<qa>  What is the OUTLINE of a randomized, double-blind, placebo-OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to menopausal status premenopausal vs postmenopausal and history of breast cancer no history of breast cancer vs history of estrogen receptor ER positive breast cancer vs history of ER negative breast cancer. Patients are randomized to 1 of 2 treatment arms. 