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PACIFIC RESEARCH NETWORK, INC _3003 Fourth Avenue, San Diego, CA 92103 * (619) 294-4302 Ph. (619) 294-4867 Fax

STEPHEN G. THEIN, Ph.D.

EDUCATION1974 Ph.D: Professional Psychology, United States International University1972 MA: Human Behavior, United States International

University1971 BA: California Western University

TRAINING1976 – 1978 Externship: San Diego Neuropsychiatric Medical Clinic1973 - 1976 Internship: Catholic Diocese, University of California San

Diego

MEDICAL EXPERIENCE2014 – Present Consultant, Advisory Board, Clinilabs Scientific Affairs Group (SAG)2003 -- 2011Consultant, Speaker, Alzheimer’s Disease Rater, Trainer, Pharmastar2004 -- 2010Consultant, Sleep Disorders Speakers Bureau, Sepracor Inc.2004 -- 2010Consultant, Alzheimer’s Disease Speakers Bureau, Forest Research Institute1998 Consultant, Alzheimer’s Disease Speakers Bureau, Novartis Pharmaceuticals1993 -- 1996Consultant, Alzheimer’s Disease Speakers Bureau, Warner-Lambert, Parke-Davis1989 -- 1997Consultant and Editorial Advisory Board, CardiSense, Hoechst Marion Roussel, Inc.1987 – 1989 Clinical Trials Consultant, Institute for Biological Research andDevelopment1981 – 1986 Clinical Director, Employee Assistance Program for Occupational

Health Management, Inc.1980 – 1981 Clinical Director, ADAPT (Alcohol Detoxification and Preliminary Treatment) Program1979 – 1986 Director, Principal Investigator, Psychological Services of San Diego1978 -- Present Director, Principal Investigator, Pacific Research Network, San

Diego, California 1975 Health Consultant, San Diego Board of Supervisors1973 – 1978 Production and Distribution of Educational and Therapy Models, Training Films and

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Multi-Media Presentations

CERTIFICATION AND LICENSUREAmerican Academy of Sleep Medicine-MemberClinical Psychologist/California Board of PsychologyNational Register of Health Service ProvidersAmerican Board of Psychological Specialties, Psychopharmacology – DiplomateAmerican College of Advanced Practice Psychologists, Founding Fellow, Board CertifiedNational Institutes of Health, Human Participants Protection Education for, Research Teams- Online Course- Completed 4/25/01American Society of Clinical Psychopharmacology- Member

Licensure: State of CaliforniaLicense Number: PSY 5218Expiration Date: August 31, 2014

PROFESSIONAL ORGANIZATIONS:American Academy of Sleep Medicine-MemberAmerican College of Forensic ExaminersAlzheimer’s Association- San Diego Chapter- Medical and Scientific Advisory BoardAmerican Psychological Association, Division 55: Clinical PsychopharmacologyBiomedical Research Institute of America, Retired Fellow, Board of Directors, PastPresidentNational Register – Health Service Providers, Psychology, PsychopharmacologySan Diego Science and Engineering Fair, Board of Governors, Judging Committee,AdvisorSouthern Caregiver Resource Center, Retired Fellow, Board of Directors, Past PresidentPrescribing Psychologists’ RegisterAmateur Radio Relay League and Emergency ServiceAmateur Radio Operator, Extra Class

PAPERS, JOURNAL PUBLICATIONS, AND PARTICIPATORY RECOGNITION1. Thein, S.G., et al. “Galantamine in AD - A 6-Month Randomized,

Placebo-Controlled Trial with a 6-Month Extension”, American Academy of Neurology, June 2, 2000.

2. Thein, S.G., et al. “Reminyl Significantly Benefits the Cognitive, Functional, and behavioral Symptoms of AD”, Clinical Consultants Update, Newsletter. As Presented at 52nd AAN Meeting, April 29 – May 6, 2000, SanDiego, California.

3. Thein, S.G., et al. “Reminyl Produces Cognitive and Functional Benefits for 12 Months or More in Patients with AD”, Clinical Consultants Update,

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Newsletter. As Presented at 52nd AAN Meeting, April 29 – May 6, 2000, SanDiego, California

4. Thein, S.G., et al. Drug: Galantamine: U.S. Phase III Results from New Alzheimer’s Drug Suggest Potential Novel Mode of Action, International Conference on Alzheimer’s Disease and Related Disorders (ICADRD), Amsterdam, The Netherlands, July 1999.

5. Adelglass, J.M., Brownstone, P., Thein, S.G., et al. Efficacy and Tolerabilityof the Neurogenic Inflammation Inhibitor 4991W93 in the Acute Treatmentof Migraine, Poster Form, Displayed at 9th Congress of the International Headache Society, Spain, June 1999.

6. Katz, I., Jeste, D., Thein, S.G., et al. Comparison of Risperidone and Placebo for Psychosis and Behavioral Disturbances Associated With Dementia: A Randomized, Double-Blind Trial , Journal of Clinical Psychiatry, February 1999.

7. Fry, J., Thein, S.G. et al. A Phase III, 28 Day, Multicenter, Randomized, Double-Blind Comparator-and Placebo-Controlled, Parallel-Group Safety, Tolerablitity and Efficacy Study of 5, 10, and 20 mg of Zaleplon, Comparedwith 10 mg of Zolpidem or Placebo in Adult Outpatients with Insomnia, Sleep, 1998; 21(suppl):262.

8. Fry, J., Thein, S.G., et al. Modafinil for the Treatment of Pathological Somnolence in Narcolepsy, Annuals of Neurology, January 1998.

9. Fry, J., Scharf, M.B., Thein, S.G., et al. Phase III, 28 Day , Multicenter, Randomized, Double-Blind Comparator – and Placebo-Controlled, Parallel-Group Safety, Tolerability and Efficacy Study of 5, 10, and 20 mg. of Zaleplon, Compared with 10 mg. of Zolpidem or Placebo, in Adult Outpatients With Insomnia, Submitted to the APSS Meeting, 1998.

10. Thein, S.G., et al. Evaluation of Efficacy and Safety Data with Long-Term Use of Modafinil in Patients with Narcolepsy, Presented by Sahota, P. at theANA in San Diego California, 1997.

11. Thein, S.G., et al. Risperidone in the Treatment of Psychosis and Aggressive Behavior in Patients with Dementia, Presented by: Katz, I., Brecher, M., Clyde, C. and the Risperidone Study Group at the ACNP meeting, 1997.

12. Mathew, N., Klaussen, A., Thein, S.G., et al. Naratriptan Tablets Are Effective and Well-Tolerated in the Acute Treatment of Migraine; Results ofa Double-Blind, Placebo Controlled, Parallel-Group Trial, 49th Annual Meeting of the American Academy of Neurology, Boston, Massachusetts 1997.

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13. Thein, S.G., et al. Efficacy and Tolerability of Naratriptan Tablets in the Treatment of Migraine: Results of a Double-Blind, Placebo-Controlled, Crossover Trial, Presented by: Peykaian, M., Laurenza, A. at the 49th Annual Meeting of the American Academy of Neurology, Boston, Massacusetts, 1997.

14. Thein, S.G., et al. A Double-Blind Comparison of Nefazodone and Sertaline in Highly Anxious Patients with Major Depression, Presented by: Feighner, J.P. at the New Clinical Drug Evaluation Unit Program Meeting, 1996.

15. Cohn, C.K., Thein, S.G., et al. A Double-Blind Comparison of Nefazodone and Sertraline in Highly Anxious Patients with Major Depression, American Psychiatric Association Annual Meeting, New York, New York 1996.

16. Knopman, D., Thein, S.G., et al. Long-Term Tacrine (Cognex) Treatment: Effects on Nursing Home Placement and Mortality, Neurology, Vol. 47, July 1996.

17. Ryan, R., Jr., Thein, S.G., et al. Twenty-Four Hour Effectiveness of BMS-180048 in the Acute Treatment of Migraine, European Headache Foundation Annual Meeting, Sardinia, Italy 1996.

18. Crusey, J.E., and Thein, S.G., Sexual Issues and Alzheimer’s Disease, Caring, Vol. 1, Number 9, August 1995.

19. Feldmann, T., Tilker, H.A., and Thein, S.G., Psychopharmacology, in R. Meyer’s The Clinician’s Handbook, 4th Edition, Allyn & Bacon, Boston 1995.(In Press)

20. Knapp, M., Pharm. D., Thein, S.G., et al. A 30-Week Randomized Controlled Trial of High Dose Tacrine in Patients with Alzheimer’s Disease, Journal of the American Medical Association, Vol 271, No. 13, pp. 985-991, April 1994.

21. Thein, S.G., and Tilker, H.A., The Alzheimer’s Disease Assessment Scale (ADAS): A Training Video, Somerville: Hoechst-Roussel Pharmaceuticals, Inc., 1993.

22. Thein, S.G., and Tilker, H.A., The Alzheimer’s Disease Assessment Scale (ADAS): Administration Manual and Scoring Criteria, Somerville: Hoechst-Roussel Pharmaceuticals, Inc., 1993.

23. Thein, S.G., Memory Loss, A Normal Part of Aging?, Seniors Only, August,1992.

24. Thein, S.G., Depression – The “Common Cold” of Our Emotions, Seniors Only, September 1992.

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25. Thein, S.G., A Hidden Hazard – Carbon Monoxide and the RV, CardiSense,Marion Merrell Dow, Inc., Vol. II, Number 1, 1992.

26. Thein, S.G., Research Medicine: The Future is Now, Seniors Only, October1992.

27. Farlow, M., M.D., et al, A Controlled Trial of Tacrine in Alzheimer’s Disease, Journal of the American Medical Association, Vol. 268, No. 18: pp. 2523-2529, November 1992.

