<p>SUPPLEMENTARY INFORMATION </p><p>Dietary Counseling</p><p>Dietary counseling, including instructions for completing food and activity journals, was provided by a registered dietitian, and dietary guidelines were distributed at the start of the placebo run-in period. The recommended diet was 25% lower in kcal than weight maintenance requirements and contained 55% to 60% carbohydrate, 10% to 20% protein, and not more than 30% fat. Daily energy expenditure was determined using an estimate of basal metabolic rate (BMR) multiplied by an activity factor of 1.3. An exercise regimen was designed for each patient according to the patient’s current level of physical activity and health status. </p><p>Laboratory Assays</p><p>Cholesterol and TG were measured using validated commercial enzymatic colorimetric test kits on automated analyzers. LDL-C was calculated according to the Friedewald equation (LDL-C =</p><p>TC- [TG/5] – HDL-C), a method that is widely used in clinical practice. In patients with elevated </p><p>TG (≥400 mg/dL [4.5 mmol/L]), LDL-C was determined by beta-quantification. FSI, insulin sensitivity (QUICKI), and FPG were measured using validated commercial assays. High-sensitivity-</p><p>CRP was assessed using the nephelometry method. Adiponectin was assessed using an ELISA assay.</p><p>1 Table S1. Patient disposition.</p><p>No. pts screened (N=4106) Taranabant 6 mg Taranabant 2 Taranabant 4 Treatment Placebo (fixed and mg mg titrated) No. Pts randomized 417 414 415 1256 No. Pts who discontinued study medication and entered off study 32 (7.7%) 43 (10.4%) 53 (12.8%) 132 (10.5%) drug phase¶ Discontinued due to clinical AE 13 (3.1%) 26 (6.3%) 31 (7.5%) 91 (7.3%) Discontinued due to lack of efficacy 7 (1.7%) 2 (0.5%) 4 (1.0%) 4 (0.3%) Lost to follow-up 1 (0.2) 0 0 2 (0.2%) Protocol deviation 2 (0.5%) 7 (1.7%) 3 (0.7%) 5 (0.4%)</p><p>Patient withdrew consent 1 (0.2%) 0 0 3 (0.2%)</p><p>Laboratory adverse experience 0 0 0 1 (0.1%)</p><p>Discontinued due to other reason 8 (1.9%) 8 (1.9%) 15 (3.6%) 25 (2.0%) No. Pts who discontinued study medication and dropped out of 188 169 (40.8%) 162 (39.0%) 546 (43.5%) study§ (45.1%) Discontinued due to clinical AE 34 (8.2%) 47 (11.4%) 67 (16.1%) 227 (18.1%)</p><p>Discontinued due to lack of efficacy 19 (4.6%) 8 (1.9%) 3 (0.7%) 12 (1.0%)</p><p>Lost to follow-up 32 (7.7%) 32 (7.7%) 21 (5.1%) 91 (7.2%)</p><p>Patient moved 7 (1.7%) 5 (1.2%) 4 (1.0%) 16 (1.3%)</p><p>Patient withdrew consent 79 (18.9%) 67 (16.2%) 58 (14.0%) 180 (14.3%)</p><p>2 Protocol deviation 9 (2.2%) 4 (1.0%) 5 (1.2%) 9 (0.7%)</p><p>Laboratory adverse experience 2 (0.5%) 1 (0.2%) 0 0</p><p>Discontinued due to other reason§ 2 (0.5%) 2 (0.5%) 1 (0.2%) 7 (0.6%)</p><p>Terminated by sponsor 0 0 0 1 (0.1%)</p><p>Site terminated 4 (1.0%) 3 (0.7%) 3 (0.7%) 3 (0.2%) 197 No. Pts who completed Year 2 202 (48.8%) 200 (48.2%) 578 (46.0%) (47.2%) AE= adverse experience</p><p>3 4 Table S2. Number (%) of patients with metabolic syndrome† at Year 1 (Week 52) and Year 2 (Week 104).