Statement: Cohort 2 in the primary trial and the secondary trial but receive daily placebo doses.
Primary_evidence: INTERVENTION 1:    Treatment Gel + Oral Placebo   4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.   oral placebo: Oral placebo taken daily for 4-10 weeks.   afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks. INTERVENTION 2:    Placebo Gel + Oral Treatment   Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).   tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.   placebo gel: Placebo gel applied to breasts daily for 4-10 weeks.
Secondary_evidence: INTERVENTION 1:    Flaxseed   Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily. INTERVENTION 2:    Placebo   Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.