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A Comparison of Once a Day Dose Compared to 2 Doses/Day

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Mesalamine Once-Daily
Mesalamine Twice-Daily
Sponsored by
Warner Chilcott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Documented history of ulcerative colitis that has been successfully maintained in remission for at least 3 months prior to study entry
  • At least one flare in the past 18 months
  • Utilizing a stable maintenance dose of oral Asacol of 1.6 g/day up to 2.4 g/day (stable dose is defined as the same dose for the past 3 months)
  • Females must be postmenopausal or surgically sterile or have a negative urine pregnancy test and practice acceptable contraception

Exclusion Criteria:

  • History of or current renal disease
  • History of hepatic disease
  • History of allergy or hypersensitivity to salicylates, aminosalicylates
  • Treatment with immunomodulatory therapy, biologic therapy or corticosteroids within 90 days of screening
  • Received any antidiarrheals, antispasmodics, or antibiotic within 1 month of screening

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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mesalamine (Asacol) Once-Daily

Mesalamine (Asacol) Twice-Daily

Arm Description

an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)

an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)

Outcomes

Primary Outcome Measures

Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI)
Remission defined as SCCAI <5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).

Secondary Outcome Measures

Percentage of Patients Remaining in Remission at Month 3, ITT Population
Remission defined as SCCAI < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).
Percentage of Patients Remaining in Remission at Month 12, ITT Population
Remission defined as SCCAI score < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).
Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population
Relapse/flare is defined as SCCAI >= 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).
Total MARS (Medication Adherence Report Scale) Questionnaire Scores, ITT Population, Month 6
MARS: Composite score for the following statements: I change how many times per day I take my medicine, I forget to use it, I stop taking it for a while, I only use it when I am having active symptoms, I decide to miss out on a dose, I take less than instructed, I take more than instructed, I avoid using it if I can, I use it regularly every day (reverse scored): 5-never, 4-rarely, 3-sometimes, 2-often, 1-very often. Minimum score 9, maximum score 45.
Percentage of Participants Indicating Ulcerative Colitis in Remission (Patient Defined Remission Index), ITT Population, Month 6
Is your ulcerative colitis in remission (not active)? Y/N

Full Information

First Posted
July 20, 2007
Last Updated
April 15, 2013
Sponsor
Warner Chilcott
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1. Study Identification

