Curriculum Vitae. Elizabeth Donaghey MSN, ANP, CLNC

Transcription

1 Curriculum Vitae Elizabeth Donaghey MSN, ANP, CLNC PRESENT POSITIONS: Genesis Clinical Research and Consulting, LLC President, CEO and Clinical Director Donaghey & Associates, LLC Legal Nurse Consulting Genesis Health Services WORK TELEPHONE: Genesis Clinical Research, LLC Donaghey & Associates, LLC STATE LICENSURE: Massachusetts Rhode Island CLNC certified EDUCATION: School Date Graduated Degree Somerset High School 1975 College Prep Somerset, MA University of Massachusetts 1979 BSN North Dartmouth, MA Simmons College 1997 MSN/ANP Boston, MA Vicki Milazzo Institute 2010 CLNC BOARD CERTIFICATIONS: ANCC certified Adult Nurse 1997-present # Practitioner NACLNC certified member 6/2010-present

2 PROFESSIONAL EXPERIENCE: 06/10 - Present Donaghey & Associates, LLC Certified Legal Nurse Consultant 373 New Boston Rd Fall River, MA /09 06/10 Nurse Practitioner/Urgent Care Westport Family Medicine Center 827 Main Road Westport, MA /09 Present Genesis Clinical Research/Pharmaceutical Trials Owner, President and Clinical Director Fall River, Ma /04 12/09 Infinity Medical Research/Pharmaceutical Trials Owner, Vice President and Director of Operations N. Dartmouth, MA /02-12/03 JM Clinical Trials/Pharmaceutical Trials SubInvestigator and Consultant 06/02 06/07 New Bedford Medical Associates Adult Nurse Practitioner/Pulmonary Medicine, Adult Medicine/Geriatrics Long Term Care North Dartmouth, MA and Swansea, MA 12/00 02/02 Truesdale Cardiology, Inc Adult Nurse Practitioner/Cardiology Fall River, MA 8/98 07/00 University Medical Group Adult Nurse Practitioner/Cardiology 50 Maude St. Providence, RI Salve Regina University Adjunct Faculty Nursing Dept. Newport, RI and Rhode Island Hospital Rhode Island Hospital Division of Cardiology Clinical Research Coordinator, Providence, RI Rhode Island Hospital, Staff Nurse Intermediate Coronary Care Unit

3 Staff Builders, Staff Nurse, per diem Mystic, CT/ Long Term Care, Geriatrics State University of NewYork, Staff Nurse/Med-Surg Stony Brook Hospital, Stony Brook, NY Morton Hospital, Staff Nurse Medical/Surgical, Cardiology Taunton, MA Boston University Medical Center, Staff Nurse Medical/Surgical Nursing Boston, MA PRESENTATIONS AND PUBLICATIONS: 1. Donaghey EB: Alzheimer s Disease: The latest research and treatment. Presented at Simmons College 11/ Donaghey EB, Terry PA: Dependent Care, Caregiver Burden and Self Care Agency Experiences of the Care Partner in the Cooperative Care Setting at Rhode Island Hospital. Masters Thesis: Presented at Simmons College Annual Research Forum 6/ Donaghey EB: Endocrinopathies in the Elder: When the Diagnosis is Missed. Manuscript: 12/ Donaghey EB, Leaf, ML: Utilization of Primary Care Services by the Homeless Residents at the Pine Street Inn: A Needs Assessment. Presented at Simmons College 6/97. CLINICAL RESEARCH EXPERIENCE: 1. A phase III, open label, outpatient extensions study to assess the long-term safety of XXX in adult primary insomnia patients with sleep maintenance difficulties. Sub-investigator 2. A randomized, double-blind, multi center study to evaluate the tolerability and effectiveness of XXX 90 mg qd vs XXX 50 mg tid in patients with osteoarthritis. Sub-investigator 3. A four-arm study comparing the analgesic efficacy and safety of XXX and doses of 100 mg, 200 mg, 300 mg and placebo for the treatment of pain due to osteoarthritis of the knee. Sub-investigator 4. A randomized, double-blind, placebo-controlled, parallel group, fixed dose, multi center study of weight reducing effect and safety of XXX in obese patients with type two diabetes. Sub-investigator

