" этого протокола... Достаточно сказать, что "не нарушали", "в целом, соответствовали", "следовали протоколу" и т.п. (см. пару примеров ниже).


The therapeutic response at Day 28 of follow-up with its corresponding 95% confidence intervals was calculated on subjects who **adhered to the protocol** for each study group ("per protocol analysis").
http://www.malariajournal.com/content/6/1/25

The efficacy analysis was primarily assessed in the **per-protocol set** (patients with ****no major protocol deviations****), and then verified in the intent-to-treat (ITT) set (patients with efficacy data) and total set (all randomised patients).
http://bjo.bmj.com/cgi/content/full/91/5/667