Curriculum Vitae

Joseph Leonard Lillo, DO, FNLA, FAPCR, CPI

Dr. Joseph Lillo has participated in clinical research studies for nearly 30 years in hundreds of clinical trials.

He has been a practicing physician in Arizona for nearly 40 years and currently has nearly 12,000 patients. He is a Board-Certified Family Practice Physician and a Board-Certified Lipidologist.

He is a Certified Principal Investigator and a Fellow of the National Lipid Association in the USA.

His goals are to provide the highest quality medical care and perform the highest quality research.

He has a passion for future clinical research being a Certified Principal Investigator and as one of the Top Docs in Arizona!

Education

High School

School: Mesa High School, Mesa, Arizona
Graduation: Graduated with Highest Honors, 1972

Undergraduate

Institution: Arizona State University, Tempe, Arizona
Degree: B.S. Zoology
Honors: Graduated in absentia, with Distinction, 1976

Medical School

Institution: Kirksville College of Osteopathic Medicine and Surgery
Degree: Doctors of Osteopathic Medicine, 1979
Location: Kirksville, Missouri

Internship

Institution: Phoenix General Hospital
Program: Rotating Internship, 1979-1980
Location: Phoenix, Arizona

Certifications

Board Certified in Clinical Lipidology – National Lipid Association, 2005, Phoenix, Arizona
Certified Physician Investigator (CPI) – Association of Clinical Research Professionals, 2013, Phoenix, Arizona

Professional Experience

Current Positions

Family Physician at Intracare Health Center, Scottsdale, AZ (2024 – Present)
Certified Principal Investigator at Research Specialists of America, LLC, Phoenix, AZ (2024 – Present)
Certified Principal Investigator at Elite Clinical Studies, LLC, Phoenix, AZ (2009 – Present)

Previous Positions

Family Physician at Lillo Family Medicine, Scottsdale, AZ (2019 – 2024)
Principal Investigator at Research Specialists of Arizona, LLC, Phoenix, AZ (2016 – Present)
Chairman, Department of Family Practice at Scottsdale Healthcare Osborn (2001 – 2019)
Medical Director at Scottsdale Healthcare Osborn (1998 – 2000)
Medical Director at Wellness, Inc. (1999 – 2007)
Credentials Committee Chairman at Tempe St. Luke’s Hospital (1994 – 1995)
Physician and Surgeon at Medical Arts, P.A. (1980 – 2002)
Physician and Surgeon at Scottsdale Family Health, PLLC (2002 – Present)

Honors and Awards

Fellow of the National Lipid Association (NLA), April 2012
Who’s Who in America, 1998 & 1999
Phoenix Magazine Super Docs, 2012
National Lipid Association President’s Service Award, 2013

Speaking and Academics

Teaching Faculty, Bristol-Meyers Squibb National Sales Representative Training Program (1991 – 1992)
Guest Speaker, various pharmaceutical conferences and training sessions
Adjunct Assistant Professor of Family Medicine, KCOM (2001 – 2002)
Assistant Professor of Family Medicine, Midwestern College of Osteopathic Medicine (2000 – Present)
Lecturer, Family Practice Residency Training program at Tempe St. Luke’s and Mesa General Hospitals

Publications

Contributions to journals such as the Journal of the American Osteopathic Association, Osteopathic Family Physician News, and more.

Licensure and Certifications

Medical License, Arizona (1980 – Present)
Board Certified in Family Practice, American Osteopathic Board of Family Physicians (1990)
Continuing Medical Education Certification, American Osteopathic Association (1980 – Present)

Current Hospital Privileges

Scottsdale Healthcare Osborn
Scottsdale Healthcare Shea

Organizational Memberships

American Osteopathic Association
American College of Osteopathic Physicians
Arizona Osteopathic Medical Association, and more.

Volunteer Work

Mission of Mercy, Free Medical Clinic (1997 – 2002)
American Cancer Society, Board of Directors, Scottsdale (1987 – 1993)

RESEARCH EXPERIENCE:

Randomized, Double-Blind, Placebo-Controlled, Parallel Design Multiple-Site Study to Evaluate the Clinical Equivalence of two ***0.3% ****0.1% Sterile Otic Suspensions in the Treatment of Acute Bacterial Otitis Externa.

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial Of ****Administered Orally for 12 Weeks

followed by a 4-Week Randomized Withdrawal Period in Patients with Irritable Bowel Syndrome with Constipation.

