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Table 1.

Comparative logistics of phase III trials in different IEN risk settings

SettingCancer riskPrevalence (%)Accrual (y)nDuration (y)
Low risk (e.g., all oral IEN) 10% in 10 y 100 3,204 10 
Moderate risk (e.g., dysplastic oral IEN) 35% in 10 y 10-15 852 10 
Moderate to high risk (e.g., oral IEN with LOH) 35% in 3 y 28 580 
High risk (e.g., post-cancer oral IEN with LOH) 65% in 3 y 66* 300 
SettingCancer riskPrevalence (%)Accrual (y)nDuration (y)
Low risk (e.g., all oral IEN) 10% in 10 y 100 3,204 10 
Moderate risk (e.g., dysplastic oral IEN) 35% in 10 y 10-15 852 10 
Moderate to high risk (e.g., oral IEN with LOH) 35% in 3 y 28 580 
High risk (e.g., post-cancer oral IEN with LOH) 65% in 3 y 66* 300 
*

Prevalence of 3p14 and/or 9p21 LOH in IEN developing in post-treatment oral cancer patients.

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