Unique Protocol Identification Number
NCT00505778
Brief Title
A Comparison of Once a Day Dose Compared to 2 Doses/Day
Official Title
A Multi-center, Investigator-blinded, Randomized, 12-month, Parallel-group, Non-inferiority Study to Compare the Efficacy of 1.6 to 2.4 g Asacol® Therapy QD Versus Divided Dose (BID) in the Maintenance of Remission of Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy in maintaining remission of ulcerative colitis between a once daily (QD) Asacol regimen and a divided, twice daily (BID) Asacol dosing regimen.
Detailed Description
Currently, in the US, Asacol therapy is indicated in divided doses for the maintenance of remission of ulcerative colitis at 1.6 g/day. A once daily dose is potentially beneficial to patients and physicians alike. This study will answer the following questions about once daily dosing: (1) does efficacy differ between once daily and twice daily dosing, (2) do patients prefer a once daily dosing regimen, and (3) is compliance better? This study will confirm whether there are benefits to once daily dosing beyond increased convenience. In order to understand how the QD regimen compares to BID in a "real life" practice setting, the patient will remain on the total daily dose of Asacol (1.6 g/day to 2.4 g/day) on which they were maintained in remission, but will be assigned to either a QD or BID regimen. This is an investigator-blinded study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1027 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesalamine (Asacol) Once-Daily
Arm Type
Active Comparator
Arm Description
an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
Arm Title
Mesalamine (Asacol) Twice-Daily
Arm Type
Active Comparator
Arm Description
an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
Intervention Type
Drug
Intervention Name(s)
Mesalamine Once-Daily
Other Intervention Name(s)
Asacol QD
Intervention Description
Mesalamine tablets, 1.6-2.4 g/day taken orally once a day for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Mesalamine Twice-Daily
Other Intervention Name(s)
Asacol BID
Intervention Description
Mesalamine tablets, 1.6-2.4 g/day, taken twice daily for 52 weeks
Primary Outcome Measure Information:
Title
Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI)
Description
Remission defined as SCCAI <5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of Patients Remaining in Remission at Month 3, ITT Population
Description
Remission defined as SCCAI < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).
Time Frame
3 months
Title
Percentage of Patients Remaining in Remission at Month 12, ITT Population
Description
Remission defined as SCCAI score < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).
Time Frame
12 months
Title
Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population
Description
Relapse/flare is defined as SCCAI >= 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).
Time Frame
6 months
Title
Total MARS (Medication Adherence Report Scale) Questionnaire Scores, ITT Population, Month 6
Description
MARS: Composite score for the following statements: I change how many times per day I take my medicine, I forget to use it, I stop taking it for a while, I only use it when I am having active symptoms, I decide to miss out on a dose, I take less than instructed, I take more than instructed, I avoid using it if I can, I use it regularly every day (reverse scored): 5-never, 4-rarely, 3-sometimes, 2-often, 1-very often. Minimum score 9, maximum score 45.
Time Frame
6 months
Title
Percentage of Participants Indicating Ulcerative Colitis in Remission (Patient Defined Remission Index), ITT Population, Month 6
Description
Is your ulcerative colitis in remission (not active)? Y/N
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented history of ulcerative colitis that has been successfully maintained in remission for at least 3 months prior to study entry At least one flare in the past 18 months Utilizing a stable maintenance dose of oral Asacol of 1.6 g/day up to 2.4 g/day (stable dose is defined as the same dose for the past 3 months) Females must be postmenopausal or surgically sterile or have a negative urine pregnancy test and practice acceptable contraception Exclusion Criteria: History of or current renal disease History of hepatic disease History of allergy or hypersensitivity to salicylates, aminosalicylates Treatment with immunomodulatory therapy, biologic therapy or corticosteroids within 90 days of screening Received any antidiarrheals, antispasmodics, or antibiotic within 1 month of screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom G Todaro, MD
Organizational Affiliation
Procter and Gamble
Official's Role
Study Director
Facility Information:
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City
Athens
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Alabama
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35611
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United States
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Birmingham
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Alabama
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35209
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United States
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Birmingham
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Alabama
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35294
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United States
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Dothan
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Alabama
ZIP/Postal Code
26305-1156
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United States
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Phoenix
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Arizona
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85050
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United States
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Scottsdale
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Arizona
ZIP/Postal Code
85259
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United States
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Tucson
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Arizona
ZIP/Postal Code
85712
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United States
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Tuscon
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Arizona
ZIP/Postal Code
85711
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United States
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Little Rock
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Arkansas
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72205
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United States
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Lowell
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Arkansas
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72745
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United States
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Anaheim
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California
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92801
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United States
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Beverly Hills
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California
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90210
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United States
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Chico
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California
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95926
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United States
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Encinitas
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California
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92024
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United States
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Folsum
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California
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95630
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United States
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La Mesa
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California
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91941
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United States
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Lancaster
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California
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93534
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United States
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Long Beach
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California
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90806
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Los Angeles
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California
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90015
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United States
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Los Angeles
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California
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90045
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United States
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Madera
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California
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93637
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United States
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Merced
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California
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95340
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United States
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Mission Hills
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California
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91345
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United States
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Monterey
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California
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93940
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United States
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Murrieta
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California
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92562
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United States
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Oakland
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California
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94609
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United States
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Orange
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California
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92868
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United States
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Palm Springs
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California
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92262
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United States
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San Carlos
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California
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94070
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United States
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San Diego
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California
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92103
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United States
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San Diego
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California