A Multi-Center, Randomized, Double-Blind (with In-House Blinding), Active-Controlled, Parallel-Group Clinical Trial to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Oral **** in Adults with Acute Migraine with or Without Aura.

A Phase 3, Multi-Center, Randomized, Double-Blind, Controlled Study of the Long-term Analgesic Efficacy and Safety of ****Alone or in Combination with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) alone in Patients with Osteoarthritis of the Knee or Hip.

A Multi-Center, Randomized, Active Controlled Study to Investigate the Efficacy and Safety of Intravenous ****, **** In Patients with Iron Deficiency Anemia (IDA).

An Open-Label, Long-Term Safety Study of Oral **** Administered to Patients with Chromic Constipation or irritable bowel syndrome with Constipation.

Randomized Evaluation of Efficacy and Safety of **** **** in Patients with Iron Deficiency Anemia and Impaired Renal Function.

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment with **** in addition to Stand of Care in Subjects with Type 2 Diabetes and Acute Coronary Syndrome.

A Study of **** (******) for Prevention of Menstrually Related Migraine in Female Patients.

A Randomized, Active-controlled, Double-Blind, Double-Dummy, Parallel Group Design, Multi-Center Trial to Compare the Efficacy and Safety of **ug and ** ug****Inhalation Solution Delivered by the **** Inhaler with **** Inhalation Capsules**ug Delivered by the ****.

A Randomized, Double-Blind, Placebo-Controlled Study Evaluation the Efficacy, Safety and Tolerability of 2 Doses of **** **** 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 **** **** Dose.

An Open-Label, Long-Term Safety Study of Oral **** Administered to Patients with Chronic Constipation or irritable bowel syndrome with Constipation.

A Multicenter, Randomized, Active-Control, Phase 3B Study to Evaluate the Cardiovascular Safety of **** and **** in Subjects with Gout and Cardiovascular Comorbidities.

A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either **** or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of **** in the Treatment of Patients with Irritable Bowel Syndrome with Diarrhea.

A Study of **** (**-****) for Prevention of Menstrually Related Migraine in Female Patients.

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of 2 Doses of **** **** 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 **** **** Dose.

A Long-Term, Randomized, Study of the Safety and Tolerability of a Fixed-Dose Combination of ****/**** **** compared with **** **** in Patients with Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD).

A Phase III, Long-Term, Randomized, Double-Blind, Extension Study of the Efficacy, Safety and Tolerability of Two Fixed Dose Combination of **** ****/**** ****, **** ****, **** **** and Placebo for 28-Weeks Treatment in Patients with Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD).

A 52-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of **** 500 ug on Exacerbation Rate in Patients with Chronic Obstructive Pulmonary Disease (COPD) Treated with a Fixed-Dose Combination of Long-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS).

A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of 17 Weeks of weekly Injections of **** in Patients with Type 2 Diabetes Mellitus on Metformin Monotherapy.

A Phase 2, Randomized, Double-Blind, Placebo Controlled, Multicenter Study Evaluating the Efficacy and Safety of Two Doses of **** in Adult Patients with Uncomplicated Influenza.

A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Study Comparing **** Topical Gel 1% (**** **** ****) to **** (**** gel) 1% (****) in the Treatment of Moderate to Severe Rosacea.

A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Evaluate the Clinical Equivalence of **** 24 mcg Capsules (**** ****, Inc.) with **** (****) 24 mcg Capsules (**** ****, Inc.) in the Treatment of Idiopathic Constipation.

A Phase 3B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of **** Administered Orally for 12 Weeks to Patients with Chronic Constipation and Prominent Abdominal Bloating at Baseline/****.

A Phase 4, Multi-County Multi-Center, Randomized, Open-Label, Parallel Study in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Basal Insulin and Oral Anti-hyperglycemic Medications, Comparing the Efficacy and Safety of Initiating and Intensifying Insulin **** Mealtime Bolus Therapy in Addition to Insulin **** Basal Therapy Using Two Different Treatment Algorithms (Titration of Bolus Therapy every 3 Days Versus Every Day). Including a 6-Week Lead-in Period for Subjects Requiring **** Optimization and/or Randomization to a Bolus Treatment Algorithm for 24 Weeks of Treatment.

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of **** in Patients with Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-Rheumatic Drug (DMARD) Therapy (FLEX O).

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 8-Week Study to Evaluate the Safety and Efficacy of **** and **** Given as a Fixed-Dose Combination in Patients with Stage 1 or 2 Essential Hypertension.

