2.2. Inclusion/Exclusion Criteria
alcohol abuse, fibroids
FIBROIDS, LIVER DISEASE
The goal of the inclusion and exclusion criteria was to identify non-pregnant or lactating women between the ages of 18 and 40 years old inclusively with or without fibroids. Subjects agreed to use barrier contraception throughout the duration of the study and were not users of hormonal medications, including oral contraceptives, nor of supplements with green tea extracts. Since this safety trial monitors liver function tests, subjects having any known liver disease, or a history of alcohol abuse were excluded from the study.