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7. Thomas G, Ali S, Hoebers FJ, et al. Phase III trial to evaluate the efficacy of maintaining hemoglobin levels above 12.0 g/dL with erythropoietin vs above 10.0 g/dL without erythropoietin in anemic patients receiving concurrent radiation and cisplatin for cervical cancer. Gynecol Oncol. 2008;108(2):317-325.

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9. Untch M, Fasching PA, Konecny GE, et al; Arbeitsgemeinschaft Gynäkologische Onkologie PREPARE investigators. PREPARE trial: a randomized phase III trial comparing preoperative, dose-dense, dose-intesified chemotherapy with epirubicin, paclitaxel and CMF versus a standard-dosed epirubicin/cyclophosphamide followed by paclitaxel darbepoetin alfa in primary breast cancer—results at the time of surgery. Ann Oncol. 2011;22(9):1988-1998.

10. Hedenus M, Adriansson M, San Miguel J, et al; Darbepoetin Alfa 20000161 Study Group. Efficacy and safety of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies: a randomized, double-blind, placebo-controlled study. Br J Haematol. 2003;122(3):394-403.

11. Smith RE Jr, Aapro MS, Ludwig H, et al. Darbepoetin alfa for the treatment of anemia in patients with active cancer not receiving chemotherapy or radiotherapy: results of a phase III, multicenter, randomized, double-blind, placebo-controlled study. J Clin Oncol. 2008;26(7):1040-1050.

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13. Overgaard J, Hoff C, Sand Hansen H, el at. Randomized study of the importance of novel erythropoiesis stimulating protein (Aranesp®) for the effect of radiotherapy in patients with primary squamous cell carcinoma of the head and neck (HNSCC)—the Danish Head and Neck Cancer Group DAHANCA 10 randomized trial. Eur J Cancer Suppl. 2007;5(6):7.

14. Henke M, Laszig R, Rübe C, et al. Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double-blind, placebo-controlled trial. Lancet. 2003;362(9392):1255-1260.

15. Bohlius J, Schmidlin K, Brillant C, et al. Erythropoietin or darbepoetin for patients with cancer—meta-analysis based on individual patient data. Cochrane Database Syst Rev. 2009;(3):CD007303.

16. Bennett CL, Silver SM, Djulbegovic B, et al. Venous thromboembolism and mortality associated with recombinant erythropoietin and darbepoetin administration for the treatment of cancer-associated anemia. JAMA. 2008;299(8):914-924.

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21. Questions and answers on the federal register notice on drugs and biological products deemed to have Risk Evaluation and Mitigation Strategies. U.S. Food and Drug Administration Web site. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/ucm095439.htm. Accessed January 3, 2012.

22. ESA APPRISE Oncology Program. Welcome to the ESA APPRISE Oncology Program. https://www.esa-apprise.com/ESAAppriseUI/ESAAppriseUI/default.jsp. Accessed January 3, 2012.

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