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In this 13-week double-blind trial, patients were at least 40 years of age without a current diagnosis of major depressive disorder; with no confounding painful conditions or diagnosis of inflammatory arthritis or autoimmune disorders; and with no invasive therapy of the knee in the past three months, knee arthroscopy within the past year or joint replacement of the index knee at anytime. Patients were randomized to duloxetine n128 or placebo n128 and stratified by whether or not they used nonsteroidal anti-inflammatory drugs. At week seven, patients who showed suboptimal response to the 60 mg 33 patients dose had their dose increased to 120 mg. The primary efficacy endpoint of the study was the Brief Pain Inventory BPI 24-hour average pain rating, which was analyzed using a mixed-model repeated measures MMRM approach. Secondary outcomes included the BPI-Severity and Interference items, weekly mean of the 24-hour worst pain and average pain scores, response rates on BPI average pain and weekly 24-hour average pain, the Patient Global Impressions of Improvement, the Western Ontario and McMaster Universities Index WOMAC total and subscales, Clinical Global Impressions of Severity, health survey Short Form-36 SF-36 and EuroQoL Questionnaire - 5 Dimension. Before having surgery, tell your doctor or dentist about all the products you use including prescription drugs, nonprescription drugs, and herbal products.
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