</p><p>Placebo Taranabant 2 mg Taranabant 4 mg Year 1 188/396 (47.5%) 138/382 (36.1%)** 121/393 (30.8%)***</p><p>Year 2 129/254 (50.8%) 98/270 (36.3%)** 99/264 (37.5%)***</p><p>***p≤0.001 vs. Placebo; **p≤0.010 vs. Placebo †Patients were classified as having metabolic syndrome if they met at least 3 of the following 5 criteria: (1) waist circumference >102 cm for men and >88 cm for women (2) TG ≥150 mg/dL; (3) HDL-C <40 mg/dL for men or <50 mg/dL for women; (4) seated SBP >130 mm Hg or seated DBP >85 mm Hg; (4) impaired fasting glucose (FPG >100 mg/dL and <126 mg/dL. Includes patients who completed Year 1 and entered Year 2 on the same treatment</p><p>5 Table S3. Assessment of Weight Independent Effects on Change or Percent Change From Baseline in Parameters of Interest at Week 52 (All Patients Treated Population, Using Last Observation Carried Forward)</p><p>Endpoint Treatment Treatment effect Treatment effect Percentage of Total in adjusted model† in unadjusted model‡ Effect Size Not Explained by Weight Loss (95% CI)§ Percent Change in TG Taranabant 2 mg -3.3 (-8.6, 2.0) -11.5 (-16.9, -6.1)*** 28.9 (-30.6, 53.0) Taranabant 4 mg -4.6 (-10.0, 0.8) -15.5 (-20.9, -10.1)*** 29.6 (-7.7, 49.9) Percent Change in HDL-C Taranabant 2 mg 3.4 (1.1, 5.8) 6.1 (3.8, 8.5)*** 55.6 (26.6, 70.4) Taranabant 4 mg 3.4 (1.0, 5.8) 7.0 (4.7, 9.4)*** 48.4 (20.5, 64.6) Percent Change in non- Taranabant 2 mg -0.8 (-3.4, 1.8) -3.3 (-5.8, -0.7)* 24.9 (-222.9, 60.9) HDL-C Taranabant 4 mg -1.9 (-4.5, 0.8) -5.2 (-7.8, -2.7)*** 36.0 (-26.9, 61.2) Change in QUICKI Taranabant 2 mg 0.009 (-0.001, 0.019) 0.014 (0.004, 0.024)** 69.2 (10.8, 87.5) Taranabant 4 mg 0.011 (0.001, 0.021) 0.016 (0.005, 0.026)** 70.2 (13.3, 87.9) Note: * : p-value ≤ 0.050, ** : p-value ≤ 0.010, *** : p-value ≤ 0.001 † Least-squares mean difference from placebo based on ANCOVA model with terms of treatment, region, baseline value, run-in change in parameter, baseline body weight, run-in weight change, weight change at Week 52. ‡ Least-squares mean difference from placebo based on ANCOVA model with terms of treatment, region, baseline value, run-in change in parameter, baseline body weight, run-in weight change. § Confidence interval based on Fieller's method. Note: Missing values imputed using the last post-baseline measurement. CI = Confidence Interval; LS Mean = Least Squares Mean, computed from main effects model.</p><p>6 Table S4. Analysis of change from baseline in the SF36v2 - selected components and domains over 104 weeks of treatment.</p><p>Component/ Time Treatment N Baseline LS Mean LS Mean Difference p-value Domain Mean Change From Placebo (95% Vs. (SD) (95% CI) CI) Placebo Standardized Week Placebo 348 54.1 (7.1) -1.9 (-3.1, -0.7) -- -- Mental 52* Taranabant 2 mg 346 54.1 (7.2) -3.0 (-4.2, -1.9) -1.1 (-2.5, 0.3) 0.110 Taranabant 4 mg 357 54.6 (6.6) -4.8 (-5.9, -3.6) -2.9 (-4.2, -1.5) <0.001 Week Placebo 234 54.3 (7.1) -1.0 (-2.1, 0.1) -- -- 104** Taranabant 2 mg 251 54.5 (7.3) -1.6 (-2.6, -0.5) -0.6 (-2.0, 0.8) 0.404 Taranabant 4 mg 245 54.8 (7.0) -3.1 (-4.2, -2.1) -2.2 (-3.6, -0.8) 0.002 Social Week Placebo 357 91.6 (16.2) -2.8 (-5.2, -0.3) Functioning 52* Taranabant 2 mg 355 92.1 (15.5) -4.2 (-6.6, -1.9) -1.5 (-4.3, 1.3) 0.299 Taranabant 4 mg 36 -7.6 (21.7) -7.1 (-9.5, -4.7) -4.3 (-7.1, -1.6) 0.002 2 Week Placebo 240 91.1 (15.9) 0.6 (-1.7, 2.9) -- -- 