4 5. Beta Energy Restenosis Trial. A Phase II, randomized, multicenter study to investigate the effect of beta radiation on the restenosis rate of patients post coronary intervention. Clinical Research Coordinator 6. Dynamic Registry of Percutaneous Coronary Intervention. Clinical Research Coordinator. 7. Evaluation of the XXX Stent for Restenosis in Native Arteries. CRC 8. XXX Intracoronary Stent Versus XXX Stent for Elective Use In Denovo Lesions in Native Coronary Arteries. CRC 9. Evaluation of XXX on Restenosis Rates Post Percutaneous Transluminal Coronary Angioplasty in Denovo Lesions. CRC 10. Intraluminal vs Intramural Local Heparin Delivery with The XXX Catheter Prior to Stent Implantation. CRC 11. A double-blind, multicenter study to evaluate the safety and efficacy of aspirin vs coumadin post stent. CRC 12. An evaluation of Rotational Atherectomy post PTCA. CRC 13. A randomized, double blind trial evaluating the Vein Graft Angio-Jet System in patients with total coronary occlusions of thrombus. CRC 14. A Phase II, double blind placebo controlled study to assess the effect of intracoronary and multiple intravenous administration of XXX on exercise tolerance in adults with viable but underperfused myocardium. CRC 15. Effect of XXX on Exacerbation Rate in Patients with Chronic Obstructive Pulmonary Disease. A 52- Week, Multicenter, Double-Blind Study with 500 mg. XXX Once Daily Versus Placebo-(ALTANA Pharma AG) (2004) (Phase 3) 16. A Randomized, Double-Blind Placebo-Controlled, Flexible Dose Study Of The Efficacy and Safety of XXX in Comparison To XXX in Patients With Postherpetic Neuralgia. (Forest Research Institute) (2004) (Phase 2) 17. An Epidemiologic Study of XXX: Evaluating Clinical Effectivness And Long-Term Safety in Patients with Moderate to Severe Asthma (Genetech, Inc) (2004) (Phase 4) 18. A Phase 3, Randomized, Three-Arm, Double-blind, Active Controlled, Parallel Group, Multicenter Trial to Evaluate the Safety and Efficacy of XXX in Combination with XXX Compared to XXX in Combination with XXX in

5 Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on XXX Therapy Alone (Bristol-Myers Squibb Company) (2004) (Phase 3) 19. A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Study of the Safety and Efficacy of XXX Compared to Placebo in the Treatment of Patients with Type 2 Diabetes Mellitus (Takeda Pharmaceuticals) (2004) (Phase 3) 20. A Phase III Pivotal, Multi-center, Double-Blind, Randomized, Placebo- Controlled Mono-therapy Study of XXX for Treatment of Fibromyalgia (Forest Research Institute) (2004) (Phase 3) 21. A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare Clinical Health Outcomes of XXX versus XXX in Outpatients with Community-Acquired Lower Respiratory Tract Infections (Aventis,Inc.) (2004) (Phase IV). 22. Pharmacogenomic Sample Collection from Subjects with Type 2 Diabetes Treated with XXX or XXX (Perlegen Science, Inc.) (2005) 23. A Randomized, Double-blind, Placebo-controlled, Study to Assess Changes in Physical Function in Elderly Patients with Anemia of Chronic Disease (ACD) Receiving XXX (Ortho-Biotech) (Phase 2) (2005) 24. A Randomized, Double-blind, Placebo-controlled, Study to Assess Changes In Physical Function in Elderly Patients with Idiopathic Anemia (IAA) Receiving XXX (Ortho-Biotech) (Phase 2) (2005) 25. A Randomized, Double- blind, Active-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of XXX (BMS ) Compared to XXX In Subjects with Type 2 Diabetes who Have Inadequate Glycemic Control (Bristol-Myers Squibb) (Phase 3) (2005) 26. An Extension Study/ A Pivotal, Multicenter, Double-Blind, Randomized, Placebo-Controlled Monotherapy Study of XXX for Treatment of Fibromyalgia (Forest Research Laboratories) (Phase III) (2005) 26. A Two-Arm Study Comparing the Analgesic Efficacy and Safety of XXX Once-a-Day vs Placebo for the Treatment of Pain Due to Osteoarthritis (Labopharm) (Phase III) (2005) 27. Double-Blind, Multi-Center, Randomized, Parallel-Group, 16 Week Study of 400 or 1600 mg/day XX Administered Orally Once-A-Day with or without a Low Calorie Diet Lead-in in Obese Males and Females (Shionogi USA, Inc) (Phase III) (2005)