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of **** in Patients with Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-Rheumatic Drug (DMARD) Therapy.

A Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Study Comparing **** **** Cream 1% (**** ****, Inc.) to ****(**** **** cream) Cream 1% (****) in the Treatment of Tinea Pedis.

A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Evaluate the Clinical Equivalence of **** **** 1% Gel (**** ****, Inc.) With **** Gel (**** **** Topical Gel) 1% (****) in Patients with Osteoarthritis of the Knee.

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of **** in Patients with Moderate to Severe Rheumatoid Arthritis (RA) Who had an Inadequate Response to **** Therapy.

A Randomized, Long-term, Open-Label, 3–ARM, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of **** Once Weekly Suspension to **** and Placebo in Subjects with Type 2 Diabetes Mellitus.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Therapy with **** added to **** in Combination with Metformin compared to Therapy with Placebo added to **** in Combination

with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin and ****.

A Four–Week, Double–Blind, Placebo–Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of **** in Female Subjects with Interstitial Cystitis /Bladder Pain Syndrome

A Phase IIa, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of **** for Migraine Prophylaxis in Patients with Episodic Migraine Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase IV Study to Evaluate the Effect of **** **** on Long-term Cardiovascular Safety and COPD Exacerbations in Patients with Moderate to Very Severe COPD.

A Phase 3B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial **** Administered Orally For 12 Weeks to Patients with Chronic Constipation and Prominent Abdominal Bloating At Baseline.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of **** in the Treatment of Patients with Irritable Bowel Syndrome with Diarrhea.

A Phase III, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of **** ****/**** **** Compared With **** ****, **** ****and Placebo for 24- Weeks Treatment in Patients with Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD).

A Phase III, Long-Term, Randomized, Double-Blind, Extension Study of the Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of **** ****/**** ****, **** ****, **** **** and Placebo for 28-Weeks Treatment in Patients with Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD).

A 52-Week, Double-Blind, Randomized, Placebo–Controlled, Parallel–Group Study to Evaluate the Effect of **** 500 μg on Exacerbation Rate in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Treated with a Fixed–Dose Combination of Long-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS).

A Long-Term, Randomized, Study of the Safety and Tolerability of a Fixed-Dose Combination of **** ****/**** **** compared with **** **** in Patients with Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD).

A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Study Comparing ***Pharmaceuticals **** Vaginal Tablets With **** (****) Vaginal Tablets (**** ****) in the Treatment of Atrophic Vaginitis.

A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Evaluate the Clinical Equivalence of **** 24mcg Capsules (****Pharmaceuticals, Inc.,) with ****(****) 24 mcgs Capsules (****Pharmaceuticals, Inc).

A Randomized, Double-Blind, Placebo-Controlled, Multi-Site3 Study Comparing **** Topical Gel 1% (**** **** ****). To **** (**** Gel) 1% (**** in the Treatment of Moderate to Severe Rosacea. Phase 3b, Multi-Center, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of **** in Patients with Rheumatoid Arthritis (RA).

A Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of **** in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to **** Therapy.

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of **** in Patients with Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-Rheumatic Drug (DMARD) Therapy (****).

A 52-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of **** *** µg on Exacerbation Rate in Patients with Chronic Obstructive Pulmonary Disease (COPD) Treated with a Fixed-Dose Combination of Long-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS)

A Phase 2B Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose-Ranging Study to Assess the Efficacy, Safety and Tolerability of **** Following monthly and Twice Monthly Subcutaneous Dosing for Six Months in Hypercholesterolemic Subjects on a Statin.

A Randomized, Double-Blind, Placebo-Controlled, Event- Driven Trial of Quarterly Subcutaneous **** in the Prevention of Recurrent Cardiovascular Events Among Stable Post-Myocardial Infarction Patients with Elevated hsCRP.

A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety and Tolerability of **** Following Subcutaneous Dosing For 52 Weeks in Subjects with Primary Hypercholesterolemia Mixed Dyslipidemia, at High and Very High Risk of Cardiovascular Events, Not Controlled with Lipid Lowering Therapy.

A 12-week treatment, multi-center, randomized, double- blind, parallel-group, placebo and active controlled study to assess the efficacy, safety, and tolerability of **** (****/ **** ****) in COPD patients with moderate to severe airflow limitation.

A Phase III, Long-Term, Randomized, Double-Blind, Extension Study of the Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of **** ****/**** ****, **** ****, **** **** and Placebo for 28-Weeks Treatment in Patients with Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD).