28. Preventing Carbon Monoxide Poisoning in Your RV or Other Vehicle, Arizona Mobile Citizen, January, 1989.

29. Carbon Monoxide and Your Health, Motorhome Magazine, Trailer Life Enterprises, 1989.

30. Proceedings of the International Workshop, Anxious Depression Assessment and Treatment, Milan, Italy, September 22-23, 1986. Aden, G.C., Treatment of Anxious Depression: Current Models of Evaluation, PartII, Adinazolam – an Antidepressant Under Investigation, 1986.

31. Pyke, R.E., et al. Thein, S.G.,., Contributory Investigator; The Effects of Adinazolam, Imipramine and Placebo in Depressed Outpatients, An Unpublished Paper, 1986.

32. Feigner, J.P., A Review of Control Studies of Adinazolam Mesylate in Patients with Major Depressive Disorder, Psychopharmacology Bulletin, Vol. 22, pp. 186-192, 1986

33. Aden, G.C., Thein, S.G.,., et al. Alprazolam Compared Diazepam and Placebo in the Treatment of Anxiety, Journal of Clinical Psychiatry, 41:22-24, January 1983.

34. Alprazolam in Clinically Anxious Patients with Depressed Mood, Journal of Clinical Pharmacology, 44:22-24, January 1983.

35. Comparison of Alprazolam, Imipramine, and Placebo in the Treatment of Depression, Journal of the American Medical Association, 249:3057-3064, June 1983.

36. Freedom is a Satiated Pigeon – Concepts and Treatment Techniques, PaperPresented to International Conference, A.P.A. Montreal, Canada, 1974.

37. Thein, S.G., Success Factors of Methadone Maintenance, Unpublished Doctoral Dissertation, 1974.

38. Treatment of Phobics – A Systematic Desensitization Technique Explained,Paper and Film Presented to A.P.A., Santa Barbara, California, 1973.

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39. Thein, S.G., Graphological Indices of Personality, Unpublished Thesis, 1972.

40. Fry, J., Scharf, M.D., Berkowitz, D.V., et al.: "A Phase III, 28 Day, Multicenter, Randomized, Double-Blind Comparator - and Placebo-Controlled, Parallel-Group Safety, Tolerability, and Efficacy Study of 5, 10, and 20 mg of Zaleplon, Compared with 10 mg of Zolpidem or Placebo, in Adult Outpatients with Insomnia." Sleep. 1998; 21 (suppl): 262., Stephen G. Thein, Ph.D. Contributor.

41. Elaine Fuseau, Olivier Pertricoul, Antony Sabin, Adrian Pereira, Stephen O’Quinn, Stephen Thein, Mark Leibowitz, Helen Purdon, Scott McNeal, Reijo Salonen, Alan Metz, Peter Coates: Effects of Encapsulation on Absorption of Sumatriptan Tablets: Data From Healthy Volunteers and Patients During Migraine. Clinical Therapeutics Volume (issue): 23 (2) 2001, pp 242-251

42. Pierre N. Tariot, Leon Thal, Laura Jakimovich, Ronald Thomas, RemaRaman, and the ADCS Valproate Nursing Home Study Group: “AMulticenter, Randomized, Double-Blind, Placebo-Controlled Trial ofValproate Agitation Associated with Dementia” December 2003 AmericanCollege of Neuropsychopharmacology (ACNP) Poster, Stephen G. Thein,Ph.D., Contributor.

43. Jed Black, Max Hirshkowitz, Craig Q. Earl, for the Modafinil in ObstructiveSleep Apnea Study Group: “Modafinil Adjunctive Therapy ImprovesExcessive Sleepiness and Quality of Life in Obstructive Sleep Apnea: A12-Month Open-Label Extension Study” June 2003 Annual MeetingAssociated Professional Sleep Societies Poster, Stephen G. Thein, Ph.D.,Contributor.

44. K. Rockwood, J. Mintzer, L. Truyen, T. Wessel, D. Wilkinson: “Effects of aFlexible Galantamine Dose in Alzheimer’s Disease: A Randomized,Controlled Trial” Journal of Neurology, Neurosurgery and Psychiatry; 2001;71 pp 589-595, Contributory Investigator.

45. S.A. Reines, MD, G.A. Block, MD, J. C. Morris, MD, G. Liu, Ph.D., M. L.Nessley, MS, C.R. Lines, Ph.D., B.A. Norman, BS and C.C. Baranak, MA onbehalf of the Rofecoxib Protocol 091 Study Group: “Rofecoxib: No effecton Alzheimer’s disease in a 1-year, randomized, blinded, controlledstudy”; American Academy of Neurology; Neurology 2004; 62: pp 66-71,Contributory Investigator.

46. D. Canafax, PharmD, C. Kushida, MD, Ph.D., P. Becker, MD, A. Perkins, MD, Ph.D., S. Thein, Ph.D., A. Walters, MD, and T. Roth, Ph.D., “XP13512 Improves Symptoms and Sleep Disturbance in RLS Patients: Results of a 2-Week, Randomized, Double-Blind, Placebo-Controlled Cross-Over Polysomnography Trial.”; Sleep, Volume 29, Abstract Supplement, 2006;

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20th Anniversary Meeting of the Associated Professional Sleep Societies, June 2006.

47. C. Kushida, A. Walters, P. Becker, S. Thein, Ph.D., A. Perkins, T. Roth, D. Canafax, R. Barrett, “A Randomized, Double-Blind, Placebo-Controlled, Crossover Study of XP13512/GSK1838262 in the Treatment of Patients with Primary Restless Legs Syndrome.” Sleep 2009; 32(2): 159-168.

48. A. Ellenbogen, S. Thein, Ph.D., D. Winslow, P. Becker, J. Tolson, H. Conklin, M. Lassauzet, D. Chen, “An Open-Label, 52-Week Extension Studyto Assess the Long-Term Tolerability and Efficacy of Gabapentin Enacarbil in Subjects with Moderate-to-Severe Primary Restless Legs Syndrome.” American Academy of Neurology, 62nd AAN Annual Meeting April 13, 2010,Presentation and Poster Session II.

49. A. Ellenbogen, S. Thein, Ph.D., D. Winslow, P. Becker, J. Tolson, H. Conklin, M. Lassauzet, D. Chen, “An Open-Label, 52-Week Extension StudyAssessing Tolerability and Efficacy of Gabapentin Enacarbil in Subjects with Primary Restless Legs Syndrome.” American Academy of Neurology, 62nd AAN Annual Meeting April 10, 2010, Presentation.

50. G. Rippon, D. Greve, S. Duntley, L. Larson-Prior, A. Krystal, B. Fischl, S. Thein, Ph.D., R. Yang, J. Dayno, C. Kushida, R. Thomas, “A Multicenter, Randomized, Double-Blind, Placebo-Controlled fMRI Study of the Effect of Armodafinil on Prefrontal Cortical Activation in Patients With Residual Excessive Sleepiness Associated With CPAP-Treated OSA.” American Academy of Neurology, 62nd AAN Annual Meeting April 10, 2010, Poster.

51. G. Rippon, D. Greve, S. Drummond, S. Duntley, L. Larson-Prior, A. Krystal,

M. Diaz, B. Fischl, S. Thein, Ph.D., R. Yang, J. Dayno, C. Kushida, R. Thomas, “Effect of Armodafinil on Cortical Activity and Working Memory inPatients With Residual Excessive Sleepiness Associated With CPAP-TreatedOSA: A Multicenter fMRI Study.” American Thoracic Society, 2010 International Conference, May 14-19, 2010, New Orleans, LA, Presentation.

52. S. Thein, Ph.D., A. Mahableshwarkar“It’s Only a Little Ice: A Personal View with Companion Commentary,” Innovations in Clinical Neuroscience, February 2012.

53. V. Coric, C. Van Dyck, S. Salloway, N. Andreasen, M. Brody, R. Richter, H. Soininen, S. Thein, Ph.D., T. Shiovitz, G. Pilcher, S. Colby, L. Rollin, R. Dockens, C. Pachai, E. Portelius, U. Andreasson, K. Blennow, H. Soares, C. Albright, H. Feldman, R. Berman, “Safety and Tolerability of the Gamma Secretase Inhibitor Avagacestat in a Phase 2 Study in Mild-to-Moderate Alzheimer’s Disease.” Archives of Neurology, May 2012.

54. D. Greve, S. Duntley, L. Prior, A. Krystal, M. Diaz, S. Drummond, S. Thein, Ph.D., C. Kushida, R. Yang, R. Thomas, “Effect of Armodafinil on Cortical

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Activity and Working Memory in Patients with Residual Excessive Sleepiness Associated with CPAP-Treated OSA: A Multicenter fMRI Study.” Journal of Clinical Sleep Medicine, October 2013.

55. A. Istace, L. Bracoud, R. Berman, F. Luo, F. Roche, S. Salloway, C. Van Dyck,B. Dubois, N. Andreasen, M. Brody, C. Curtis, H, Soininen, S. Thein, Ph.D., T. Shiovitz, S. Ferris, J. Grill, S. Gouttard, J. Schaerer, W. Hayes, S. Kaplita, B. Belaroussi, H. Yu, J. Cedarbaum, H. Feldman, C. Pachai, V. Coric, “Volumetric MRI Results of BMS Avagacestat in a Prodromal AD Population.” Abstract Submitted to the AAIC Meeting 2014.