104** Taranabant 2 mg 258 92.0 (16.0) -1.7 (-3.9, 0.6) -2.3 (-5.2, 0.7) 0.138 Taranabant 4 mg 249 92.9 (13.6) -2.6 (-4.9, -0.3) -3.2 (-6.2, -0.2) 0.039 Role Week Placebo 355 92.6 (16.5) -2.9 (-5.2, -0.7) -- -- Emotional 52* Taranabant 2 mg 355 93.0 (13.2) -4.0 (-6.2, -1.8) -1.1 (-3.7, 1.5) 0.420 Taranabant 4 mg 362 92.7 (14.3) -7.0 (-9.2, -4.8) -4.1 (-6.7, -1.5) 0.002 Week Placebo 239 92.8 (16.0) -0.8 (-2.9, 1.3) -- -- 104** Taranabant 2 mg 258 93.1 (13.4) -1.6 (-3.7, 0.4) -0.8 (-3.5, 1.9) 0.552 Taranabant 4 mg 249 92.1 (14.6) -3.2 (-5.3, -1.1) -2.4 (-5.1, 0.4) 0.090 Mental Week Placebo 356 83.2 (12.9) -3.0 (-4.9, -1.0) -- -- Health 52* Taranabant 2 mg 354 81.6 (13.8) -4.7 (-6.7, -2.8) -1.8 (-4.1, 0.5) 0.132 Taranabant 4 mg 360 83.3 (12.6) -8.4 (-10.4, -6.4) -5.4 (-7.7, -3.1) <0.001 Week Placebo 239 83.4 (12.7) -1.2 (-3.2, 0.8) -- -- 104** Taranabant 2 mg 257 82.5 (14.1) -2.0 (-3.9, -0.0) -0.7 (-3.3, 1.8) 0.574 Taranabant 4 mg 247 83.9 (13.5) -5.9 (-7.8, -3.9) -4.6 (-7.2, -2.1) <0.001 *: Change from baseline at Week 52 in the all patients treated population with last observation carried forward (LOCF) method. **: Change from baseline at Week 104 in patients who completed Year 1 and entered Year 2 on the same treatment. SD= standard deviation; LS= least squares; CI= confidence interval.</p><p>7 Table S5. Summary of change from baseline in the IWQoL: Physical Function over 104 weeks of treatment.</p><p>Treatment N Baseline LS Mean (95% LS Mean p-Value vs. Mean (SD) CI) Change from (95% CI) Placebo Baseline Difference vs. Placebo </p><p>Change from baseline at Week 52 in all patients as treated population (LOCF) Placebo 303 73.9 (19.5) 10.1 (8.2, 12.1) -- -- Taranabant 2 mg 307 73.0 (19.1) 11.6 (9.8, 13.5) 1.5 (-0.6, 3.6) 0.156 Taranabant 4 mg 302 69.8 (20.2) 13.2 (11.3, 15.1) 3.0 (0.9, 5.2) 0.005</p><p>Change from baseline at Week 104 in patients who completed Year 1 and continued in Year 2 on the same treatment Placebo 204 75.0 (18.9) 13.1 (10.7, 15.5) -- -- Taranabant 2 mg 219 73.4 (19.1) 15.6 (13.3, 17.9) 2.5 (-0.3, 5.4) 0.081 Taranabant 4 mg 205 68.2 (20.3) 13.7 (10.7, 15.5) 0.6 (-2.3, 3.6) 0.677</p><p>SD= standard deviation; LS= least squares; CI= confidence interval</p><p>8 Table S6. Summary of change from baseline in the EuroQoL (EQ5D) over 104 weeks of treatment. Treatment N Baseline LS Mean (95% LS Mean p-Value vs. Mean (SD) CI) Change from (95% CI) Placebo Baseline Difference vs. Placebo </p><p>Change from baseline at Week 52 in all patients as treated population (LOCF) Placebo 361 78.1 (15.5) 2.9 (1.2, 4.6) -- -- Taranabant 2 mg 355 78.5 (15.9) 3.6 (1.9, 5.3) 0.7 (-1.2, 2.7) 0.462 Taranabant 4 mg 358 78.4 (14.9) 3.5 (1.9, 5.2) 0.6 (-1.3, 2.6) 0.521</p><p>Change from baseline at Week 104 in patients who completed Year 1 and continued in Year 2 on the same treatment† Placebo 190 79.0 (14.8) 5.4 (13.9) NA NA Taranabant 2 mg 197 80.0 (16.0) 4.8 (16.8) NA NA Taranabant 4 mg 185 78.9 (14.5) 5.2 (14.0) NA NA</p><p>SD= standard deviation; LS= least squares; CI= confidence interval †Only summary statistics based on observed data were obtained.</p><p>9 Table S7. Discontinuations due to drug-related† clinical adverse experiences reported by at least two patients in any single treatment group in Year 1 and/or Year 2.