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92117
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United States
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San Diego
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California
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92123
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United States
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San Francisco
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California
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94117
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United States
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San Francisco
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California
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94122
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Torrance
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California
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90503
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Torrance
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California
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90505
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Upland
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California
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91786
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Englewood
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Colorado
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80113
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United States
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Golden
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Colorado
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80401
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United States
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Lafayette
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Colorado
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80026
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United States
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Pueblo
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Colorado
ZIP/Postal Code
81008
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United States
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Hartford
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Connecticut
ZIP/Postal Code
06106
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United States
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Meriden
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Connecticut
ZIP/Postal Code
06451
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United States
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New Haven
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Connecticut
ZIP/Postal Code
06510
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United States
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Norwalk
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Connecticut
ZIP/Postal Code
06851
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United States
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Torrington
State/Province
Connecticut
ZIP/Postal Code
06790
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United States
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Washington
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District of Columbia
ZIP/Postal Code
20060
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United States
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Aventura
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Florida
ZIP/Postal Code
33180
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United States
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Fort Lauderdale
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Florida
ZIP/Postal Code
33308
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United States
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Gainesville
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Florida
ZIP/Postal Code
32607
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United States
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Hollywood
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Florida
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33021
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United States
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Jacksonville
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Florida
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32207
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United States
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Jacksonville
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Florida
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32223
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United States
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Largo
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Florida
ZIP/Postal Code
33777
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United States
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Maitland
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Florida
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32751
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United States
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Research Facility
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Naples
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Florida
ZIP/Postal Code
34102
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United States
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New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
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United States
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Research Facility
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North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
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United States
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Research Facility
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Orlando
State/Province
Florida
ZIP/Postal Code
32806
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United States
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Research Facility
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
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United States
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Research Facility
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Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
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Research Facility
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St Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Facility Name
Research Facility
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Facility Name
Research Facility
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Research Facility
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Research Facility
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Research Facility
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Research Facility
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
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United States
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Research Facility
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
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United States
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Research Facility
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Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-5000
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United States
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Research Facility
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Columbus
State/Province
Georgia
ZIP/Postal Code
31904
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United States
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Research Facility
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Decatur
State/Province
Georgia
ZIP/Postal Code
30033
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United States
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Research Facility
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Marietta
State/Province
Georgia
ZIP/Postal Code
30060
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United States
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Research Facility
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Marietta
State/Province
Georgia
ZIP/Postal Code
30067
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United States
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Research Facility
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Newnan
State/Province
Georgia
ZIP/Postal Code
30263
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United States
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Research Facility
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
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United States
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Research Facility
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Research Facility
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Research Facility
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Research Facility
City
Berwyn
State/Province
Illinois
ZIP/Postal Code
60402
Country
United States
Facility Name
Research Facility
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Research Facility
City
Elgin
State/Province
Illinois
ZIP/Postal Code
60123
Country
United States
Facility Name
Research Facility
City
Highland Park
State/Province
Illinois
ZIP/Postal Code
60036
Country
United States
Facility Name
Research Facility
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Research Facility
City
Homewood
State/Province
Illinois
ZIP/Postal Code
60430
Country
United States
Facility Name
Research Facility
City
Lake Barrington
State/Province
Illinois
ZIP/Postal Code
60010
Country
United States
Facility Name
Research Facility
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Research Facility
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Research Facility
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Research Facility
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46016
Country
United States
Facility Name
Research Facility
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47403
Country
United States
Facility Name
Research Facility
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Research Facility
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Research Facility
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Research Facility
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Research Facility
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52807
Country
United States
Facility Name
Research Facility
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50701
Country
United States
Facility Name
Research Facility
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Research Facility
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Research Site
City
Whichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Research Facility
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Research Facility
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Research Facility
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Facility Name
Research Facility
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Research Facility
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Research Facility
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Research Facility
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Research Facility
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Research Facility
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Research Facility