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Occurrence of Major Adverse Cardiovascular Events (MACE) in Overweight and Obese Subjects with Cardiovascular Risk Factors Receiving **** **/**** **.

AClinical Outcomes Study to compare the effect of **** ****/**** Inhalation Powder **/**mcg with placebo on Survival in Subjects with moderate Chronic Obstructive Pulmonary Disease (COPD) and a history of or at increased risk for cardiovascular disease.

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of **** in the Treatment of Patients with Diarrhea-Predominant Irritable Bowel Syndrome.

A Randomized, Double-Blind, Placebo- and Active- Controlled Study to Evaluate the Safety and Efficacy of **** in Patients with Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee.

A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design, Study Comparing 1% ****/5% **** **** Topical Gel (**** Pharmaceuticals) to ****® Topical Gel 1% ****/5% **** **** (****) in the Treatment of Acne Vulgaris.

A Study to Assess Repeat Treatment Efficacy and Safety of **** ***mg TID in Subjects with Irritable Bowel Syndrome with Diarrhea (IBS-D).

A Four-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of AF-219 in Female Subjects with Interstitial Cystitis /Bladder Pain Syndrome.

A Four-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of **-*** in Subjects with Osteoarthritis of the Knee.

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When *** *** is Used in Combination with Statin Therapy in Patients with Clinically Evident Cardiovascular Disease.

A Randomized, Placebo-Controlled, Double-Blind Study to evaluate the efficacy and safety of a single * ml intro-articular injection of **** in adults with pain due to Osteoarthritis of the knee.

A Randomized, Long-term, Open-Label, 3-Arm, Multicenter Study to compare the Glycemic effects, safety and tolerability of *** once weekly suspension to *** and Placebo in subjects with type 2 Diabetes Mellitus.

A multi-center, parallel, double-blind, randomized, placebo-controlled study to evaluate the safety and effectiveness of ****, a new **** ****, for the treatment of osteoarthritis of the knee.

A 52-Week, Multi-center, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of **** in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting B2-Agonist (****).

A Randomized, Double-Blind, Double Dummy, Placebo-controlled, Parallel group, Multicenter Phase III Study to evaluate the efficacy and safety of 3 doses of **** (****) in patients with severe to very severe COPD with a history of COPD exacerbations (****).

A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of ***-**** Versus **** in Subjects with Rheumatoid Arthritis and Inadequate Response to Treatment With ****.

A Phase III, 52 weeks, randomized, double-blind, 3-arm parallel group study, comparing the efficacy, safety and tolerability of the fixed dose triple combination **** with the fixed dose dual combinations of **/** and ****/**, all administered once-daily in the morning via a dry powder inhaler in subjects with COPD.

A Randomized, Double-Blind, Placebo Controlled, 2-arm, Parallel-group, 26-week, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of **** in the Treatment of Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on **** and **** Therapy.

A 12-week treatment, multi-center, randomized, double-blind, parallel-group, placebo and active controlled study to assess the efficacy, safety, and tolerability of **** (****/****) in COPD patients with moderate to severe airflow limitation.

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of *** *** in Migraine Prevention.

A Randomized, Double-Blind, Placebo- And Active-Controlled Study of **-**** in Subjects with Pain Associated with Fibromyalgia. A Randomized, Double-Blind, Placebo controlled Safety Study Of **-**** For Treatment of Pain Due to Fibromyalgia in Subjects with Chronic Kidney Disease.

A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ***-*** to Placebo in Subjects with Erosive Hand Osteoarthritis.

A Phase 2a Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ***-*** in Patients with Knee Osteoarthritis.

A Phase 3, Randomized, Double-Blind Study Comparing ***-*** to Placebo and to ********** in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to ***(***-**).

A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled, Dose-ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability Of ********* Delayed-Release in Subjects with Type 2 Diabetes Mellitus.

A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of *********** Administered Orally for 12 Weeks to Patients with Irritable Bowel Syndrome with Constipation (IBS-C).

A Phase 2b, Randomized, Double-blind, Double-dummy, Placebo controlled, Parallel-group, Dose-range-finding Study of Two Delayed Release Formulations of *********** Administered Orally for 12 Weeks to Patients with Irritable Bowel Syndrome with Constipation.

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of ***********(** ug or *** ug) Administered Orally for 12 Weeks to Patients with Chronic Idiopathic Constipation.

A Multicenter Randomized, Double-Blind, Parallel-Group Study Comparing the Efficacy and Safety of ******* Topical Gel, 0.1%, to ****** Gel Comparator in the Management of Painful Diabetic Neuropathy.