</p><p>Year 1 Year 2*</p><p>† SOCs and specific drug-related clinical AEs Placebo Taranabant 2 mg Taranabant 4 mg Taranabant 6 mg Placebo Taranabant 2 mg N=264 Taranabant 4 mg N=260 N =417 N =414 N=415 (fixed and titrated) N=1256 N=244 leading to discontinuation Cardiac Disorders 0 1 (0.2%) 1 (0.2%) 3 (0.2%) 0 0 0 Ear and Labyrinth Disorders 0 0 0 3 (0.2%) 0 0 0 Vertigo 0 0 0 3 (0.2%) Gastrointestinal Disorders 2 (0.5%) 6 (1.4%) 10 (2.4%) 39 (3.1%) 0 1 (0.4%) 2 (0.8%) Abdominal pain 0 0 0 2 (0.2%) 0 0 0 Diarrhea 0 1 (0.2%) 1 (0.2%) 8 (0.6%) 0 0 1 (0.4%) Nausea 1 (0.2%) 2 (0.5%) 5 (1.2%) 22 (1.8%) 0 1 (0.4%) 1 (0.4%) Vomiting 0 0 1 (0.2%) 2 (0.2%) 0 0 0 General Disorders and Administrative Site Conditions 4 (1.0%) 6 (1.4%) 6 (1.4%) 16 (1.3%) 0 1 (0.4%) 1 (0.4%) Fatigue 1 (0.2%) 2 (0.5%) 0 3 (0.2%) 0 1 (0.4%) 0 Irritability 2 (0.5%) 2 (0.5%) 6 (1.4%) 9 (0.7%) 0 0 1 (0.4%) Infections and Infestations 0 0 0 2 (0.3%) 0 0 0 Metabolism and Nutrition Disorders 0 0 0 2 (0.3%) 0 0 0 Anorexia 0 0 0 2 (0.3%) 0 0 0 Nervous System Disorders 5 (1.2%) 1 (0.2%) 5 (1.2%) 19 (1.5%) 0 0 1 (0.4%) Disturbance in attention 0 0 0 3 (0.2%) 0 0 0 Dizziness 0 1 (0.2%) 1 (0.2%) 3 (0.2%) 0 0 0 Headache 3 (0.7%) 0 0 3 (0.2%) 0 0 0 Psychiatric Disorders 14 (3.4%) 29 (7.0%) 40 (9.6%) 126 (10.0%) 2 (0.8%) 6 (2.3%) 3 (1.2%) Affect lability 0 1 (0.2%) 3 (0.7%) 4 (0.3%) 0 0 0 Aggression 0 2 (0.5%) 0 1 (0.1%) 0 0 0 Agitation 0 0 1 (0.2%) 5 (0.4%) 0 0 0 Anger 0 1 (0.2%) 0 3 (0.2%) 0 0 0 Anxiety 1 (0.2%) 2 (0.5%) 10 (2.4%) 28 (2.2%) 0 0 1 (0.4%) Anxiety disorder 0 0 0 2 (0.2%) 0 0 0 Crying 0 0 2 (0.5%) 5 (0.4%) 0 0 0 Depressed mood 2 (0.5%) 6 (1.4%) 5 (1.2%) 17 (1.4%) 1 (0.4%) 2 0 Depression 4 (1.0%) 5 (1.2%) 4 (1.0%) 22 (1.8%) 0 1 (0.4%) 2 (0.8%) Depressive symptom 0 1 (0.2%) 4 (1.0%) 5 (0.4%) 0 0 0</p><p>10 Insomnia 2 (0.5%) 1 (0.2%) 0 7 (0.6%) 0 0 0 Major depression 0 1 (0.2%) 4 (1.0%) 4 (0.3%) 1 (0.4%) 0 0 Mood altered 2 (0.5%) 1 (0.2%) 1 (0.2%) 6 (0.5%) 0 0 0 Mood swings 0 1 (0.2%) 0 4 (0.3%) 0 0 0 Nervousness 0 2 (0.5%) 0 4 (0.3%) 0 1 (0.4%) 0 Panic attack 0 2 (0.5%) 3 (0.7%) 2 (0.2%) 0 0 0 Skin and Subcutaneous Tissue Disorders 2 (0.5%) 6 (1.4%) 3 (0.7%) 10 (0.8%) 0 0 0 Hyperhidrosis 0 1 (0.2%) 1 (0.2%) 2 (0.2%) 0 0 0 Pruritus 0 3 (0.7%) 2 (0.5%) 4 (0.3%) 0 0 0 Pruritus generalized 0 0 0 2 (0.2%) 0 0 0 Vascular Disorders 1 (0.2%) 0 1 (0.2%) 3 (0.2%) 0 0 0 Hot flush 0 0 1 (0.2%) 3 (0.2%) 0 0 0</p><p>*Includes AEs reported from Week 52 up to week 104 in patients who completed Year 1 and entered Year 2 on the same treatment. AE = adverse experience SOC = System Organ Class †Determined by the study investigator to be possibly, probably or definitely treatment-related.