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Based on 62 months median duration of follow-up in the randomized Letrozole arm in the Safety population the incidence of new fractures at any time after randomization was 13. The incidence of new osteoporosis was 14. During treatment or within 30 days of stopping treatment (median duration of treatment 60 months) the incidence of cardiovascular events was 9. Based on 62 months median duration of follow-up in the randomized Letrozole arm in the Safety population the incidence of cardiovascular disease at any time after randomization was 14. Lipid substudy: In the extended adjuvant setting (MA-17), based on a median duration of follow-up of 62 months, there was no significant difference between Letrozole tablets and placebo in total cholesterol or in any lipid fraction over 5 years. Use of lipid lowering drugs or dietary management of elevated lipids was allowed. First-Line Treatment of Advanced Breast Cancer. 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