A Randomized Withdrawal, Double-blind, Placebo-controlled Phase 3 Trial to Evaluate the Efficacy, Tolerability and Safety of ****** Prolonged-release in Patients with Moderate to Severe Chronic Low Back Pain.

A Randomized, Double-blind, Placebo-controlled, Multicenter Long-term Safety and Tolerability Study of ***** in Patients with Hyperlipidemia at High Cardiovascular Risk Who are not adequately Controlled by Their Lipid-Modifying Therapy.

A Randomized, Double-Blind, Multi-Center, Parallel Group Study to Assess the Efficacy and Safety of ***** Relative to ***** and ***** on COPD Exacerbations over a 52-Week Treatment Period in Subjects with Moderate to Very Severe COPD.

A Randomized, Double-Blind, Parallel–Group, 24–Week, Chronic– Dosing, Multi–Center Study to Assess the Efficacy and Safety of ****, ****, and **** Compared with ********* as an Active Control in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease.

A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of ****, **** and ***** in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease.

A Phase 3, 12-week, Randomized, Double−Blind Placebo−Controlled Parallel Group Study of ******* **** in Subjects with Chronic Obstructive Pulmonary Disease.

Clinical Evaluation of the ****** Herpes Simplex Viruses 1 & 2 Assay on the ******* in Swab Specimens from Symptomatic Subjects Presenting with a Suspected Herpes Lesion(s.)

A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Generic ******** and ******** Inhalation Powder Compared with ********* in Subjects with Asthma.

A 24-week treatment, multicenter, randomized, double blinded, double dummy, parallel-group, clinical trial evaluating the efficacy and safety of **** **** 400 μg/**** **** 12 μg fixed-dose combination BID compared with each monotherapy **** / ****400 μg BID and **** ****12 μg BID) and **** 18 μg QD when administered to patients with stable chronic obstructive pulmonary disease.

An Open Label Long-Term Safety Study of **** for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C).

A 26-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of **** for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C).

A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study with a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of **** for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C).

A Safety and Efficacy Evaluation of **** **** Laxative in Constipated Adults.

A Safety and Efficacy Evaluation of *** *** Laxative in Adults Experiencing Non-Idiopathic Constipation.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy, Tolerability and Safety Study of ***-** in Episodic Migraine with or Without Aura.

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-range-finding Trial of **-**** Administered Orally for 8 Weeks to Patients with Symptomatic Gastroesophageal Reflux Disease Not Completely Responsive to Proton Pump Inhibitors.

A Phase 2b, Randomized, Double-blind, Double-dummy, Placebo- controlled, Parallel-group, Dose-range-finding Study of Two Delayed Release Formulations of **** Administered Orally for 12 Weeks to Patients with Irritable Bowel Syndrome with Constipation.

A 52-week, multicenter, randomized, double-blind, placebo- controlled study to assess the efficacy and safety of ***** when added to existing asthma therapy in patients with uncontrolled severe asthma.

A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of *-***** Compared with Placebo or ***** 75 mg Twice Daily for 5 Days in Patients with Influenza at High Risk of Influenza Complications.

A Randomized, Single-Blind, Parallel-Group, Placebo-Controlled, Multi-dose Study

Comparing the Therapeutic Equivalence of a ** Inhaler and a **** Reference Inhaler, each Delivering ****/**** (80 μg/4.5 μg) in Adult Subjects with Asthma.

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Enriched-Enrollment Withdrawal, Multicenter Study to Evaluate the Efficacy and Safety of a Long-Acting Subcutaneous Injectable Depot of **** (****) in Subjects with Moderate to Severe Chronic Low Back Pain Currently Treated with Daily Opioids.

A 6-week, randomized, double-blind, placebo and active-controlled, parallel group, dose ranging study to evaluate the efficacy and safety of 4 doses of *** **** pMDI (**** ****) in subjects with Chronic Obstructive Pulmonary Disease (COPD).

A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of **** Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate.

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of **** Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment.

A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of **** Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy.

A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of **** in Subjects with Rheumatoid Arthritis.

A Phase 3, Randomized, Double-Blind Study Comparing **** Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX.

A Phase 4 Multicenter, Multinational, Prospective, Randomized, Placebo• Controlled, Double-Blinded Parallel Group Study to Assess Efficacy of **** in the Treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D) in Patients Who Report Inadequate Control of IBS-D Symptoms with Prior **** Use (RELIEF).