</p><p>11 Table S8. Summary of change from baseline in Digit Symbol Substitution Test over 104 weeks of treatment. Treatment N Baseline LS Mean (95% LS Mean p-Value vs. Mean (SD) CI) Change from (95% CI) Placebo Baseline Difference vs. Placebo </p><p>Change from baseline at Week 52 in all patients as treated population (LOCF) Placebo 128 56.3 (16.7) 9.2 (5.9, 12.6) -- -- Taranabant 2 mg 134 60.1 (22.2) 4.2 (0.9, 7.5) -5.0 (-8.4, -1.7) 0.003 Taranabant 4 mg 126 57.4 (22.6) 4.9 (1.5, 8.2) -4.4 (-7.8, -1.0) 0.012</p><p>Change from baseline at Week 104 in patients who completed Year 1 and continued in Year 2 on the same treatment Placebo 77 55.6 (13.2) 9.9 (6.2, 13.5) Taranabant 2 mg 92 58.8 (21.1) 7.0 (3.5, 10.4) -2.9 (-6.5, 0.7) 0.115 Taranabant 4 mg 74 57.2 (23.0) 6.9 (3.3, 10.4) -3.0 (-6.8, 0.8) 0.118</p><p>SD= standard deviation; LS= least squares; CI= confidence interval</p><p>12 Table S9. Summary of change from baseline in POMSb: Total Mood Disturbance Score over 104 weeks of treatment.</p><p>Treatment N Baseline LS Mean (95% LS Mean p-Value vs. Mean (SD) CI) Change from (95% CI) Placebo Baseline Difference vs. Placebo </p><p>Change from baseline at Week 52 in all patients as treated population (LOCF) Placebo 125 1.2 (10.2) 3.0 (-0.2, 6.2) -- -- Taranabant 2 mg 133 4.8 (15.8) 2.7 (-0.3, 5.7) -0.3 (-3.5, 2.9) 0.849 Taranabant 4 mg 115 0.9 (9.7) 5.9 (2.7, 9.1) 2.9 (-0.4, 6.2) 0.081</p><p>Change from baseline at Week 104 in patients who completed Year 1 and continued in Year 2 on the same treatment Placebo 74 0.4 (11.0) -0.6 (-5.2, 4.1) Taranabant 2 mg 88 3.6 (14.6) 3.2 (-1.2, 7.6) 3.8 (-0.3, 7.9) 0.069 Taranabant 4 mg 72 0.4 (11.0) 2.7 (-1.9, 7.3) 3.3 (-1.0, 7.5) 0.133</p><p>SD= standard deviation; LS= least squares; CI= confidence interval</p><p>13 Table S10. Summary of change from baseline in self-administered PHQ-9 over 104 weeks of treatment. Treatment N Mean (SD) LS Mean (95% LS Mean p-Value Baseline SF36v2 CI) Change from (95% CI) vs. Standardized Baseline Difference vs. Placebo Mental Placebo Component</p><p>Change from baseline at Week 52 in all patients as treated population (LOCF) Placebo 95 2.2 (2.6) 1.0 (-0.2, 2.2) -- -- Taranabant 2 mg 96 2.2 (2.7) 1.5 (0.4, 2.6) 0.5 (-0.5, 1.5) 0.314 Taranabant 4 mg 91 1.9 (1.9) 2.4 (1.2, 3.6) 1.4 (0.4, 2.4) 0.005</p><p>Change from baseline at Week 104 in patients who completed Year 1 and continued in Year 2 on the same treatment Placebo 61 1.8 (2.2) -0.1 (-1.4, 1.2) Taranabant 2 mg 65 2.2 (2.7) 0.6 (-0.6, 1.9) 0.7 (-0.2, 1.6) 0.134 Taranabant 4 mg 58 1.9 (1.7) 0.4 (-0.9, 1.7) 0.5 (-0.4, 1.4) 0.300 SD= standard deviation; LS= least squares; CI= confidence interval</p><p>14 Study Sites</p><p>Louis J. Aronne, Comprehensive Weight Control Program, New York, NY; </p><p>Stephen Louis Aronoff, Research Institute of Dallas, Dallas, TX; Harold E. Bays, </p><p>Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY; Robert J. </p><p>Bielski, Summit Research Network, Farmington Hills, MI; Bruce Taylor Bowling, </p><p>Regional Clinical Research, Inc., Endwell, NY; George August Bray, Pennington </p><p>Biomedical Research Center, Baton Rouge, LA; Cynthia C. Brinson, Central Texas </p><p>Clinical Research, Austin, TX; Mary E. Bartz, Central Texas Clinical Research, Austin, </p><p>TX; Richard O. Butcher, Careview Medical Group, Inc., San Diego, CA; Rodney G. </p><p>Hood, Careview Medical Group, Inc., San Diego, CA; Robert S. Call, Commonwealth </p><p>Clinical Research Specialists, Richmond, VA; Antonio Caos, Central Florida Clinical </p><p>Studies, Ocoee, FL; Christopher M. Chappel, FPA Clinical Research, Kissimmee, FL; </p><p>Harry