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Research Facility
City
College Park
State/Province
Maryland
ZIP/Postal Code
20740
Country
United States
Facility Name
Research Facility
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
Facility Name
Research Facility
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Research Facility
City
Hollywood
State/Province
Maryland
ZIP/Postal Code
20636
Country
United States
Facility Name
Research Facility
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Research Facility
City
Reisterstown
State/Province
Maryland
ZIP/Postal Code
21136
Country
United States
Facility Name
Research Facility
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Research Facility
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20854
Country
United States
Facility Name
Research Facility
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Research Facility
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Research Facility
City
Braintree
State/Province
Massachusetts
ZIP/Postal Code
02184
Country
United States
Facility Name
Research Facility
City
Southbridge
State/Province
Massachusetts
ZIP/Postal Code
01550
Country
United States
Facility Name
Research Facility
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Research Facility
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Research Facility
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Research Facility
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Research Facility
City
West Bloomfied
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Research Facility
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Research Facility
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Research Facility
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Research Facility
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703-6364
Country
United States
Facility Name
Research Facility
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Research Facility
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Research Facility
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
Research Facility
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Research Facility
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89147
Country
United States
Facility Name
Research Facility
City
Somersworth
State/Province
New Hampshire
ZIP/Postal Code
03878
Country
United States
Facility Name
Research Facility
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Research Facility
City
Cedar Knolls
State/Province
New Jersey
ZIP/Postal Code
07927
Country
United States
Facility Name
Research Facility
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234-5857
Country
United States
Facility Name
Research Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Research Facility
City
Ocean
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Research Facility
City
South Plainfield
State/Province
New Jersey
ZIP/Postal Code
07080
Country
United States
Facility Name
Research Facility
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Research Facility
City
Babylon
State/Province
New York
ZIP/Postal Code
11702
Country
United States
Facility Name
Research Facility
City
Binghamton
State/Province
New York
ZIP/Postal Code
13903
Country
United States
Facility Name
Research Facility
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Research Facility
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11234
Country
United States
Facility Name
Research Facility
City
Cheektowaga
State/Province
New York
ZIP/Postal Code
14225
Country
United States
Facility Name
Research Facility
City
Cortland
State/Province
New York
ZIP/Postal Code
13045
Country
United States
Facility Name
Research Facility
City
Forest Hills
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Research Facility
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Research Facility
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Research Facility
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Research Facility
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Research Facility
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Research Facility
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Facility Name
Research Facility
City
Pittsford
State/Province
New York
ZIP/Postal Code
14534
Country
United States
Facility Name
Research Facility
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Facility Name
Research Facility
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
Research Facility
City
Rochester
State/Province
New York
ZIP/Postal Code
14625
Country
United States
Facility Name
Research Facility
City
Boone
State/Province
North Carolina
ZIP/Postal Code
28607
Country
United States
Facility Name
Research Facility
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Research Facility
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Research Facility
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Research Facility
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
Facility Name
Research Facility
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Research Facility
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
Research Facility
City
Mt Airy
State/Province
North Carolina
ZIP/Postal Code
27030
Country
United States
Facility Name
Research Facility
City
Newbern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Research Facility
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
Research Facility
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Research Facility
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Research Facility
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Research Facility
City
Akron
State/Province
Ohio
ZIP/Postal Code
44302
Country
United States
Facility Name
Research Facility
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Research Facility
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Research Facility
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Research Facility
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Research Facility
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Research Facility
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45440
Country
United States
Facility Name
Research Facility
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Research Facility
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Facility Name
Research Facility
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
Research Facility
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Research Facility
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Research Facility
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Research Facility
City
Beaver Falls
State/Province
Pennsylvania
ZIP/Postal Code
15010
Country
United States
Facility Name
Research Facility
City
Clairton
State/Province
Pennsylvania
ZIP/Postal Code
15025
Country
United States
Facility Name
Research Facility
City
Indiana
State/Province
Pennsylvania
ZIP/Postal Code
15701
Country
United States
Facility Name
Research Facility
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Research Facility
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Research Facility
City
Phoenixville
State/Province
Pennsylvania
ZIP/Postal Code
19460
Country
United States
Facility Name
Research Facility
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Research Facility
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Research Facility
City
Sewickley
State/Province
Pennsylvania
ZIP/Postal Code
15143
Country
United States
Facility Name
Research Facility
City
Souderton
State/Province
Pennsylvania
ZIP/Postal Code
18964
Country
United States
Facility Name
Research Facility
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Research Facility
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Facility Name
Research Facility
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Research Facility
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Research Facility
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Research Facility
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
Research Facility
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Research Facility
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Research Facility
City
Morristown
State/Province
Tennessee
ZIP/Postal Code
37814
Country
United States
Facility Name
Research Facility
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79119
Country
United States
Facility Name
Research Facility
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Research Facility
City
Greenville
State/Province
Texas
ZIP/Postal Code
75401
Country
United States
Facility Name
Research Facility
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Research Facility
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Research Facility
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Research Facility
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75057
Country
United States
Facility Name
Research Facility
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Research Facility
City
Odessa
State/Province
Texas
ZIP/Postal Code
79761
Country
United States
Facility Name
Research Facility
City
Pasadena
State/Province
Texas
ZIP/Postal Code
77504
Country
United States
Facility Name
Research Facility
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Research Facility
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Facility
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Research Facility
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Research Facility
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84120
Country
United States
Facility Name
Research Facility
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22306
Country
United States
Facility Name
Research Facility
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Research Facility
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Research Facility
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Research Facility
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Research Facility
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Research Facility
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
Research Facility
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Research Facility
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Research Facility
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Research Facility
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Research Facility
City
Monroe
State/Province
Wisconsin
ZIP/Postal Code
53566
Country
United States
Facility Name
Research Facility
City
Abbotsford
State/Province
British Columbia
ZIP/Postal Code
V2S 3N5
Country
Canada
Facility Name
Research Facility
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1H 3R3
Country
Canada
Facility Name
Research Facility
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Research Facility
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Research Facility
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Research Facility
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2O4
Country
Canada
Facility Name
Research Facility
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Research Facility
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Research Facility
City
Quebec
ZIP/Postal Code
G1L 3L5
Country
Canada
Facility Name
Research Facility
City
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Research Facility
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
Research Facility
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
20064514
Citation
Sandborn WJ, Korzenik J, Lashner B, Leighton JA, Mahadevan U, Marion JF, Safdi M, Sninsky CA, Patel RM, Friedenberg KA, Dunnmon P, Ramsey D, Kane S. Once-daily dosing of delayed-release oral mesalamine (400-mg tablet) is as effective as twice-daily dosing for maintenance of remission of ulcerative colitis. Gastroenterology. 2010 Apr;138(4):1286-96, 1296.e1-3. doi: 10.1053/j.gastro.2009.12.054. Epub 2010 Jan 11.
Results Reference
derived

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A Comparison of Once a Day Dose Compared to 2 Doses/Day

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