6 28. A Multicenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous XXX with Placebo in Patients with Acute Asthma (MERCK) (Phase III) (2005) 30. A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial of XXX Twice Daily in Patients with Fibromyalgia (Pfizer) (Phase III) (2005) 31. A 12-Week, Open-Label Safety Trial of XXX in Patients with Fibromyalgia. (Pfizer) (Phase III) (2005) 32. Effect of XXX on Exacerbation Rate in Patients with Chronic Obstructive Pulmonary Disease- A 52-Week, Double-blind Study with 500 mcg XXX Once Daily versus Placebo (ALTANA) (Phase III) (2006) 33. A Multicenter, Randomized, Double-Blind, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of XXX Versus XXX in patients with Mixed Hyperlipidemia. (MERCK) (Phase III) (2006) 34. A randomized, double-blind, double-dummy, placebo-controlled, 4x4 factorial design trial to evaluate XXX 20, 40 and 80 mg tablets in combination with XXX 2.5, 5 and 10 mg capsules after eight weeks of treatment in patients with Stage I or II hypertension, with an ABP sub-study (Boeringer Ingelheim) (Phase III) (2006) 35. Open-Label Extension of Initial 16-Week Proof-of-Concept Study to Continue Administration of XXX Orally Once-A-Day for 6 Additional Months (i.e., 28- weeks) in Obese Males and Females (Shionogi) (Phase 2) (2006) 36. A Randomized, double-blind, parallel-group, placebo-controlled, multicenter study evaluating the efficacy and safety of three doses of XXX in abdominally obese patients with atherogenic dyslipidemia (sanofi-aventis) (Phase 3) (2006) 37. A Phase IIIb Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of XXX in Subjects with Moderate to Severe Persistent Asthma Who are Inadequately Controlled with High-Dose Inhaled Corticosteroids and Long-Acting Beta-Agonists (Genetech) (Phase 3) (2006) 38. A Multicenter, Randomized, Double-blind, Placebo-Controlled Parallel Group 8- Week Study to Evaluate the Efficacy and Safety of XXX When Initiated at the Start of the School year in Pediatric Patients With Chronic Asthma (Merck) (Phase 3) (2006) 39. A Phase III, Multi-center, Open-Label, Extension Study of XXX for the Treatment of Fibromyalgia (Forest Research Laboratories) (Phase 3) (2006) 40. A randomized, double-blind, double-dummy, placebo-controlled, 3x4 factorial design trial to evaluate XXX 20 and 80 mg tablets in combination with XXX 1.25, 10, and

