Studie zur Vorbeugung von
Darmpolypen mit Grüntee-Extrakt

Drop-out criteria

In the following situations, no study enrollment after the run-in is foreseen:

• If the pill count after the run-in period contains more than 30 capsules (out of 70 capsules).

• If the liver enzyme parameters are elevated above 2.5-fold of the upper normal value.

• Study participation will be terminated in the following occasions:

• in the case of any severe adverse event impairing further participation in the study

• If the adherence to study medication is poor (if > 35% of the capsules were not taken during more than one study period)

• the regular intake of the capsules is not assured, for any reason

• it becomes evident after the enrollment that the inclusion criteria have not been fulfilled

• a continuous (longer than 3 months) intake of the following drugs has become necessary: Any NSAID including COX-2 selective NSAIDs and ASS in a dose higher than 100 mg

• the patients desires to exit the study

• The liver enzyme parameters are elevated more than 2.5-fold of the upper normal value.

It is intended to include the data of the follow-up colonoscopy in the subjects that have dropped out for the intention-to-treat analysis.

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