Collins, Anderson and Collins Clinical Research, Inc., Edison, NJ; Martin J. </p><p>Conway, Lovelace Scientific Resources, Inc., Albuquerque, NM; Michael H. Davidson, </p><p>Radiant Research, Chicago, IL; Mark A. Deeg, Richard L. Roudebush Veterans Affairs </p><p>Medical Center, Indianapolis, IN; Marian Sue Kirkman, Richard L. Roudebush Veterans </p><p>Affairs Medical Center, Indianapolis, IN; John Howard Pratt, Richard L. Roudebush </p><p>Veterans Affairs Medical Center, Indianapolis, IN; Eleuterio P. Delfin, Jr., Center for </p><p>Clinical Trials, LLC; Paramount, CA; Samuel S. Engel, Soundview Research Associates;</p><p>Norwalk, CT; Mindy J. Sotsky, Soundview Research Associates, Norwalk, CT; James </p><p>Mecham Ferguson, Radiant Research; Salt Lake City, UT; Fares J. Arguello, Radiant </p><p>Research, Salt Lake City, UT; Harold J. Fields, Village Family Practice Clinic, Houston, </p><p>TX; Chester L. Fisher, Jr., Health Research of Hampton Roads; Newport News, VA; </p><p>15 Alan Duane Forker, Saint Luke's Hospital, Lipid and Diabetes Research Center, Kansas </p><p>City, MO; Neil J. Fraser, Troy Internal Medicine Research; Troy, MI; Ken Fujioka, </p><p>Scripps Clinic and Research Foundation; San Diego, CA; Geoffrey S. Gladstein, </p><p>Stamford Therapeutics Consortium, Stamford, CT; David M. Radin, Stamford </p><p>Therapeutics Consortium; Stamford, CT; Forrest Anthony Hanke, Trover Clinic, </p><p>Madisonville, KY; Lisa M Harris, Chase Wellness Center; Virginia Beach, VA; David R.</p><p>Hassman, Comprehensive Clinical Research, Berlin, NJ; David Keith Helton, </p><p>Southeastern Clinical Research, Chattanooga, TN; Priscilla L. Hollander, Baylor </p><p>University Medical Center, Baylor Endocrine Center, Dallas, TX; William P. Jennings, </p><p>Radiant Research, San Antonio, TX; Norman J. Kakos, QUEST Research Institute, </p><p>Bingham Farms, MI; Adam D. Karns, Lovelace Scientific Resources, Inc., Beverly Hills, </p><p>CA; Alan J. Kivitz, Altoona Center for Clinical Research, Duncansville, PA; Eric J. </p><p>Klein, Capital Clinical Research Center, Olympia, WA; Samuel Klein, Washington </p><p>University School of Medicine, Center for Human Nutrition, Saint Louis, MO; Dominic </p><p>Reeds, Washington University School of Medicine, Center for Human Nutrition, Saint </p><p>Louis, MO; Diane Rachel Krieger, Miami Research Associates, Inc., Miami, FL; Wayne </p><p>E. Larson, Radiant Research, Lakewood, WA; Frank P. Maggiacomo, New England </p><p>Center for Clinical Research, Cranston, RI; Dennis C. McCluskey, Radiant Research, </p><p>Mogadore, OH; Harris Hugh McIlwain, Tampa Medical Group, Tampa, FL; James </p><p>McKenney, National Clinical Research, Inc., Richmond, VA; Alan Brad Miller, Atlanta </p><p>Pharmaceutical Research Center, Inc., Dunwoody, GA; Richard E. Mills, Palmetto </p><p>Medical Research, Mount Pleasant, SC; Leslie Penny Moldauer, Radiant Research, </p><p>Denver, CO; Arthur J. Mollen, Mollen Clinic, Phoenix, AZ; David J. Morin, Tri-Cities </p><p>16 Medical Research, Bristol, TN; Bryan C. Pogue, Radiant Research, Boise, ID; Terry L. </p><p>Poling, Heartland Research Associates, LLC, Wichita, KS; Jane L. Rohlf, Premier </p><p>Research, Trenton, NJ; Domenica Marie Rubino, Weight Management Program, </p><p>Washington DC; Richard D. Wasnich, Covance, Inc., Honolulu, HI; Jon Leslie Ruckle, </p><p>Covance, Inc., Honolulu, HI; Gary E. Ruoff, Westside Family Medical Center, </p><p>Kalamazoo, MI; Randall J. Severance, Radiant Research, Chandler, AZ; Stephan C. </p><p>Sharp, Clinical Research Associates, Inc., Nashville, TN; Norman G. Soler, Springfield </p><p>Diabetes and Endocrine Center, Springfield, IL; Joseph Soufer, Chase Medical Research, </p><p>Waterbury, CT; Mark Allen Stich, Jacksonville Center for Clinical Research, </p><p>Jacksonville, FL; Phillip D. Toth, Midwest Institute for Clinical Research, Indianapolis, </p><p>IN; David J. Turk, Madrona Medical Group, Bellingham, WA; Thomas A. Wadden, </p><p>University of Pennsylvania, Weight & Eating Disorder Program, Philadelphia, PA; </p><p>Mervyn Upali Weerasinghe, Rochester Clinical Research, Inc., Rochester, NY; Frederick</p><p>C. Whittier, Clinical Research Limited, Canton, OH; Michael Paul Wiggins, Big </p><p>Thompson Medical Group, PC, Loveland, CO; Troy Williams, Pivotal Research Centers, </p><p>Peoria, AZ; Louise A. Taber, Pivotal Research Centers, Peoria, AZ; James H. Zavoral, </p><p>Radiant Research, Edina, MN; Karl-Michael Derwahl, St. Hedwig-Krankenhaus, Institut fur Klinische Foschung und Entwicklung GmbH, Berlin, Germany; Hans-Michael </p><p>Foerster,Grafschafter Str., Baerl/Ndrhn, Germany; Andreas Hamann, Diabetes Klinik </p><p>Bad Nauheim GmbH, FA fur Innere Medizin, Bad Nauheim, Germany; Alberto </p><p>Allemant, Hospital Nacional "Hipolito Unanue", Lima, Peru; Cesar Butron Delgado, </p><p>Centro Endocrionologico, Arequipa, Peru; Luis H. Zapata-Rincon, Casa De Diabetes Y </p><p>Nutricion, Lima, Peru; Soren Toubro, Hvidovre Hospital, Hvidovre, Denmark; Arya </p><p>17 Sharma, Hamilton Hospital General Division, Hamilton, Ontario, Canada; Paul F. </p><p>Whitsitt, Paradigm Clinical Trials, Inc., Oshawa, Ontario, Canada; Michelle Tolszczuk, </p><p>Q et T Recherche Inc., Sherbrooke, Quebec, Canada; Ronald Girard, Q et T Recherche </p><p>Inc., Sherbrooke, Quebec, Canada; Markolf Hanefeld, Gesellschaft fur Wissens-und </p><p>Technologietransfer der TU Dresden GmbH, Zentrum fur Klinische Studien </p><p>Forschungsbereich Endokrinologie und Stoffwechsel, Dresden, Germany; Peter </p><p>Kindermann, Internistische Praxis, Riesa, Germany; Peter Marcinowski, H.-Arzt </p><p>Torenstr. Meersburg, Germany; Erik-Delf Schulze, Hauptstr. Berlin, Germany; Thomas </p><p>Zoeller, Klinische Forschung Berlin, Berlin, Germany; Francis C.C. Chow, Prince of </p><p>Wales Hospital, Shatin, Hong Kong; Karen Siu Ling Lam, Queen Mary Hospital, Hong </p><p>Kong, Hong Kong; Eduardo Garcia Garcia, Instituto Nacional de Ciencias Medicas y </p><p>Nutricion Salvador Zubiran, Mexico City, Mexico; Jose Geraldo Gonzalez, Hospital </p><p>Universitario de Monterrey, Mexico City, Nuevo Leon, Mexico; Bernhard Paulweber, St.