A Randomized, Double-blind, Placebo-controlled, Phase 2b Study to Assess the Efficacy and Safety of Orally Administered **** in Patients with Moderate to Severe Atopic Dermatitis.

A Randomized, Double-blind, Placebo-Controlled, Multi-center Long-term Safety and Tolerability Study of *** **** in Patients with Hyperlipidemia at High Cardiovascular risk who are not adequately controlled by their lipid-modifying therapy.

A Multicenter Open-label Extension (OLE) Study to Assess the Long-Term Safety and efficacy of **** **** (****) 180 mg.

A 24-week treatment, multi-center, randomized, double-blind, double-dummy, parallel group study to compare ****/****, ****, and ****in subjects with chronic obstructive pulmonary disease (COPD).

A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double-Blind, 12-Week Study With a 40-Week, Active-Controlled, Double-Blind Extension to Evaluate the Efficacy and Safety of **** in Adult Patients with Fasting Triglyceride Levels ³500 mg/dL and

<2000 mg/dL and Normal Renal Function.

A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double-blind, 12-Week Study With a 40-Week, Active-Controlled, Open-Label Extension to Evaluate the Efficacy and Safety of **** in Adult Patients with Fasting Triglyceride Levels ³500 mg/dL and

<2000 mg/dL and Mild or Moderate Renal Impairment.

A Randomized, Double-blind, Placebo-controlled, Event- driven trial of quarterly subcutaneous **** in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP.

A 52-week, Multicenter, Randomized, Double-blind, Placebo controlled Study to assess the efficacy and safety of ***** when added to existing asthma therapy in patients with uncontrolled severe asthma.

A Phase 2, 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of **** for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis.

A Phase 3b, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Study to Compare Once Daily Nebulized **** with **** Once Daily Delivered via the **** on Lung Function in Subjects with Chronic Obstructive Pulmonary Disease and a Low Peak Inspiratory Flow Rate.

A prospective, multicenter, randomized, double-blind, Sham- controlled study to assess the efficacy and safety of the **** capsule administered 5 times per week.

A Phase 2 Open-Label Study of ****** in the treatment of Edematous Fibrosclerotic Panniculopathy.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Randomized, Double-Blind Study of ****** in the Treatment of Edematous Fibrosclerotic Panniculopathy.

A Phase 3B, Open-Label, Long-Term Study to evaluate the safety and Temporal Pattern of Response of ******** in the Treatment of Edematous Fibrosclerotic Panniculopathy.

A Phase 2 Randomised, Double Blind, Placebo-Controlled, Parallel Group, Multicentre Study to Evaluate the Safety and Efficacy of Repeated Oral Doses of **** in Adult Subjects with Irritable Bowel Syndrome (IBS) Subtypes IBS-C and IBS-D.

Testosterone Replacement therapy for Assessment of long-term Vascular Events and efficacy Response in hypo-gonadal men (****) Study.

A Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized, Phase II Study of **** Delivered as a Topical Spray to Determine Safety in Subjects with Mild to Moderate Atopic Dermatitis.

A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of ***-***** in Subjects with Moderate-to-Severe Plaque Psoriasis.

Efficacy and safety of 3 doses of *****/***** administered orally once daily in patients with knee osteoarthritis. A 52-week international, multi-regional, multi-center, randomized, double-blind, placebo- controlled, dose-ranging study, ***** Study.

A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of ***** Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate.

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of ***** Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment.

A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of ***** Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy.

A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of ****** in Subjects with Rheumatoid Arthritis.

A Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of **** 290 µg Administered Orally for 12 Weeks Followed by a 4-week Randomized Withdrawal Period in Patients with Irritable Bowel Syndrome with Constipation.

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral **-**** Administered to Patients with Gastroesophageal Reflux Disease while receiving Proton Pump Inhibitors.

A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of **** 200 mg in Combination with a Xanthine Oxidase Inhibitor (XOI), Compared with an XOI Alone, in Subjects with Gout and Estimated Creatinine Clearance 30 to < 60 mL/min Who Have Not Achieved Target Serum Uric Acid Levels on an XOI Alone.

A Multi-Center, Randomized, Double-blind, Placebo-controlled, Multi-Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of ***-**** with Expanded Dose Finding in Subjects with Moderate-to-severe Plaque Psoriasis.

A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of ** ***** Gel in Subjects with Persistently Active Systemic Lupus Erythematosus Despite Moderate Dose Corticosteroids.