CLINICAL RESEARCH EXPERIENCE1. A Multicenter Double-Blind Trial of XXXXXX and Placebo in the Treatment

of Elderly Depressed Outpatients

2. An Open-Label Trial of XXXXXX in the Treatment of Elderly DepressedOutpatients

3. A Double-Blind Multicenter Trial of XXXXXX and Sertraline in the Treatmentof Highly Anxious Outpatients with Major Depression

4. A Double-Blind Multicenter Trial of XXXXXX and Sertraline in theContinuation Treatment of Highly Anxious Outpatients with MajorDepression

5. A Multicenter Double-Blind Trial of XXXXXX, Diazepam, and Placebo in theTreatment of Anxious Outpatients

6. An Open Multicenter Trial of XXXXXX in the Treatment of Patients withAnxiety Disorder

7. A Double-Blind Dose Response Trial of XXXXXX Compared to Placebo inthe Treatment of Acute Migraine Attacks

8. An Open-Label Long-Term Trial Evaluating the Safety of XXXXXX in theTreatment of Patients with Migraine Headache With or Without Aura

9. A Nine-Week Placebo-Controlled, Double-Blind, Randomized,Parallel-Group Study of the Safety and Efficacy of Two Fixed Doses of OralXXXXXX in Patients with Narcolepsy, Followed by a Two-WeekDiscontinuation Segment, Followed by a Forty-Week, Open-Label,Flexible-Fixed Dose Continuation Study

10. A Double-Blind Comparison of XXXXXX with Placebo in the Treatment ofAlcohol Withdrawal in Recently Admitted Alcoholic In-Patients

11. An Open-Label Study of XXXXXX in Patients with Mild to ModerateDementia of the Alzheimer’s Type

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12. Double-Blind Placebo and Diazepam Controlled Study of XXXXXX inAnxious Patients

13. A Randomized, Double-Blind, Placebo-Controlled Study of the Safety andEfficacy of Two Doses of XXXXXX versus Placebo in Treatment of SocialPhobia

14. Double-Blind, Placebo-Controlled, Multiple-Fixed Dose Evaluation ofXXXXXX versus XXXXXX in the Treatment of Generalized Anxiety Disorder

15. A Double-Blind, Placebo-Controlled, Multiple-Fixed Dose of Evaluation ofXXXXXX (GAD)

16. A Randomized Double-Blind, Placebo Controlled, Crossover Protocol toEvaluate the Safety and Efficacy of Suppositories and XXXXXX in theAcute Treatment of Multiple Migraine Attacks

17. A Double-Blind, Placebo-Controlled Study to Determine the Efficacy andSafety of Orally Administered XXXXXX in the Treatment of Secondary(Acquired) Erectile Disorder

18. A Multicenter, Double-Blind, Evaluation of the Efficacy and Safety ofXXXXXX in the Treatment of Patients with Major Depressive Disorder

19. A Double-Blind, Placebo-Controlled, Dose-Escalation Study of the Safetyand Efficacy of Oral XXXXXX in the Treatment of Patients with PanicDisorder

20. A Randomized, Double-Blind, Placebo-Controlled, Crossover Study toEvaluate the Efficacy of Oral XXXXXX in the Acute Treatment of FourMigraine Attacks

21. A Study to Evaluate the Pharmacokinetics and Pharmacodynamics of OralXXXXXX in Migraine Subjects

22. Multi-Center, 35-Week, Double-Blind, Parallel Group Safety, Tolerance andEfficacy Comparison of Placebo and XXXXXX in Outpatients withAlzheimer’s Disease

23. Multi-Center, Double-Blind, Parallel Group, Safety, Tolerance and EfficacyComparison of Placebo and XXXXXX in Outpatients with Alzheimer’sDisease

24. Forty-Eight Week Efficacy and Safety Study of XXXXXX in Patients withAlzheimer’s Disease

25. Twenty-Four Week Efficacy and Safety Study of XXXXXX in Patients withVascular Dementia

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26. A Comparison of the Efficacy and Safety of XXXXXX with Nifedipine GITS inan 8-Week Treatment of Patients with Chronic Stable Angina Pectoris

27. A Placebo-Controlled Study to Determine the Effects of XXXXXX inIschemic Stroke Patients

28. Long Term XXXXXX versus Hydrochlorothiazide Double-Blind Parallel inPatients with Hypertension

29. Clinical Evaluation of the Efficacy and Safety of XXXXXX in the Treatmentof Alzheimer’s Disease

30. A Randomized, Double-Blind, Placebo Controlled Study of XXXXXX forTreatment of Behavioral Disturbances in Subjects with Dementia

31. Safety of XXXXXX in the Long-Term Treatment of Alzheimer’s Disease

32. The Efficacy and Safety of XXXXXX versus Sumatriptan in the AcuteTreatment of Migraine: A Randomized Double-Blind, Placebo-Controlled,Single Dose Trial

33. A Randomized, Double-Blind Placebo Controlled Trial to Evaluate theEfficacy and Safety of XXXXXX Given Subcutaneously in the AcuteTreatment of Migraine

34. Open Evaluation of the Long-Term Efficacy, Safety and Tolerability ofXXXXXX in the Acute Treatment of Migraine Attacks

35. Efficacy, Tolerability and Safety of XXXXXX in the Treatment of Alzheimer’sDisease

36. XXXXXX in the Treatment of Alzheimer’s Disease: Flexible Dose RangeTrial

37. Long-Term Safety and Efficacy of XXXXXX in the Treatment of Alzheimer’sDisease (1138)

38. Long-Term Safety and Efficacy of XXXXXX in the Treatment of Alzheimer’sDisease (2485)

39. Long-Term Safety and Efficacy of XXXXXX in the Treatment of Alzheimer’sDisease

40. Placebo-Controlled Evaluation of XXXXXX in the Treatment of Alzheimer’sDisease: Safety and Efficacy Under a Slow-Titration Regimen

41. Safety and Efficacy of XXXXXX During Withdrawal in the Treatment ofAlzheimer’s Disease: Blinded Withdrawal Trial

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42. A Double-Blind Pilot Study to Evaluate the Safety and Efficacy of XXXXXXTherapeutic Implant XXXXXX as Compared to XXXXXX When Administeredto Patients with External Condylomata Acuminata

43. A Randomized Double-Blind Controlled Study to Evaluate the Contributionof Components in the Therapeutic Implant XXXXXX When Administered toPatients with External Condylomata Acuminata

44. Open-Label Re-Treatment Study Describing and Evaluating the Safety andEfficacy of the XXXXXX in the Treatment of Condylomata Acuminata

45. Phase II Double-Blind Controlled Study of XXXXXX and Placebo to EstablishEfficacy in the Treatment of Outpatients with Depression

46. Safety and Efficacy versus XXXXXX in Outpatients with RecurrentDepression

47. Efficacy and Safety in Outpatients with Major Depression, 5 ½ Month,Phase III Study

48. Efficacy and Safety in Outpatients with Major Depression, 6 Month, PhaseIII Study

49. Long-Term Safety in Patients with Chronic Non-Malignant Pain

50. XXXXXX for the Treatment of Mild Cognitive Impairment and Prevention ofConversion to Alzheimer’s Disease (1160)

51. The Safety and Efficacy of XXXXXX in Slowing the Progression of theSymptoms of Alzheimer’s Disease (2486)

52. A Phase II Study of the Efficacy and Safety of XXXXXX in Patients withPrimary Degenerative Dementia (PDD)

53. An Open-Label Study to Evaluate the Safety and Efficacy of XXXXXXThrough XXXXXX of XXXXXX in Patients with Mild to Severe ProbableAlzheimer’s Disease in the Community Setting (1166)

54. A Randomized, Double-Blind, Dose-Range Finding, Multicenter,Parallel-Group, Active and Placebo-Controlled Trial of the Safety andEfficacy of XXXXXX in Patients with Moderate to Severe Major DepressiveDisorder.

55. A Multicenter, Randomized, Double-Blind, Parallel-Group,Placebo-Controlled, Dose-Range Finding Trial to Evaluate the Safety andEfficacy of Four Doses of XXXXXX in Patients with Social Phobia.

56. A Double-Blind, Placebo Controlled, High Dose Study of XXXXXX in Patientswith Alzheimer’s Disease

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57. An Open-Label, High Dose Study of XXXXXX in Patient’s With Alzheimer’sDisease

58. A Double-Blind, Placebo Controlled Study of XXXXXX with and Open-LabelExtension and Compassionate Use (AD)

59. A 12-Week, Double-Blind, Placebo-Controlled; Parallel-Group,Dose-Response, Multicenter Study of XXXXXX in Patients with Alzheimer’sDisease

60. A 16-Week, Open-Label Safety Study of XXXXXX with Monitoring ofXXXXXX at Weeks 4, 6, 8, 12, and 16 (AD)

61. 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group,Dose Response Multicenter Study of XXXXXX with a 16-Month Open-LabelExtension in Patients with Dementia of the Alzheimer’s Type

62. A 26-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group,Multicenter Study of XXXXXX in Patients with Probable Alzheimer’sDisease

63. A Non-Randomized Open-Label Extension, Multicenter Study of XXXXXX inPatients with Probable Alzheimer’s Disease

64. A Double-Blind, Placebo-Controlled, Parallel 3-Day Treatment and 3-MonthFollow-up, Multicenter Study to Evaluate the Safety and Efficacy ofIntravenous XXXXXX in Patients with Acute Ischemic Stroke

65. Phase II, Randomized, Double-Blind, Placebo-Controlled Study of theSafety and Efficacy of Three Doses of XXXXXX Administered for 12 Weeksto Subjects with Alzheimer’s Disease

66. Phase II, Open-Label, Multicenter Extension Study of the Safety andEfficacy of XXXXXX Administered for Twenty-Six Weeks to Subjects withAlzheimer’s Disease

67. A Six-Week, Double-Blind, Placebo- and Fluoxetine-Controlled MulticenterStudy to Evaluate the Safety and Efficacy of Oral XXXXXX in Outpatientswith Major Depressive Disorder

