The primary outcomes were change from baseline (measured over 2-week run-in period) to 3, 6, and 12 months (each measured for 4 weeks) and change from baseline to the average for all follow-ups with regard to the mean frequency and intensity of vasomotor symptoms (daytime hot flashes plus night sweats) and the mean Wiklund Vasomotor Symptom Subscale score (11–12). We also evaluated change from baseline to follow-up (months 3, 6, and 12 and average change) for daytime hot flash rate, night sweat rate, and the total Wiklund Menopause Symptom Scale score. Symptom diaries and global ratings of menopause symptoms are almost universally used in studies of vasomotor symptoms. Participants used a vasomotor symptom diary to record daytime hot flashes and night sweats, rating intensity as mild, moderate, or severe (scale, 1 to 3), as recommended by the U.S. Food and Drug Administration (13). Women completed the Wiklund Menopause Symptom Scale, rating the severity of 13 menopausal symptoms (sweats, hot flashes, sleep disturbance, fatigue, vaginal dryness, depression, headache, irritability, muscle/joint pain, breast tenderness, nervousness, palpitations, and dizziness/fainting on a scale of 0 (none) to 10 (severe) (11). Soy food intake was monitored by using a self-reported, validated soy food questionnaire (14).