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Mean Responses on PGI-Improvement Primary Endpoint at Week 12

Duloxetine. Placebo. Mean Responses on PGI-Improvement Primary Endpoint at Week 12. Very much better 1. Much better 2. ***. ***. ***. ***. A little better 3. No change 4. 2. 4. 8. 12. A little worse 5. Week of Study. Much worse 6.

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Mean Responses on PGI-Improvement Primary Endpoint at Week 12

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  1. Duloxetine Placebo Mean Responses on PGI-Improvement Primary Endpoint at Week 12 Very much better 1 Much better 2 *** *** *** *** A little better 3 No change 4 2 4 8 12 A little worse 5 Week of Study Much worse 6 Very much worse 7 ***P<0.001 vs placebo PGI=Patient Global Impression. At week 12 57% of duloxetine patients who had a PGI-I score ≤2, which was significantly more than patients in the placebo group.

  2. 17.0 17.1 15.4 15.3 13.2 12.9 13.7 13.6 12.4 12.5 Duloxetine Placebo LOCF Mean Change from Baseline to Endpoint in MFI Subscale Scores Baseline: Improvement ** *** ** * ** General Fatigue Physical Fatigue Mental Fatigue Reduced Activity Reduced Motivation * P≤ 0.05; ** P≤ 0.01; *** P≤ 0.001 LOCF= last observation carried forward; MFI= Multidimensional Fatigue Inventory. There were no significant between-treatment differences at baseline.

  3. Baseline: 15.8 16.3 12.4 13.3 Improvement Duloxetine Placebo ** Beck Depression Inventory Beck Anxiety Inventory LOCF Mean Change from Baseline to Endpointin Beck Depression and Anxiety Inventories ** P<0.01 vs placebo LOCF= last observation carried forward.

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