68. A Double Blind, Placebo-Controlled, Parallel Design Study to Determine theEffects of Orally Administered XXXXXX versus Placebo on Survival I RecentPost-Myocardial Infarction Patients at Risk of Sudden Death

69. A Randomized, Double-Blind, Multicenter Progestin Efficacy Study of ThreeDoses of XXXXXX Patches in Continuous Wear Compared to an Estradil 50Patch

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70. Double-Blind Study of XXXXXX and Placebo (GAD)

71. Randomized, Double-Blind, Placebo-Controlled Multicenter Trial toDemonstrate the Clinical Efficacy and Safety of Two Different Doses ofXXXXXX in Patients Suffering from Dementia of the Alzheimer’s TypeAccording to DSM-IV and NINCDS/ADRDA Criteria (1250)

72. A Dose-Titration, Safety and Efficacy Study of XXXXXX in the Treatment ofErectile Dysfunction in Diabetic and Non-Diabetic Patients Followed by 48Weeks of Open-Label Treatment

73. A Double-Blind, Placebo Controlled, Parallel Group Study to Assess theSafety, Tolerability and Pharmacokinetics Following Repeated-Dose UpTitration of XXXXXX in Patients with Mild to Moderate Dementia of theAlzheimer’s Type

74. An Open-Label Administration Study of XXXXXX In Patients Suffering FromDementia of the Probable Alzheimer’s Type

75. A 48 Week Double-Blind, Placebo Controlled, Parallel Group, Fixed DoseStudy of the Efficacy, Safety and Cost-Effectiveness of XXXXXX in PatientsSuffering from Dementia of the Probable Alzheimer’s Type

76. A Twelve Month, Double-Blind, Placebo-Controlled, Investigation of theSafety and Efficacy of XXXXXX Transdermal System XXXXXX in Patientswith Dementia of the Alzheimer’s Type

77. A Study to Evaluate the Effects of XXXXXX on Acute Duodenal Ulcer

78. A Study to Evaluate the Effects of XXXXXX on Acute Gastric Ulcer

79. A Study to Evaluate the Effects of XXXXXX on Acute GastroesophagealReflux Disease

80. A Randomized, Double-Blind, 12-Month Safety and Efficacy Trial of XXXXXXin Patients with Probable Alzheimer’s Disease

81. A Randomized, Double-Blind, 12-Month Safety and Efficacy Study ofXXXXXX or Placebo Added to Treatment with Donepezil HCI 10 mg qd inPatients with Probable Alzheimer’s Disease

82. A Double-Blind, Placebo-Controlled, Randomized Study of the Safety andEfficacy of a Combination of Insulin and Two Doses of XXXXXX in theTreatment of Patients with Non-Insulin Dependent Diabetes Mellitus(NIDDM)

83. A Double-Blind Randomized Trial Comparing Four Doses of XXXXXX andPlacebo in the Treatment of Outpatients with Migraine Headaches

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84. A Fixed-Dose, Placebo-Controlled, Dose-Response Study of XXXXXX in theTreatment of Mixed Anxiety and Depressive Disorder

85. Comparison of XXXXXX, Valium, and Placebo in the Treatment of Anxiety

86. Comparison of XXXXXX versus Valium versus Placebo (GAD)

87. Comparison of Therapeutic Effect, Tolerance and Safety of XXXXXX andDiazepam Administered Six Months to Outpatients with Chronic AnxietyNeurosis

88. Comparison of XXXXXX, Imipramine, and Placebo in the Treatment ofNeurotic Depression

89. Comparison of Long Term Efficacy and Tolerance of XXXXXX and Diazepamin Outpatients with Chronic Generalized Anxiety Disorder or MinorDepressive Disorder

90. Double-Blind Efficacy and Safety Study Comparing XXXXXX, Imipramineand Placebo in Depressed Outpatients

91. Efficacy Study for XXXXXX in Patients with Exertional Angina Pectoris – BIDDosing

92. Efficacy Study for XXXXXX in Patients with Exertional Angina Pectoris- TIDDosing

93. Collaborative Fixed –Dose Study of the Efficacy and Safety of XXXXXXTablets in Generalized Anxiety Disorder

94. Comparison of XXXXXX and Certriaxone in the Treatment ofUncomplicated Gonococcal Infection

95. Treatment of Gonococcal Infections with Intramuscular XXXXXX orCertriaxone Sodium (Rocephin)

96. XXXXXX Treatment of Insomnia in Depressed Patients Receiving SelectedAntidepressants

97. A Dose Response Study of XXXXXX in the Treatment of GeneralizedAnxiety Disorder with Associated Depressive Symptoms

98. A Multicenter, Double-Blind Comparison of Efficacy and Safety of XXXXXX,Haloperidol, and Placebo in the Treatment of Elderly Subjects Residing inNursing Homes or Assisted Care Facilities and Presenting with Alzheimer’sDementia and Psychoses or Other Selected Psychoses

99. A Multicenter, Double-Blind, Placebo-Controlled, Randomized Fix DoseStudy of XXXXXX in the Treatment of Depressed Patients (2521)

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100. Long-Term Open Label Treatment with XXXXXX for Evaluation and Safety(Depression) (1743)

101. A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel-Group Study to Investigate the Tolerability and Efficacy of 12-WeekXXXXXX Once Daily Compared to Placebo in the Prophylaxis of MigraineHeadache Attacks in Adult Subjects with Migraine

102. Long-Term Safety of XXXXXX in the Treatment of Alzheimer's Disease

103. A Double-Blind, Placebo-Controlled Dose Finding Study Evaluating theSafety and Efficacy of XXXXXX in the Treatment of Major DepressiveDisorder (2553)

104. Safety and Efficacy of Long-Term Administration of XXXXXX in theTreatment of Major Depressive Disorder: A 4-Month Double-Blind Extensionto Study XXXXXX (2553X1)

105. Safety of Open-Label Standard Antidepressant Therapy in the Treatment ofMajor Depressive Disorder: A 1-Month Follow-Up After Termination of StudyXXXXXX (2553X2)

106. A Placebo-Controlled Study of XXXXXX and Alprazolam In Patients withGeneralized Anxiety Disorder (2597)

107. Open-Label Safety Study of XXXXXX In Patients with Anxiety Disorders(2387)

108. A Phase III at Home Use Study Evaluating the Efficacy and Safety ofEscalating Doses of XXXXXX in the Treatment of Patients with ErectileDysfunction (2406)

109. A Phase III Six Month, Long-Term, Open-Label, Flexible Dose, SafetyExtension Study of XXXXXX in the Treatment of Males Erectile Dysfunction(2406X1)

110. A Multicenter, Double-Blind Comparison of Efficacy and Safety of XXXXXX,Haloperidol, and Placebo in the Treatment of Elderly Subjects Residing inNursing Homes or Assisted Care Facilities and Presenting with Alzheimer'sDementia and Psychoses or other Selected Psychoses"

111. An Open-Label Long-Term, Safety Study of Transdermal XXXXXX in theTreatment of Anxious Outpatients

112. Evaluation of the Clinical Safety and Efficacy of XXXXXX In Patients withIntermittent

Claudication

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113. Effects of Prolonged Administration of XXXXXX and Progesterone on theIncidence of Endometrial Hyperplasia in Postmenopausal Patients

114. Comparative Study of XXXXXX and Ampicillin in the Treatment ofOutpatients with an Acute Bacterial Exacerbation of Chronic Bronchitis

115. XXXXXX in Rheumatoid Arthritis

116. A Phase III, 28-Day, Multicenter, Randomized, Double-Blind,Comparative-and Placebo-Controlled, Parallel-Group Safety, Tolerance andEfficacy Study of 5, 10 and 20 mg of XXXXXX, Compared with 10 mg ofZolpidem or Placebo, in Adult Outpatients with Insomnia

117. A Study to Evaluate the Safety and Tolerance of Long-Term Use of XXXXXXin the Treatment of Patients with Insomnia

118. An Open-Label, Long-Term, Safety Study of Transdermal XXXXXX in theTreatment of Anxious Outpatients

119. A Double-Blind, Randomized Trial of Three Fixed Doses of TransdermalXXXXXX Compared to Placebo in the Treatment of Anxious Outpatients

120. A Double-Blind, Randomized, Flexible Dose Trial of XXXXXX Transdermal orAlprazolam Compared to Placebo in the Treatment of Anxious Outpatients

121. A Placebo-Controlled Study of XXXXXX in patients With Social Phobia(2257A1)

122. A 10-Week, Randomized, Double-Blind, Placebo-Controlled Study ofXXXXXX and XXXXXX in Patients With Social Phobia (3315)

123. A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate theSafety and Efficacy of XXXXXX Therapy for Agitation in Nursing HomeResidents with Probable or Possible Alzheimer’s Disease (2860)

124. XXXXXX: Double-Blind, Placebo-Controlled, Dose-Response Study ofTolerability, Safety, and Efficacy in Patients with Early Parkinson’s Disease(3401)

125. XXXXXX: Open-Label, Long Term, Flexible Dose Study of Safety,Tolerability, and

Therapeutic Response in Patients with Parkinson’s Disease (3429)

126. A Double-Blind, Placebo-Controlled, Parallel-Group Comparison of XXXXXXExtended-Release Capsules and XXXXXX in Outpatients with GeneralizedSocial Anxiety Disorder. (2672)

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127. A Randomized, Double-Blind, Placebo-Controlled, Single-Attack, ParallelGroup Evaluation of XXXXXX 50mg and 100mg Versus Placebo During aMigraine Headache at the First Sign of Pain (2840)

128. A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel-Group Study to Evaluate the Safety and Efficacy of 12 Weeks of 2Oral Doses (200 mg and 400 mg Once Daily) of XXXXXX as Treatment forAdults with Excessive Daytime Sleepiness Associated with ObstructiveSleep Apnea/Hypopnea Syndrome Followed by a 9-Month Open-LabelExtension (2581)