7 20 mg capsules after eight weeks of treatment in patients with stage I or II hypertension, with an ABPM sub-study (Boehringer Ingelheim) (Phase 3) (2006) 41. Multicenter, Randomized, Double-Blind Study, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of XXX (dosed as coadministered XXX and XXX Tablet) Versus XXX in Patients with Mixed Hyperlipidemia (MERCK) (Phase 3) (2006) 42. A 2-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of XXX in the Treatment of Obese Subjects (Pfizer) (Phase 3) (2006) 43. Lipid Treatment Assessment Project (Pfizer) (Phase: Observational Survey) (2006) 44. Prospective Observational Study to Evaluate Physical Performance and Quality of Life in Older Long Stay Nursing Home Residents with Chronic Kidney Disease with and without Anemia (Omnicare) (Phase 3) (2006) 45. Efficacy and Safety of Inhaled Human Insulin (EXUBERA) Compared With Subcutaneous Human Insulin in the Therapy of Adult Subjects with Type 1 or Type 2 Diabetes Mellitus and Chronic Obstructive Pulmonary Disease: A One-Year, Multicenter, Randomized, Outpatient, Open-Label, Parallel-Group Comparative Trial (Pfizer) (Phase 3) (2007) 46. A Multicenter, Double-Blind Study to Determine the Efficacy and Safety of XXX plus XXX Alone or XXX Alone in Subjects with Type 2 Diabetes (Takeda Pharmaceuticals) (Phase 3) (2007) 47. A Long-Term, Open-Label Extension Study to Investigate the Long-Term Safety of XXX in Subjects with Type 2 Diabetes. (Takeda Pharmaceuticals) (Phase 3) (2007) 48. A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with XXX in Subjects with Active Ulcerative Colitis (UC) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy. (Bristol-Myers Squibb) (Phase 3) (2007) 49. A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate The Clinical Efficacy and Safety of Induction and Maintenance Therapy with XXX in Subjects with Active Crohn s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy. (Bristol-Myers Squibb)(Phase 3) (2007) 50. Double Blind, Multi-Center, Randomized, Parallel-Group, Yearlong Study to Assess the Efficacy and Safety of 0 or 1600 mg/day of XXX Administered Orally Once Daily with an Initial 6-Week Low Calorie Diet In Obese Males and Females (Shionogi) (Phase 3) (2007)

8 51. XXX Add- on Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of XXX in Patients with Postherpetic Neuralgia (PHN) Concomitantly Treated with XXX. (Pfizer) (Phase 2) (2007) 52. A Phase III Pivotal, Multi-center, Double-blind, Randomized, Placebo-Controlled Monotherapy Study of XXX for the treatment of Fibromyalgia (Forest Laboratories) (Phase 3) (2007) 53. A randomized, double-blind, double-dummy, placebo-controlled, 3x4 factorial design trial to evaluate XXX 20 and 80 mg tablets in combination with XXX 1.25, 10, and 20 mg capsules after eight weeks of treatment in patients with stage I or II hypertension, with an ABPM sub-study (Boehringer Ingelheim) (Phase 3) (2006) 54. Multicenter, Randomized, Double-Blind Study, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of XXX (dosed as coadministered XXX and XXX Tablet) Versus XXX in Patients with Mixed Hyperlipidemia (MERCK) (Phase 3) (2006) 55. A 2-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of XXX in the Treatment of Obese Subjects (Pfizer) (Phase 3) (2006) 56. Lipid Treatment Assessment Project (Pfizer) (Phase: Observational Survey) (2006) 57. Prospective Observational Study to Evaluate Physical Performance and Quality of Life in Older Long Stay Nursing Home Residents with Chronic Kidney Disease with and without Anemia (Omnicare) (Phase 3) (2006) 58. Efficacy and Safety of Inhaled Human Insulin (EXUBERA) Compared With Subcutaneous Human Insulin in the Therapy of Adult Subjects With Type 1 or Type 2 Diabetes Mellitus and Chronic Obstructive Pulmonary Disease: A One-Year, Multicenter, Randomized, Outpatient, Open-Label, Parallel-Group Comparative Trial (Pfizer) (Phase 3) (2007) 59. A Multicenter, Double-Blind Study to Determine the Efficacy and Safety of XXX plus XXX Alone or XXX Alone in Subjects with Type 2 Diabetes (Takeda Pharmaceuticals) (Phase 3) (2007) 60. A Long-Term, Open-Label Extension Study to Investigate the Long-Term Safety of XXX in Subjects with Type 2 Diabetes. (Takeda Pharmaceuticals) (Phase 3) (2007)

