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Repeated-dose 90-day Oral Toxicity Studies on Whole ... - Europabio

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4. Provisos for power<br />

analyses<br />

• Power investigati<strong>on</strong> for 3-treatment group scenario<br />

comparing c<strong>on</strong>trol with mean of high and low <str<strong>on</strong>g>dose</str<strong>on</strong>g>s<br />

assumes that, in reality, mean of low <str<strong>on</strong>g>dose</str<strong>on</strong>g> = mean<br />

of high <str<strong>on</strong>g>dose</str<strong>on</strong>g>.<br />

• Power investigati<strong>on</strong> for the 4-treatment group<br />

design assumes that there is no interacti<strong>on</strong> between<br />

treatment (i.e. GM vs. n<strong>on</strong>-GM) and incorporati<strong>on</strong><br />

rate.<br />

– Analysis of previous data indicates that this<br />

assumpti<strong>on</strong> should typically hold in practice.<br />

36

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