129. Prospective, Randomized, Double-Blind, Multi-Center Comparison of thesafety and Efficacy of XXXXXX 400mg QD Five Days Versus XXXXXX500mg QD for Seven Days in the Treatment of Patients with AcuteExacerbation of Chronic Bronchitis (2444)

130. A Randomized, Single-Dose, Double-Blind, Parallel Study ComparingXXXXXX 20 mg, XXXXXX 10 mg and Placebo in Preventing HeartburnWhen Administered Immediately Prior to a Provocative Breakfast Meal(2666)

131. “A Double-Blind, Placebo-Controlled Study of XXXXXX in the Treatment ofBehavioral Agitation in Elderly Patients with Dementia (2637)

132. A Multicenter, Randomized, Double-Blind, Placebo Controlled Flexible DoseStudy of XXXXXX in the Treatment of Institutionalized Patients withPsychosis Associated with Dementia of the Alzheimer’s Type (2721)

133. A 1-Year, Double-Blind, Placebo-Controlled, Parallel Group Study toDetermine the Safety and Efficacy of XXXXXX in Patients WithEffort-Induced Chronic Stable Angina (2622)

134. Open-Label use of Synthetic XXXXXX in the Treatment of Alzheimer’sDisease (1138X1)

135. The Safety and Efficacy of XXXXXX 25 mg in Delaying the Progression ofthe Symptoms of Alzheimer’s Disease in Patients with Probable AD (2855)

136. XXXXXX: A 16-Week, Randomized, Double-Blind, Placebo-Controlled,Crossover, Multicenter Study of XXXXXX in Patients With Mild to ModerateAlzheimer’s Disease (2963)

137. A Phase III Double-Blind Efficacy and Safety Study of XXXXXX (10mg) inAddition to XXXXXX Compared to Placebo in Subjects with PrimaryHypercholesterolemia (2532)

138. A Double-Blind, Stratified, Randomized, Placebo-Controlled Study ofXXXXXX (also known as XXXXXX) in the Treatment of Influenza Infection inElderly Adults (2447)

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139. A Phase III Double-Blind Efficacy and Safety Study of XXXXXX (10mg) inAddition to XXXXXX in Subjects with Coronary Heart Disease or MultipleRisk Factors and with Primary Hypercholesterolemia Not Controlled by aStarting Dose (20mg) of XXXXXX (2692)

140. A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel-Group Study to Evaluate the Safety and Efficacy of 12 Weeks of 2Oral Doses (200 mg and 400 mg Once Daily) of XXXXXX as Treatment forAdults with Excessive Daytime Sleepiness Associated with ObstructiveSleep Apnea/Hypopnea Syndrome Followed by a 9-Month Open-LabelExtension (2581)

141. Efficacy and Safety of a Flexible Dose of XXXXXX Versus Placebo in theTreatment of

Psychosis of Alzheimer’s Disease (2956)

142. A Dose-Ranging, Double-Blind, Placebo-Controlled, Safety, Tolerability, andEfficacy Study of XXXXXX in Patients with Major Depressive Disorder ByDSM-IV Criteria. (3348)

143. A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study toEvaluate the Lipid-Altering Efficacy, Safety, and Tolerability of XXXXXXWhen Added to Therapy with an HMG-CoA Reductase Inhibitor XXXXXX inPatients with Primary Hypercholesterolemia with Known Heart Disease orMultiple Cardiovascular Risk Factors.” (3452)

144. A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study toAssess the

Efficacy and Safety of XXXXXX in Patients with Chronic Insomnia. (2973)

145. Evaluation of XXXXXX Placebo Controlled in the Treatment of Alzheimer’sDisease:

Safety and Efficacy of a Controlled Release Formulation. (2918)

146. A Randomized, Double-Blind, Placebo-Controlled, Dose Finding Study ofXXXXXX

(Topical Gel Formulation of XXXXXX and XXXXXX) for the Treatment ofMale ErectileDysfunction in an At-Home Setting. (3601)

147. An Open-Label Continuation Trial of 1% XXXXXX (Topical Gel Formulationof 1%

XXXXXX and 5% XXXXXX) in Male ED Patients Who Previously Participatedin XXXXXXStudy XXXXXX. (3601X1)

148. A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study toAssess Dose

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Response of XXXXXX in Subjects Transient Insomnia. (2580)

149. A Randomized Double-Blind Placebo-Controlled Trial to Evaluate theEfficacy and Safety of XXXXXX in Subjects with Mild Cognitive Impairment(MCI) Clinically at Risk for Development of Clinically Probable Alzheimer’sDisease. (2919)

150. An 8-Week, Double-Blind, Randomized, Multicenter, Flexible-Dose,Placebo-Controlled Study of XXXXXX in Patients with Panic Disorder. (3789)

151. A Randomized, 26-Week, Double-Blind, Placebo-Controlled Trial to Evaluatethe Safety And Efficacy of XXXXXX in the Treatment of Dementia Secondary toCerebrovascularDisease. (3666)

152. A Well-Controlled Safety and Efficacy Study of XXXXXX In Subjects withMild toModerate Alzheimer’s Disease. (3261)

153. A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study toAssess the Efficacy and Safety of XXXXXX in Elderly Patients with Chronic Insomnia.(3927)

154. A 6-Week, Double-Blind, Randomized, Multicenter, Fixed-Dose,Placebo-Controlled Study of XXXXXX Dosed Twice a Day in Patients with Generalized AnxietyDisorder. (3979)

155. An Open-Label Extension Trial to Assess the Long-Term Safety of aControlled Release Formulation of XXXXXX HBr in the Treatment of Alzheimer’s Dementia.(2918x1)

156. A Double-Blind, Randomized, Placebo-Controlled Surveillance Study ofAsthma Event Outcomes in Subjects Receiving Either Usual Pharmacotherapy ofAsthma or Usual Pharmacotherapy Plus XXXXXX 42mcg (2 Puffs) Twice Daily. (3963)

157. A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate theEfficacy and

Safety of XXXXXX in Subjects with Mild Cognitive Impairment (MCI)Clinically at Risk For Development of Clinically Probable Alzheimer’s Disease. (2920)

158. A Phase II, Randomized, Multicenter, Double-Blind, Placebo-Controlled,

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Twelve-Week, Safety and Tolerability Study of XXXXXX in Patients with Mild-to-ModerateDementia of

The Alzheimer’s Type. (3977)

159. A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safetyand Efficacy of

XXXXXX in Patients with Mild to Moderate Dementia of the Alzheimer’sType. (3811)

IND#: 33,392

160. A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study toAssess the

Efficacy and Safety of Modified Release Formulation of XXXXXX in ElderlyPatients with

Chronic Sleep Maintenance Insomnia. (4097)

161. A Long-Term, Open-Label Study of XXXXXX in Subjects with Mild toModerate

Alzheimer’s Disease. (3261x1)

162. Assessment of Variance in FDG-PET Measurement of CNS Effects inHealthy

Volunteers. (4082)

163. A Long-Term Extension Study Evaluating the Safety and Tolerability of BIDand QD

Administration of XXXXXX in Patients with Mild to Moderate of theAlzheimer’s Type.

(3811X1) 164. An Eight-Week, Double-Blind, Placebo-Controlled Multicenter Study toEvaluate the

Safety and Efficacy of 2 Doses of XXXXXX (1.5mg and 3.0mg) and XXXXXXin Subjects

With Major Depressive Disorder. (3495)

165. A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safetyand Efficacy

of XXXXXX in Patients with Mild to Moderate Dementia of the Alzheimer’sType.

IND#: 33,392 (4441)

166. A Phase II, Randomized, Double-Blind, 5-Way Cross-Over Study to Evaluatethe Efficacy

and Safety of XXXXXX (5,10 and 15 mg) and XXXXXX (10 mg) VersusPlacebo in a

Model of Transient Insomnia. A sleep Laboratory Study in HealthySubjects. (4485)

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167. XXXXXX 60 mg (or 30 mg) Once Daily in the Treatment of GeneralizedAnxiety Disorder.

An Open Multicenter Safety Study of 5 Months, Including a 1-MonthDrug-Free Follow-Up

Period. Follow-Up to Studies 3013023 and 3013025. (4458)

168. A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-GroupMulticenter

Study to Assess the Efficacy and Safety of XXXXXX in Adults with PrimaryInsomnia.

(4310)

169. XXXXXX 30 mg and 60 mg Once Daily Versus Placebo in GeneralizedAnxiety Disorder.

A Randomized Double-Blind Placebo and XXXXXX-Controlled Fixed-DoseParallel-

Group Multicenter Study of 10 Weeks (Including a 2-Week Single-BlindPlacebo Period).