9 61. A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of XXX Administered Once Daily In Patients with Fibromyalgia. (Pfizer) (Phase 3) (2007) 62. A Randomized, Double-Blind, Parallel-Group, Multi-Center, Multinational Study to Assess Glycemic Control with Rimonabant In Comparison with Glimepiride over 1 Year in Overweight/Obese Type 2 Diabetic Patients Not Adequately Controlled with Metformin. (Sanofi Aventis) (Phase 3) (2007) 63. Double Blind, Multi-Center, Randomized, Parallel-Group, Yearlong Study to Assess the Efficacy and Safety of 0 or 1600 mg/day of XXX Administered Orally Once Daily with an Initial 6-Week Low Calorie Diet In Obese Males and Females (Shionogi) (Phase 3) (2007) 64. XXX Add- on Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of XXX in Patients with Postherpetic Neuralgia (PHN) Concomitantly Treated with XXX. (Pfizer) (Phase 2) (2007) 65. A Phase III Pivotal, Multi-center, Double-blind, Randomized, Placebo- Controlled Monotherapy Study of XXX for the treatment of Fibromyalgia (Forest Laboratories) (Phase 3) (2007) 66. A Study of the Therapeutic Equivalency of XXXmcg and 200 mcg Inhalers in Corticosteroid-Dependent Subjects with Moderate Asthma. (Schering-Plough) (2007) 67. A Randomized Double-Blind-Dummy, Placebo-Controlled, Parallel- Group, Multicenter, Dose Ranging Study to Evaluate the Efficacy and Safety of XXX Inhalation Powder Administered Once Daily and XXX Inhalation Powder Twice Daily Compared with Placebo for 8 Weeks in Adolescent and Adult Subjects With Persistent Asthma Symptomatic on Non-Steroidal, Asthma Therapy. (GlaxoSmith Kline) (Phase 2b) (2007) 68. A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of XXX Inhalation Powder Once Daily and Fluticasone Proionate Inhalation Powder 250 mcg Twice Daily Compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persistent Asthma Symptomatic on Low-Dose ICS Therapy. (GlaxoSmith Kline) (Phase 2b) (2007) 69. A Multicenter, Randomized, Double-Blind, Parallel, Acetylsalicylic Acid (ASA) Run-In Study to Evaluate the EFFECTS of Acetylsalicylic Acid

10 on Niaspan-Induced Flushing in Subjects with Dyslipidemia. (Abbott) (Phase 3) (2007) 70. A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Proof of Concept Study of the Analgesic Effects of XXX in Adult Patients with Post-Herpetic Neuralgia. (Pfizer) (2007) 71. A Randomized Event and Safety Open-Label NSAID Study (GI Reasons) A Randomized, Open-Label, Blinded-Endpoint, Parallel-Group Trial Of GI Safety of XXX Compared with Non-Selective Nonsteroidal Anti-Inflammatory Drugs (NSAIDS) in Osteoarthritis Patients. (Pfizer) (Phase 4) (2007) 72. A Twelve Week, Randomized, Double-Blind, Double-Dummy, Placebo- Controlled, Parallel-Group, Multicenter Trial to Evaluate the Efficacy And Safety of XXX in Comparison to XXX in Patients with Overactive Bladder. (Pfizer) (Phase 3b/4) (2007) 73. A Randomized, Double-Blind Placebo Controlled Trial of [S,S]- Reboxetine in Patients with Chronic Painful Diabetic Peripheral Neuropathy. (Pfizer) (Phase 2b) (2007) 74. A Randomized Double-Blind, Placebo- and Active Control, Parallel-arm, Phase 3 Trial with Controlled Adjustment of Dose To Evaluate the Efficacy and safety of XXX Extended-Release (ER) in Subjects with Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee. (Johnson &Johnson) (2007) 75. Open-Label Extension, single-arm, Flexible-Dosing, Phase 3 Trial with XXX in Subjects with Moderate to Severe Chronic Pain. (Johnson & Johnson) (2007) 76. A Double Blind, Randomized, Placebo-Controlled Study to evaluate the Efficacy and Safety of XXX When Co-Administered with Amlodipine in Subjects with Essential Hypertension. (Takeda) (2007) 77. A Randomized Double-Blind, Placebo-Controlled, Parallel Group, 6-week Clinical Study to Assess the Effect of XXX on Exercise Endurance and Lung Hyperinflation in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease. (Forest Research Institute) (2008) 78. A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Outpatient Trial of XXX in Adults with Nonrestorative Sleep. (Pfizer) (2008)