A Randomized, Double-Blind, Parallel Group, Multi-Center 24-Week Study Comparing the Efficacy and Safety of Three Doses of ***** to Placebo and Open-label ***** ***** in Subjects with Persistent Asthma.

A Phase 3, Multicenter, Observational Long-term Study Evaluating the Safety, Tolerability, and Efficacy of Treatment of ****** or Placebo Previously Injected in the Target Knee Joint of Subjects with Moderately to Severely Symptomatic Osteoarthritis.

A Phase 2, 52-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Two Injections of ****** Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects.

A Long-Term, Open-Label Study to Evaluate the Safety of **** (****** Intracutaneous Microneedle System) in the Acute Treatment of Migraine.

A 52-week, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of ***** when added to existing asthma therapy in patients with uncontrolled severe asthma.

A 6-week, randomized, double-blind, placebo and active-controlled, parallel group, dose ranging study to evaluate the efficacy and safety of 4 doses of *** **** (***** *****) in subjects with Chronic Obstructive Pulmonary Disease (COPD).

A 24-week treatment, multi-center, randomized, double-blind, double-dummy, parallel group study to compare ****/****, ****, and **** in subjects with chronic obstructive pulmonary disease (COPD).

A randomized, double-blind, parallel group, multicenter, stratified study evaluating the efficacy and safety of repeat doses of ***** compared with placebo in participants with moderately severe asthma.

A Multi-center, Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of ***** in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma.

A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Generic **** **** 100 μg and **** **** 50 μg Inhalation Powder Compared with **** 100/50 in Subjects with Asthma.

A Randomized, Single-Blind, Parallel-Group, Placebo-Controlled, Multi-dose Study Comparing the Therapeutic Equivalence of a ** Inhaler and a ***** Reference Inhaler, Each Delivering ****/**** **** (80 μg/4.5 μg) in Adult Subjects with Asthma.

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of ***** as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis.

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of ***** as Maintenance Therapy in Subjects with Moderate to Severe Ulcerative Colitis.

A Phase 3 Long-term Safety Extension Study of ***** in Subjects with Moderate to Severe Ulcerative Colitis or pMDI Disease (AIDA).

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of ***** as Induction Therapy in Subjects with Moderate to Severe Crohn’s Disease.

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of ***** as Maintenance Therapy in Subjects with Moderate to Severe Crohn’s Disease.

A Study to Support the Radiographic Eligibility Screening Process of ****** Studies in Symptomatic Knee Osteoarthritis Subjects.

A Phase 3, 28-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of ***-****** Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects.

A Phase II, Randomized, Double-Blind, Vehicle Controlled Study of the Efficacy, Safety, and Tolerability of **** Topical Spray for the Treatment of Pruritus in Adults with a History of Atopic Dermatitis.

A Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized, Phase II Study of **** Delivered as a Topical Spray to Determine Safety in Subjects with Mild to Moderate Atopic Dermatitis.

A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of ******* Therapy in Patients with Clinically Evident Cardiovascular Disease.

A Randomized Double-blind Placebo Controlled Phase 3 Trial to evaluate the Efficacy and Safety of **** for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (**Comfort Study II).

A Phase 3, Randomized, Placebo-controlled, 12-week Double-blind Study, followed by a Non-Controlled Extension Treatment Period, to Assess the Efficacy and Safety of ******** in Women Suffering from Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated with Menopause.

A Randomized, Placebo-Controlled, Double-Blind Phase 3 Clinical Study to Investigate the Long-Term Safety of ******** in Women Suffering from Vasomotor Symptoms (Hot Flashes) Associated with Menopause.

A Randomized, Blinded, Parallel Group, Placebo- Controlled, Multiple Dose, Multicenter Study to Compare the Therapeutic Equivalence of **** **** Pressurized Metered Dose Inhaler, **** mcg, to ****® HFA *** mcg, in Adult Subjects with Asthma.

A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Single Doses of ******* (****** Nasal Powder) in the Acute Treatment of Migraine.

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral **-**** Administered to Patients with Gastroesophageal Reflux Disease while receiving Proton Pump Inhibitors.

A Phase 3, Double-Blind, Randomized, 8-Week, Vehicle-Controlled Efficacy and Safety Study of ****** Cream Followed by a Long-Term Safety Extension Period in Adolescents and Adults with Atopic Dermatitis.

A Double-Blind, Placebo-Controlled, Phase 2, Responsive Adaptive Randomization Study of ***-*** in Patients with Irritable Bowel Syndrome with Diarrhea (IBS-D).