(4128)

170. A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-GroupStudy to

Assess the Efficacy and Safety of XXXXXX for the Treatment of TransientInsomnia in

Adult Subjects. (4311)

171. An Open-Label Extension Trial to Assess the Safety of XXXXXX HBr in theTreatment of

Vascular Dementia. (4556)

172. A Randomized, Double-Blind, Single-Dose, Double-Dummy Evaluation ofthe Efficacy,

Safety and Pharmacokinetics of the Adenosine A1 Agonist, XXXXXX 100mg, and

XXXXXX 50 mg Versus Placebo in the Acute Treatment of Migraine. (4452)

173. A Phase III, Randomized, Double-Blind, Placebo-Controlled, OutpatientStudy to Assess

the Long-Term Safety and Efficacy of Two Dose Levels of XXXXXX in AdultPatients with

Primary Insomnia. (3934)

174. A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group,Multicenter

Study to Assess the Efficacy and Safety of a Modified Release Formulationof XXXXXX

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In Elderly Primary Insomnia Patients with Sleep Maintenance Difficulties.(4315)

175. A Multi-Center Study to Determine the Exposure of Adult U.S. Smokers toCigarette Smoke. (4625)

176. A Double-Blind, Placebo-Controlled Dose-Finding Study Evaluating theSafety and Efficacy of XXXXXX, 80mg bid, and 20 and 80 mg QD in the Treatment of Mild to ModerateAlzheimer’s Disease. (4807)

177. A Long-term, Open-label, Flexible-Dose Study of the Efficacy and Safety ofXXXX in Patients with Idiopathic Restless Legs Syndrome. (4382)

178. A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safetyand Efficacy of XXXX in Patients with Moderate to Severe Dementia of theAlzheimer’s Type. (4887)

179. A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safetyand Efficacy of XXXX in Patients with Moderate to Severe Dementia of theAlzheimer’s Type. (4988)

180. Pharmacogenomics Blood Sampling Protocol to Obtain DNA in a ReferencePopulation of Patients Diagnosed with Restless Legs Syndrome. (5152)

181. An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group,Flexible-Dosage Study to Evaluate the Efficacy and Safety of XXXX, atDosages up to 16mg/day, in the Treatment of Generalized AnxietyDisorder in Adults. (202359)

182. A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety ofXXXX, at Dosages up to 16mg/day in Adults with Generalized AnxietyDisorder. (202976)

183. An Evaluation of the Long-Term Safety and Efficacy of XXXX in Patientswith Moderate to Severe Dementia of the Alzheimer’s Type. (202891)

184. A Multicenter, Randomized, Double-Blind, Active and Placebo Controlled5-Way Crossover Study of the Safety and Efficacy of XXXX, Zolpidem, andPlacebo in Primary Insomnia. (5076)

185. A Phase III, Randomized, Double-Blind, Placebo-Controlled, OutpatientStudy to Assess the Efficacy and Safety of Two Dose Levels of XXXX inElderly Patients with Primary Insomnia. (3931)

186. A Phase III, Double-Blind, Outpatient, Extension Study to Assess theLong-Term Safety of Two Dose Levels of XXXX in Elderly Patients withPrimary Insomnia. (3931x1)

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187. A Randomized, Double-Blind, Placebo-Controlled, 4-Period-Cross-Over PilotStudy of the Safety and Efficacy of Multiple Doses of XXXX in Subjects withAlzheimer’s Disease. (202856)

188. An Open-Label Extension Study to Assess the Long-Term Safety andTolerability of XXXX HBr in the Treatment of Mild Cognitive Impairment.(5075)

189. A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-GroupStudy to Evaluate the Efficacy and Safety of XXXX (150 and 250 mg/day)as Treatment for Adults with Residual Excessive Sleepiness Associatedwith Obstructive Sleep Apnea/Hypopnea Syndrome. (203233)

190. A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-GroupStudy to Evaluate the Efficacy and Safety of XXXX (150 and 250 mg/day)as Treatment for Adults with Excessive Sleepiness Associated withNarcolepsy. (203231)

191. A One Year, Multicenter, Randomized, Double-Blind, Placebo-ControlledEvaluation of the Efficacy and Safety of XXXX in Subjects with MildCognitive Impairment. (202493)

192. A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 18-MonthStudy of the Efficacy of XXXX in Patients with Mild-To-Moderate Dementiaof the Alzheimer’s Type. (202793)

193. A Randomized, Double-Blind, Placebo-Controlled Trial of XXXX to Attenuatethe Progression of Alzheimer’s Disease. (202530)

194. A Randomized, Double-Blind, Placebo-Controlled, Parallel Group,Multicenter, Fixed-Dose, Polysomnographic Study of XXXX in Patients withPrimary Insomnia. (202700)

195. A Multicenter, Randomized, Open-Label Study Evaluating the Effects ofXXXX, 80 mg b.i.d., vs. XXXX, 5 or 10 mg, on Adrenal Function in Patientswith Mild Alzheimer’s Disease. (202538)

196. A 12-Month, Open-Label, Flexible-Dosage (100-250 mg/day) ExtensionStudy of XXXX in the Treatment of Patients with Excessive SleepinessAssociated with Narcolepsy, Obstructive Sleep Apnea/HypopneaSyndrome, or Chronic Shift Work Sleep Disorder. (203903)

197. A Double-Blind, Phase II, Safety and Efficacy Evaluation of XXXX inPatients with Mild to Moderate Alzheimer’s Disease. (203096PRN)

198. A Phase III Study of the Efficacy and Safety of XXXX in Patients with Mild toModerate Alzheimer’s Disease. (203077PRN)

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199. A Randomized, Double-Blind, Placebo-Controlled Study to Assess theSafety and Efficacy of Once Daily XXXX in Patients with Restless LegsSyndrome. (00036)

200. A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate theSafety and Efficacy of XXXX 25 mg in Slowing the Progression ofAlzheimer’s Disease. (202531)

201. A Long-Term Safety and Efficacy of Open-Label XXXX, 80 mg b.i.d. in theTreatment of Probable Alzheimer’s Disease: A 18-month Follow-Up AfterCompletion of Study XXXX. (202859)

202. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IIStudy of Efficacy and Safety of XXXX in Subjects with Mild to ModerateAlzheimer’s Disease. (00012)

203. A Study To Define The Non-Restorative Sleep Population. (00010)

204. A Randomized, Double-Blind, Placebo-Controlled Trial of XXXX to Attenuatethe Progression of Alzheimer’s Disease. (00026)

205. A 6-Month Safety Follow-Up Study of Select Patients Previously Enrolledand Randomized to XXXX in Studies XXXX, XXXX or XXXX. (00028)

206. Evaluation of the Long-Term Efficacy and Safety of XXXX 12.5 mgCompared to Placebo, When Both are Administered Over a Long-TermPeriod “as needed”, in Patients with Chronic Primary Insomnia. (ARandomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter,Phase IIIb Clinical Study). (00007)

207. A Randomized, Double-Blind, Placebo-Controlled, Crossover Study toAssess the Efficacy and Safety of XXXX in Patients with Restless LegsSyndrome. (203812PRN)

208. A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled,Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic,Pharmacodynamic, and Immunogenicity Trial of XXXX in Patients with Mildto Moderate Alzheimer’s Disease. (00025)

209. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group study ofthe efficacy, safety and tolerability of XXXX in Patients with GeneralizedAnxiety Disorder. (00054)

210. A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Five-ArmParallel-Group Trial to Investigate the Efficacy and Safety of Four DifferentTransdermal Doses of XXXX in Subjects with Idiopathic Restless LegsSyndrome. (00046)

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211. A 12 Week, Double-Blind, Placebo Controlled, Parallel Group to Assess theEfficacy and Safety of XXXX XR (Extended Release) in Patients withRestless Legs Syndrome. (00059)

212. Phase 3 Multicenter, Randomized, Double Blind, Placebo Controlled Studyof the Effect of Daily Treatment with XXXX on Measures of Cognition,Activities of Daily Living and Global Function in Subjects with MildDementia of the Alzheimer’s Type. (00023)

213. The Efficacy of XXXX 3mg as Adjunctive Therapy in Subjects with InsomniaRelated to Generalized Anxiety Disorder. (00057)

214. A Double Blind, Placebo Controlled Study of XXXX for the Treatment ofMild-To-Moderate Alzheimer’s Disease. (00065)

215. A Double-Blind, Randomized, Placebo-Controlled, Phase IIa, Multiple Dose,Multicenter Study in Patients with Mild to Moderate Dementia of theAlzheimer’s Type to Evaluate the Safety and Tolerability of Two 10-WeekDose Regimens of Orally-Administered XXXX. (00063)

216. A Phase III, Randomized, Double-Blind, Placebo-Controlled,Polysomnographic Study to Assess the Efficacy and Safety of a ModifiedRelease Formulation of XXXX in Primary Insomnia Patients with SleepMaintenance Difficulties. (00047)

217. An Open-Label Extension of the Phase III Study XXXX with XXXX inPatients with Alzheimer’s Disease. (00107)

218. A 52-Week, Open-Label Study to Assess the Long-Term Safety of XXXXExtended Release (XR) in Patients with Restless Legs Syndrome (RLS).(00075)

219. A Randomized, Double-Blind, Placebo-Controlled, Multi-Center,Parallel-Group Study to Evaluate the Efficacy and Safety of XXXX inMigraine Prophylaxis. (00082)

220. A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate theEffects of XXXX on Cognitive Functions in the Elderly. (00058)

221. A Randomized, Double-Blind, Placebo-Controlled Study to Assess theEfficacy and Safety of XXXX in Patients with Restless Legs Syndrome.(00056)

222. An Open-Label, 52-Week Extension Study Assessing XXXX Safety andEfficacy in Patients with Restless Legs Syndrome. (00114)

223. A 54-Week , Double-Blind, Randomized, Placebo-Controlled, Parallel-GroupStudy to Investigate the Effects of XXXX (extended release tablets) asAdjunctive Therapy to Acetylcholinesterase Inhibitors on Cognition and

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Overall Clinical Response in APOE E4-Stratified Subjects with Mild toModerate Alzheimer’s Disease. (00123)

224. A Multi-Center, Double-Blind, Parallel Group, Fixed Dose, 4-Arm, Placeboand Paroxetine Controlled 8-Week Efficacy Study of 2 Oral Doses of XXXX(175mg or 350mg, bid) in Adult Outpatients with Major DepressiveDisorder. (00022)

225. Phase 3 Multinational, Randomized, Double-Blind, Placebo-ControlledStudy of the Effect of Daily Treatment with XXXX on Measures ofCognition, Activities of Daily Living and Global Function in Subjects withMild Dementia of the Alzheimer’s Type. (00128)