11 79. An Observational Surveillance Study to Monitor the Occurrence of Rotavirus Acute Gastroenteritis Among a Cohort of Subjects Residing in Several Long Term Care Facilities in the United States. (Merck) (2008) 80. Open-Label Extension (OLE) Safety and Efficacy Study of Velneperit (S-2367) Following the Year-Long Controlled Clinical Trials of S-2367 in Obese Males and Females. (Shionogi) (2008) 81. A Multi- Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Impact on Health-Related Quality of Life of Levocetirizine 5 mg. Once Daily Given for Two Weeks in Subjects 18 years of Age and Older with Seasonal Allergic Rhinitis. (UBC) (2008) 82. A Randomized, Double-Blind, Placebo- and Active- Controlled, Parallel-arm, Multicenter, Study In Subjects With End- Stage Joint Disease to Compare the Frequency Of Constipation Symptoms in Subjects Treated With Tapentadol IR and Oxycodone IR Using a Bowel Function Patient Diary (Johnson & Johnson) (2008) 83. A Multi-Center, Randomized, Open-Label, Controlled Study to Evaluate the Safety, Tolerability, and the Efficacy of Milnacipran When Added to Pregablin in the Treatment of Fibromyalgia. (Forest Research Institute) (2008) 84. General Effect of Liraglutide In Obesity Treatment - Effect of liraglutide on body weight in non-diabetic obese subjects or overweight subjects with comorbidities. - A randomized, double-blind, placebo controlled, parallel group, multi-centre, multinational trial with stratification of subject to either one or three years of treatment based on pre-diabetes status at randomization. (Novo-Nordisk) (2008) 85. A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide when Used in Combination with Metformin in Subjects with Type 2 Diabetes (Takeda) (2009) 86. A Randomized, Double- Blind, Placebo-Controlled, 2 arm, Parallel Group, Multi-Center, Study With a 24- Week Main Treatment Period and an Extension Assessing the Efficacy and Safety of AVE0010 on Top of Piolglitazone in Patients with Type II Diabetes not Adequately Controlled By Pioglitazone. (Sanofi-Aventis 2009) 87. Telmisartan 80 mg plus Amlodipine 10 mg fixed-dose combination tablet Study versus Amlodipine 10 mg over-encapsulated tablets or Telmisartan 80 mg tablets as first line therapy in patients with severe Hypertension: a Phase III, 8 week, randomized, doubleblind, double-dummy, forced titration comparison [TEAMSTA severe HTN] (Boehringer Ingelheim) (2009)

12 88. A Long Term, Randomized, Double-Blind, Extension Study of the Safety and Tolerability and Efficacy of XXX at Two Dose Levels When Administered to Patients with Moderate to severe COPD. 89. Efficacy and Safety of XXX at Three Dose Levels ( 200microgram twice daily, and 400 micrograms twice daily, 200 microgram once daily ) vs Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease ( COPD ). 90. A Randomized, Multicenter, Double-Blind, Placebo-Controlled Discontinuation Study to Evaluate the Durability of Effect of Milnacipran for the treatment of Fibromyalgia in Patients With Long Term Milnacipran Treatment. 91. A Prospective, Randomized Double-Blind Study of the Efficacy of Xolair in Atopic Asthmatics with Good Lung Capacity Who Remain Difficult to Treat. 92. A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study Evaluating the Efficacy and Safety of Tanezumab for the Treatment of Moderate to Severe Pain Associated With Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) (Pfizer) (2009) 93. A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects with Euvolemic Hyponatremia (Cardiokine) (2009) 94. A Long-Term, Randomized, Double-blind Study of the Safety, Tolerability and Efficacy of Aclidinium Bromide at Two Dosage Levels When Administered to Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (Forest) (2009) 95. A Randomized, Double Blind, Parallel-Group Study of Cardiovascular Safety in Osteoarthritis or Rheumatoid Arthritis Patients with or at High Risk for Cardiovascular Disease Comparing Celecoxib with Naproxen and Ibuprofen. (Pfizer) (2010) 96. A Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy, Safety and Tolerability of 2 Doses of Aclidinium Bromide Compared With Placebo for 12 Weeks in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease Followed by a 40-Week Evaluation of the Higher Aclidinium Bromide Dose (Forest) (2009) 97. A Cardiovascular Outcomes Study to Evaluate the Potential of Aleglitizar to Reduce Cardiovascular Risk in Patients With a Recent Acute Coronary Syndrome (ACS) Event and Type 2 Diabetes Mellitus (T2D)