A randomized, double-blind, placebo-controlled study to assess the impact of a **** and **** containing dietary supplement, **** ****® **** ****** Advanced with **** & ****, on knee joint health and comfort.

A Phase 3, Randomized, Double-Blind Study Comparing ***-*** Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX.

A Phase 3 Randomized Multicenter Study to Evaluate the Efficacy and Safety of Open-Label Dual Therapy with Oral ***** 20 mg or Double-Blind Triple Therapy with Oral ***** 20 mg Compared to Double-Blind Triple Therapy with Oral ********* 30 mg Daily in Patients with Helicobacter Pylori Infection.

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of ****** as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC ***).

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of ****** as Maintenance Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC ***).

A Phase 3 Long-term Safety Extension Study of ****** in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA).

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Crohn’s Disease (CARMEN CD ***).

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of ****** as Maintenance Therapy in Subjects with Moderate to Severe Crohn’s Disease (CARMEN CD ***) Testosterone Replacement therapy for Assessment of long-term Vascular Events and efficacy Response in hypogonadal men (TRAVERSE) Study.

A Phase 3, 28-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of *** ******Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects.

A Study to Support the Radiographic Eligibility Screening Process of ******* Studies in Symptomatic Knee Osteoarthritis Subjects.

A Phase II, Randomized, Double-Blind, Vehicle Controlled Study of the Efficacy, Safety, and Tolerability of ****Topical Spray for the Treatment of Pruritus in Adults with a History of Atopic Dermatitis.

A Phase 3, Randomized, Placebo-controlled, 12-week Double-blind Study, followed by a Non-Controlled Extension Treatment Period, to Assess the Efficacy and Safety of ****** in Women Suffering from Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated with Menopause.

A Randomized, Placebo-Controlled, Double-Blind Phase 3 Clinical Study to Investigate the Long-Term Safety of *****in Women Suffering from Vasomotor Symptoms (Hot Flashes) Associated with Menopause.

A Randomized Double-blind Placebo Controlled Phase 3 Trial to evaluate the Efficacy and Safety of ***** for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study II).

A multi-center, randomized, double-blind, parallel-group, placebo- controlled study of ******** *** mg SC as add-on treatment in participants with COPD experiencing frequent exacerbations and characterized by eosinophil levels.

A Phase 3, Double-Blind, Randomized, 8-Week, Vehicle-Controlled Efficacy and Safety Study of ***** Cream Followed by a Long-Term Safety Extension Period in Adolescents and Adults with Atopic Dermatitis.

A Double-Blind, Placebo-Controlled, Phase 2, Responsive Adaptive Randomization Study of ***-*** in Patients with Irritable Bowel Syndrome with Diarrhea (IBS-D).

A Phase 3, Randomized, Double-Blind, Two-Phase, Multicenter Study to Evaluate the Efficacy and Safety of ***** ** mg Compared to ***** ** mg for Healing in Patients with Erosive Esophagitis and to Evaluate the Efficacy and Safety of ***** (** mg and ** mg) Compared to ****** ** mg for the Maintenance of Healing in Patients with Healed Erosive Esophagitis.

A Phase 3 Randomized Multicenter Study to Evaluate the Efficacy and Safety of Open-Label Dual Therapy with Oral ***** ** mg or Double-Blind Triple Therapy with Oral ****** ** mg Compared to Double-Blind Triple Therapy with Oral ****** **mg Daily in Patients with Helicobacter Pylori Infection.

A Phase 3, 28-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of ******* Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects.

A Study to Support the Radiographic Eligibility Screening Process of Samumed Studies in Symptomatic Knee Osteoarthritis Subjects.

A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Single Doses of ******* (***** Nasal Powder) in the Acute Treatment of Migraine.

A Randomized, Blinded, Parallel Group, Placebo- Controlled, Multiple Dose, Multicenter Study to Compare the Therapeutic Equivalence of ***** **** Pressurized Metered Dose Inhaler, *** mcg, to ****® HFA 110 mcg, in Adult Subjects with Asthma.

A phase III, 52-week, multinational, multicenter, randomized, double-blind, 2-arm parallel group study comparing efficacy, safety and tolerability of the fixed dose triple combination of ***** / ****** plus ***** / ***** plus ***** *****(*** ****) with the fixed dose dual combination of beclomethasone dipropionate plus formoterol fumarate (*** ****), both administered via pMDI in subjects with chronic obstructive pulmonary disease (COPD).