226. A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study toAssess the Efficacy, Safety and Pharmacokinetics of XXXX in Patients withRestless Legs Syndrome. (00141)

227. Open Label Study of the Effect of Daily Treatment with XXXX in Subjectswith Dementia of the Alzheimer’s Type. (00139)

228. An 8-Week, Randomized, Double-Blind, Fixed-Dosage, Placebo-Controlled,Parallel-Group, Multi-Center Study of the Efficacy, Safety and Tolerability ofXXXX 25 mg and 50 mg in the Treatment of Major Depressive Disorder(MDD) Followed by a 52-Week, Open-Label Extension (XXXX). (00125)

229. An Open-Label Extension Trial to Investigate the Safety and Tolerability ofLong-Term Treatment with Transdermal XXXX in Subjects with IdiopathicRestless Legs Syndrome. (00093)

230. A 28-Week Open Label Extension Study Evaluating the Safety andTolerability of XXXX (XXXX) in Subjects with Mild Cognitive Impairment.(00105)

231. A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study toEvaluate the Effects of XXXX (2.5, 10 and 30mg) on PolysomnographicSleep Recordings, Subjective Sleep Assessment, and Daytime CognitiveFunction in Elderly and Non-Elderly Subjects with Primary Insomnia.(00088)

232. A Randomized, Double-Blind, Placebo Controlled, Cross-Over Study toEvaluate Effects of the XXXX in Patients with Insomnia. (00077)

233. A Randomized, Double-Blind Comparison of 5mg of XXXX, 15 mg of XXXX,and Placebo in the Treatment of Patients with Primary Insomnia. (00076)

234. A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study toDemonstrate the Subjective Treatment Effects of XXXX on Sleep Using aPost Sleep Questionnaire-Interactive Voice Response System (PSQ-IVRS) in

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an “At-Home Setting” in an Adult Population with Chronic Insomnia.(00145)

235. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, ParallelStudy to Investigate the Efficacy and Safety of a Single Oral Dose of XXXX(20, 50, and 100 mg) and Matching Placebo in Healthy Male and FemaleSubjects with Induced Transient Insomnia. (00107)

236. Efficacy and Safety of XXXX 5mg/day on Sleep Maintenance Insomnia: A6-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study.(00103)

237. A Randomized, Double-Blind, Placebo and Active Controlled, Multi-Center,Proof of Concept Trial of XXXX in Subjects with Non-Restorative Sleep.(00095)

238. Effect of XXXX in Slowing the Progression of Alzheimer’s Disease. (00134)

239. A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy,Safety and Tolerability of 8 Week Treatment of XXXX 8 mg (QHS) in SleepDisturbed, Mild to Moderately Severe Alzheimer’s Disease Subjects.(00090)

240. A Phase 2, Double-Blind, Placebo-Controlled Study to Evaluate the Safety,Tolerability, and Effect on Cognitive Function of XXXX After 12 Weeks ofIntranasal Administration in Subjects with Mild Cognitive Impairment.(00163)

241. A Six-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel Group,Efficacy and Safety, Sleep Lab Trial with XXXX in Patients with ChronicPrimary Insomnia. (00118)

242. A Randomized, Double-Blind, Placebo-Controlled, Parallel, Proof of ConceptStudy to Evaluate the Effectiveness of XXXX to Advance the Timing ofSleep in Individuals with Delayed Sleep Phase Syndrome (DSPS). (00198)

243. A Randomized, Double-Blind, Placebo-Controlled, Phase IIa Study toAssess the Short-Term Effects of XXXX Alone and in Combination withDonepezil in Subjects with Mild Alzheimer’s Disease. (00144)

244. Efficacy and Safety of 2 mg/Day XXXX on Sleep Maintenance Insomnia: A6-Week, Multicenter, Randomized, Double-Blind, Placebo-ControlledPolysomnographic Study. (00192)

245. A Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group,Dose-Ranging Study Assessing the Efficacy and Safety of XXXX TabletsTwice Daily in Adults with Mild to Moderate Alzheimer’s Disease. (00214)

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246. Fifty-Two Weeks, Open-Label Extension Trial to Evaluate Safety andEfficacy of XXXX in Outpatients with Chronic Primary Insomnia WhoCompleted Clinical Trial Protocol 176001 or 176002. (00217)

247. A Randomized, Double-Blind, Active- and Placebo-Controlled, ParallelGroup Safety Study Assessing Simulated Driving Performance in XXXX-Treated Patients with Restless Legs Syndrome. (00227)

248. XXXX Dose-Ranging Trial: A Randomized, Double-Blind,Placebo-Controlled, 5-Way Crossover, Multicenter Polysomnography Trial ofXXXX in Adults with Primary Insomnia. (00284)

249. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, ParallelStudy to Investigate the Efficacy and Safety of XXXX (20 MG/Day and 50MG/Day) in the Treatment of Primary Insomnia. (00273)

250. A 52-Week Open-Label Extension Study of the Long-Term Safety andEfficacy of XXXX Extended-Release (RSGXR) as Adjunctive Therapy toAcetylcholinesterase Inhibitors in Subjects with Mild-To-ModerateAlzheimer’s Disease (AVA102675, REFLECT-4). (00220)

251. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3Study of XXXX in Adult Migraineurs for a Single Migraine Followed byOpen-Label Extensions to 26/52 Weeks. (00219)

252. A Double-Blind, Randomized, Placebo-Controlled Study Examining, theSafety, Efficacy and Tolerability of XXXX in Subjects with Major DepressiveDisorder (including Atypical and Melancholic Features). (00230)

253. A Phase 3, Randomized, Double-Blind, Placebo Controlled, Parallel Group,10-Week Study Evaluating the Efficacy and Safety of XXXX For theTreatment of Generalized Anxiety Disorder. (00275)

254. A Randomized, Long-Term Safety Study of XXXX in Elderly Outpatientswith Chronic Primary Insomnia Examining the Effects of 1.5 mg or 3.0 mgof XXXX. (00226)

255. A Randomized, Double-Blind, Placebo-Controlled Subjective Study toAssess the Efficacy of XXXX in Patients with Primary InsomniaCharacterized by Difficulty Maintaining Sleep. (00324)

256. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study toEvaluate the Efficacy and Safety of XXXX at a Target Dosage of 200mg/day as Treatment for Adults with Excessive Sleepiness Associated withObstructive Sleep Apnea/Hypopnea Syndrome With Comorbid MajorDepressive Disorder or Dysthymic Disorder. (00323)

257. Effect of y-Secretase Inhibition on the Progression of Alzheimer’s Disease:XXXX Versus Placebo. (00294)

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258. XXXX Dose-Ranging Trial: A Randomized, Double-Blind, Parallel Group,Placebo-Controlled, Multicenter Outpatient Trial of XXXX in Adults withNon-Restorative Sleep. (00321)

259. A Phase 2a Multi-Center, Randomized, Double Blind, Placebo-ControlledStudy to Investigate the Efficacy and Safety of XXXX in Patients with Mildto Moderate Alzheimer’s Disease. (00318)

260. A Double-Blind, Placebo-Controlled, Randomized, Multicenter StudyEvaluating the Efficacy and Safety of Eighteen Months of Treatment withXXXX (XXXX) in Participants with Mild-To-Moderate Alzheimer’s Disease.(00355)

261. A Polysomnography Study of XXXX (XXXX) Extended Release TabletsVersus Placebo in the Treatment of Restless Legs Syndrome (RLS) andAssociated Sleep Disturbance. (00338)

262. A Randomized, Double-Blind, Placebo-Controlled, Ascending-Dose Phase1b Safety Study of Three Different Doses of an Alpha-7 NicotinicAcetylcholine Receptor Agonist (XXXX) or Placebo in Patients with Mild toModerate Probable Alzheimer’s Disease. (00343)

263. A 52 Week Open Label Safety Study of XXXX in Subjects with GeneralizedAnxiety Disorder. (00305)

264. Efficacy and Safety of XXXX 5mg/Day in Insomnia Characterized by SleepMaintenance Difficulties: A 6-Week, Randomized, Double-Blind,Placebo-Controlled, Polysomnography Study. (00350)

265. A Phase 2 Study of XXXX Compared with Placebo for the Treatment ofAlcohol Dependence. (00347)

266. A Randomized, Double-Blind, Placebo-Controlled, Functional NeuroimagingStudy of the Effects of XXXX (200mg/Day) Treatment on Prefrontal CorticalActivation in Patients with Residual Excessive Sleepiness Associated withObstructive Sleep Apnea/Hypopnea Syndrome. (00407)

267. A Phase 3 Multicenter, Randomized, Placebo-Controlled, Twelve-MonthSafety and Efficacy Study Evaluating XXXX in Patients withMild-To-Moderate Alzheimer’s Disease on Donepezil. (00404)

268. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of theSafety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects ofXXXX in the Treatment of Patients with Mild to Moderate Alzheimer’sDisease. (00341)

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269. A Double-Blind, Placebo-Controlled Preliminary Study of the Efficacy,Safety and Tolerability of XXXX in the Treatment of Alzheimer’s Disease.(00382)

270. A Double-Blind, Placebo-Controlled Preliminary Study of the Efficacy,Safety and Tolerability of XXXX in the Treatment of Alzheimer’s Disease inSubjects Concurrently Receiving Donepezil (Aricept®). (00403)

271. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of theSafety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects ofXXXX in the Treatment of Patients with Prodromal Alzheimer’s Disease.(00412)

272. Randomized, Double-Blind, 12-Month Study of XXXX in Subjects withRestless Legs Syndrome. (00418)

273. An Open Label Study of the Safety and Tolerability of XXXX in Subjectswith Alzheimer’s Disease. (00446)

274. A Phase 2 Multicenter, Double-Blind, Placebo-Controlled, Parallel GroupStudy of XXXX in Subjects with Mild to Moderate Alzheimer’s Disease.(00440)