</p><p>Johanns-Spital, Landesklinik fur Innere Medizin I, Salzburg, Austria; Hermann Toplak, </p><p>University of Graz, Medical University Clinic, Ambulanz fur Diabetes und Stoffwechsel, </p><p>Graz, Austria; Christa Firbas, Allgemeines Krankenhaus (AKH) Wien, Klinische </p><p>Pharmakologie, Wien, Austria; Gerfried Hans Karl Nell, ClinPharm International GmbH </p><p>& Co KG, Vienna, Austria; Rudolf Prager, Krankenhaus Lainz, Wein, Austria; Miguel </p><p>Angel Rubio Herrara, Hospital Clinico San Carlos, Madrid, Spain; Xavier Formiguera </p><p>Sala, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain; Olga Gonzalez-</p><p>Albarran, Hospital Ramon y Cajal, Madrid, Spain; Barbara C. Biedermann, Kantonsspital</p><p>Bruderholz, Bruderholz, Switzerland; Bernhard H. Lauterberg, Inselspital, Bern , </p><p>Switzerland; Roger Darioli, CHUV Policlinique Medicale Universitaire, Lausanne, </p><p>18 Switzerland; Alain Golay, Hopitaux Universitaires de Geneve, Division d'Enseignement/Therapeutique pour Maladies Chroniques, Geneva, Switzerland; </p><p>Jocelyne Rachelle Benatar, Green Lane Hospital, Green Lane Clinical Centre </p><p>Cardiovascular Research Unit, Auckland, New Zealand; Ajith Munasinghe Dissanayake, </p><p>Middlemore Hospital, Centre for Clinical Research and Effective Practice, Auckland, </p><p>New Zealand; Siew Pheng Chan, University Malaya Medical Centre, Jalan University, </p><p>Kuala Lumpur, Malaysia; Chii-Min Hwu, Taipei Veterans General Hospital, Taipei, </p><p>Taiwan; Wayne Huey-Herng Sheu, Taichung Veterans General Hospital, Taichung, </p><p>Taiwan; Wei-Shiung Yang, National Taiwan University, University Hospital, Taipei, </p><p>Taiwan; Jeff Karrasch, Peninsula Specialist Centre, Kipparing, Queensland, Australia; </p><p>Robert Moses, Clinical Trials and Research Unit, Wollongong, New South Wales, </p><p>Australia; Boyd Strauss, Monash Medical Centre, Body Composition Laboratory, </p><p>Clayton, Victoria, Australia; Joseph Proietto, Austin & Repatriation Medical Centre, </p><p>Heidelberg, Victoria, Australia; Ian Caterson, Royal Prince Alfred Hospital, Metabolish </p><p>& Obesity Research Group, Camperdon, New South Wales, Australia; Milan Kvapil, </p><p>ResTrial Outpatient Office of Diabetology, Prague, Czech Republic; Vojtech Hainer, </p><p>Institute of Endocrinology, Prague, Czech Republic; Pavol Hlubik, University of </p><p>Defence, Faculty of Military Health Sciences, Department of Preventive Medicine, </p><p>Hradec Kralova, Czech Republic; Gerrit H. de Groot, Nederlandse Obesitas Kliniek, </p><p>Hilversum, Netherlands; Elisabeth M. Mathuss-Vliegen, Academisch Medisch Centrum, </p><p>Amsterdam, Netherlands; Manuel Ignacio Moreno, Av. Portugal, Santiago, Chile; Victor </p><p>Saavedra, NovAdilap Servicios Medicos Ltda, Santiago, Chile; Verner Codoceo, FACH </p><p>Hospital, Tratamiento Intermedio Medico (TIM), Santiago, Chile; Aila Marjatta </p><p>19 Rissanen, Lihavuustutkimusyksikko, Helsinki, Finland; Markku Savolainen, Oulun </p><p>Yliopisto, Sairaala Sisatautien Kilinkka, Oulu, Finland; Manuel Borrell Munoz, Centres d'Assistencia Primeria Sarria, Barcelona, Spain; Albert Ledesma-Castelltort, CAP Remei,</p><p>Barcelona, Spain; Serena Tonstad, Ullevaal Hospital, Ulleval universitetssykehus HF, </p><p>Oslo, Norway; Hans Olav Hoivik, Hedmark Medisinske Senter AS, Hamar, Norway; </p><p>Bard Eirik Kulseng, Sankt Olavs Hospital, Trondheim, Norway.</p><p>20</p>