275. A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group,Fixed-Dosage Study to Evaluate the Efficacy and Safety of XXXX (50, 150and 250 mg/day) as Treatment for Patients with Excessive SleepinessAssociated with Mild or Moderate Closed Traumatic Brain Injury. (00397)

276. A 12-Month, Open-Label Study to Evaluate the Safety, Tolerability, andEfficacy of XXXX (150 and 250 mg/Day) as Treatment for Patients withExcessive Sleepiness Associated with Mild or Moderate Closed TraumaticBrain Injury. (00506)

277. Open-Label Extension for Alzheimer’s Disease Patients Who Complete Oneof Two XXXX Phase 3 Double-Blind Studies (H6L-MC-LFAN orH6L-MC-LFBC). (00516)

278. A Randomized, Double-Blind, Placebo-Controlled, 3-Way Crossover,Multicenter Polysomnography Study of XXXX and XXXX in Adults withRestless Legs Syndrome. (00457)

279. Effect of Passive Immunization on the Progression of Alzheimer’s Disease:XXXX (XXXX) Versus Placebo. (00503)

280. A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel-Group, Long-Term Safety Study of XXXX in Patients with PrimaryInsomnia. (00448)

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281. A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group, Study to Evaluate the Safety and Efficacy of XXXX inPatients with Primary Insomnia – Study A. (00514)

282. An Open-Label Extension of the CONCERT Protocol (DIM18) EvaluatingXXXX (XXXX) in Patients with Alzheimer’s Disease. (00529)

283. A Worldwide, Randomized, Double Blind, Placebo-Controlled, ParallelGroup Clinical Trial to Evaluate the Safety and Efficacy of XXXX for theAcute Treatment of Migraine in Children and Adolescents. (00502)

284. A Worldwide, Open Label, Clinical Trial to Examine the Long Term Safetyand Tolerability of XXXX in Pediatric Migraineurs for the Treatment ofMigraine With or Without Aura. (00469)

285. Randomized, Double-Blind, 12-Week Study of XXXX in Subjects withRestless Legs Syndrome. (00515)

286. Continued Efficacy and Safety Monitoring of XXXX, an Anti-Amyloid βAntibody in Patients with Alzheimer’s Disease. (00565)

287. A Multiple Dose Study of the Safety, Tolerability, Pharmacokinetic andPharmacodynamic Effects of XXXX Administered Once Daily to Subjectswith an Excessive Daytime Sleepiness Disorder. (00541)

288. A 4-Week, Randomized, Double-Blind, Parallel Group, Placebo ControlledStudy to Investigate the Safety and Efficacy of XXXX as Monotherapy inPatients with Treatment-Resistant Major Depression. (00585)

289. A Randomized, Double-Blind, Placebo-Controlled, Combined SingleAscending Dose and Multiple Ascending Dose Study to Assess Safety,Tolerability, Immunogenicity, Pharmacodynamic Response, andPharmacokinetics of Intravenous Infusions of XXXX in Subjects with Mild toModerate Alzheimer’s Disease. (00582)

290. A Phase 2, 24-Month, Multi-Center, Randomized, Double-Blind,Placebo-Controlled, Parallel-Group, Amyloid-Imaging Positron EmissionTomography (PET) and Safety Study of XXXX and XXXX Adjuvant inSubjects with Mild to Moderate Alzheimer’s Disease. (00591)

291. A Multicenter, Randomized, Double-Blind, Active-Controlled Study of theEfficacy and Safety of Flexibly-Dosed XXXX in Patients with TreatmentResistant Major Depression. (00571)

292. A Phase 2, Multicenter, Open-Label Study to Assess the Safety andTolerability of Oral XXXX as Adjunctive Therapy in Adult Patients withMajor Depressive Disorder. (00416)

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293. A Randomized, Double Blind, Placebo-Controlled Efficacy and Safety Studyof XXXX in Subjects with Spasticity Due to Multiple Sclerosis. (00595)

294. An Open Label, 26-Week Study Assessing XXXX Safety and Efficacy inSubjects with Spasticity Associated with Multiple Sclerosis. (00614)

295. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group,Multicenter, Phase II Study to Evaluate the Efficacy and Safety of XXXX inPatients with Mild to Moderate Alzheimer’s Disease. (00579)

296. A Multicenter, Double-Blind, 58-Week Rollover Study to Assess the Safetyand Tolerability of XXXX in Patients with Treatment Resistant MajorDepression. (00583)

297. A Study to Evaluate the Effects of XXXX in Patients with ChronicObstructive Pulmonary Disease. (00619)

298. A Phase 1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled,Sequential Dose Study of the Safety and Tolerability of XXXX in Subjectswith Alzheimer’s Disease on Donepezil. (00618)

299. A Double-Blind, Parallel Group, Randomized, Placebo Controlled SleepLaboratory Study of Efficacy and Safety of XXXX in Insomnia Patients Aged18-80. (00635)

300. A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of theSafety and Effectiveness of XXXX (Human), 10% Solution (XXXX, 10%) forthe Treatment of Mild to Moderate Alzheimer’s Disease (AD). (00626)

301. A Phase IIa Safety and Tolerability Study to Investigate the Effect on Sleepof 3 Doses of XXXX and Placebo in Patients with Mild Alzheimer’s Diseaseand Mild Cognitive Impairment During 4 Weeks of Treatment, Designed asa Randomized, Double-Blind, Multi-Center, Parallel Group,Placebo-Controlled Study. (00658)

302. Effect of XXXX in Obese Subjects with Moderate or Severe ObstructiveSleep Apnoea A 32-Week Randomized, Double-Blind, Placebo-Controlled,Parallel Group, Multi-Center and Multinational Trial. (00696)

303. A Phase 2, Randomized, Double-Dummy, Double-Blind, Placebo-ControlledStudy to Assess the Efficacy, Safety and Tolerability of XXXX (XXXX/XXXX)for the Treatment of Symptoms of Agitation in Patients with Alzheimer’sDisease. (00697)

304. A Randomized, Double-Blinded, Placebo-Controlled Multiple Dose Study toAssess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamicsof XXXX in Subjects with Prodromal or Mild Alzheimer’s Disease. (00700)

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305. A Multicenter, Open-Label, Long-Term Safety Extension of Phase II StudiesABE4869g and ABE4955g in Patients with Mild to Moderate Alzheimer’sDisease. (00729)

306. Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 18-MonthSafety and Efficacy Study of XXXX in Subjects with Mild Alzheimer’sDisease. (00722)

307. A Twelve-week, Double-Blind, Placebo-Controlled, Randomized,Parallel-Group, Multi-Center Study of the Safety and Efficacy of XXXX inthe Treatment of Excessive Daytime Sleepiness in Subjects withNarcolepsy. (00733)

308. A 26-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel-GroupStudy to Investigate the Effects of Daily Administration of XXXX inParticipants with Mild to Moderate Alzheimer’s Disease (AD) with anOptional 26-Week Open-Label Extension. (00731)

309. A Double-Blind, Randomized, Placebo Controlled, Parallel Group Study toSimultaneously Qualify a Biomarker Algorithm for Prognosis of Risk ofDeveloping Mild Cognitive Impairment due to Alzheimer’s Disease (MCIdue to AD) and to Test the Safety and Efficacy of XXXX (XXXX SR 0.8 mgQD) to Delay the Onset of MCI due to AD in Cognitively Normal Subjects.(00678)

310. A Phase 3, 12-Week, Multicenter, Randomized, Double-Blind,Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Tolerability of3 Fixed Doses of XXXX (XXXX) in the Treatment of Subjects with AgitationAssociated with Dementia of the Alzheimer’s Type. (00756)

311. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 26-Week,Phase 3 Study of Two Doses of XXXX or Placebo in Subjects with Mild toModerate Alzheimer’s Disease Currently or Previously Receiving anAcetylcholinesterase Inhibitor Medication. (00734)

312. A Randomized, Partially Blind, Placebo-Controlled, Proof-of-Concept Studyto Assess the Effect of a Single Infusion of XXXX on Disease Activity asMeasured by Brain MRI Scans in Patients. (00775)

313. Effect of Passive Immunization on the Progression of Mild Alzheimer’sDisease: XXXX (XXXX) Versus Placebo. (00743)

314. A Phase II, Randomized, Multi-Center, Parallel-Group, Rater-Blinded Studyto Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mgand 20 mg XXXX Doses. (00767)

315. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Proof ofConcept Study to Evaluate the Effect of XXXX in Obsessive Compulsive

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Disorder (OCD) Patients Resistant to Selective Serotonin ReuptakeInhibitor (SSRI) Therapy. (00774)

316. A One Year, Open Label, Dose Escalation Study to Evaluate the Long-TermSafety of XXXX Extended Release Tablets in Multiple Sclerosis Subjectswith Spasticity. (00801)

317. A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel-Group, Bayesian Adaptive Randomization Design, Dose ResponseStudy of the Efficacy of XXXX in Adults and Elderly Subjects with ChronicInsomnia. (00739)

318. Interventional, Open-Label, Flexible-Dose, Exploratory Study of XXXX asAdjunctive Treatment of Sleep Disturbances in Patients With MajorDepressive Disorder. (00761)

319. Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 15-MonthTrial of XXXX (XXXX) in Subjects With Mild to Moderate Alzheimer’sDisease. (00725)

320. A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group,Multicenter Efficacy and Safety Study of XXXX in Patients with MildAlzheimer’s Disease. (00791)

321. A Double-Blind, Randomized, Placebo-Controlled, Parallel Group Trial toEvaluate the Duration of Action of XXXX Capsules (XXXX) in Subjects withSpasticity Due to Multiple Sclerosis (MS). (00804)

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