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PainPhase 3NCT00636064

A Study Comparing the Efficacy and Safety of Valdecoxib Plus Parecoxib Versus Valdecoxib Plus Placebo for the Treatment of Pain After Coronary Artery Bypass Surgery

A Phase 3 study testing Parecoxib Sodium/Valdecoxib in people with Pain, run by Pfizer at 206 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of parecoxib/valdecoxib therapy and placebo/valdecoxib therapy for the treatment of pain after coronary artery bypass surgery Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pain
What is being tested?
Parecoxib Sodium/Valdecoxib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,671 participants
Where
206 sitesin 27 countries
Study dates
Jan 2003to Jan 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients expected to receive in-hospital pain medication for pain after coronary artery bypass graft surgery for at least 3 full days and pain medication over a 10-day period
  • New York Heart Association Class I to III or cardiac ejection fraction of at least 35% before surgery
  • Body mass index of less than or equal to 40 kg/m2 and weight of >55 kg
  • Patients scheduled to undergo an isolated (bypass grafting only without valve replacement, significant aortic reconstruction, or ventriculoplasty) primary CABG surgery via median sternotomy, using cardiopulmonary bypass

Who cannot join

  • Patient has undergone or is going to have emergency coronary artery bypass graft surgery or surgery without cardiopulmonary bypass procedure
  • Symptomatic peripheral vascular disease
  • Heart attack within 48 hours of surgery

Trial locations and contacts

206 sites in 27 countries.

206 sites in 27 countries

United States84 sites
  • Pfizer Investigational Site

    Altoona, Pennsylvania, 16601

  • Pfizer Investigational Site

    Amarillo, Texas, 79106

  • Pfizer Investigational Site

    Anaheim, California, 92801

  • Pfizer Investigational Site

    Anaheim, California, 92805

  • Pfizer Investigational Site

    Annandale, Virginia, 22003

  • Pfizer Investigational Site

    Atlanta, Georgia, 30322

  • Pfizer Investigational Site

    Augusta, Georgia, 30901

  • Pfizer Investigational Site

    Baltimore, Maryland, 21215

  • Pfizer Investigational Site

    Boston, Massachusetts, 02215

  • Pfizer Investigational Site

    Brandon, Florida, 33511

  • Pfizer Investigational Site

    Burlington, Vermont, 05401

  • Pfizer Investigational Site

    Cambridge, Massachusetts, 02138

  • Pfizer Investigational Site

    Charleston, South Carolina, 29401

  • Pfizer Investigational Site

    Charleston, South Carolina, 29406

  • Pfizer Investigational Site

    Charleston, South Carolina, 29424

  • Pfizer Investigational Site

    Charleston, South Carolina, 29425

  • Pfizer Investigational Site

    Cincinnati, Ohio, 45219

  • Pfizer Investigational Site

    Cincinnati, Ohio, 45236

  • Pfizer Investigational Site

    Clearwater, Florida, 33756

  • Pfizer Investigational Site

    Dayton, Ohio, 45408

  • Pfizer Investigational Site

    Dayton, Ohio, 45414

  • Pfizer Investigational Site

    Detroit, Michigan, 48202

  • Pfizer Investigational Site

    Elkhorn, Wisconsin, 53121

  • Pfizer Investigational Site

    Fairhope, Alabama, 36532

  • Pfizer Investigational Site

    Falls Church, Virginia, 22042

  • Pfizer Investigational Site

    Fayetteville, Arkansas, 72703

  • Pfizer Investigational Site

    Fort Collins, Colorado, 80524

  • Pfizer Investigational Site

    Fort Collins, Colorado, 80528

  • Pfizer Investigational Site

    Fort Wayne, Indiana, 46804

  • Pfizer Investigational Site

    Fort Worth, Texas, 76107-2699

  • Pfizer Investigational Site

    Fort Worth, Texas, 76107

  • Pfizer Investigational Site

    Fredericksburg, Virginia, 22401

  • Pfizer Investigational Site

    Houston, Texas, 77030

  • Pfizer Investigational Site

    Hudson, Florida, 34667

  • Pfizer Investigational Site

    Iowa City, Iowa, 52242

  • Pfizer Investigational Site

    Irving, Texas, 75061

  • Pfizer Investigational Site

    Jacksonville, Florida, 32216

  • Pfizer Investigational Site

    Kansas City, Kansas, 66160

  • Pfizer Investigational Site

    Livonia, Michigan, 48150

  • Pfizer Investigational Site

    Los Angeles, California, 90033

  • Pfizer Investigational Site

    Los Angeles, California, 90095-1778

  • Pfizer Investigational Site

    Madison, Wisconsin, 53792

  • Pfizer Investigational Site

    Melbourne, Florida, 32901-3276

  • Pfizer Investigational Site

    Melbourne, Florida, 32901

  • Pfizer Investigational Site

    Memphis, Tennessee, 38120

  • Pfizer Investigational Site

    Milwaukee, Wisconsin, 53215

  • Pfizer Investigational Site

    Mobile, Alabama, 36602

  • Pfizer Investigational Site

    Mobile, Alabama, 36604

  • Pfizer Investigational Site

    Mobile, Alabama, 36607

  • Pfizer Investigational Site

    Mobile, Alabama, 36608

  • Pfizer Investigational Site

    Muskegon, Michigan, 49444

  • Pfizer Investigational Site

    New Haven, Connecticut, 06504

  • Pfizer Investigational Site

    New Haven, Connecticut, 06520

  • Pfizer Investigational Site

    New York, New York, 10029

  • Pfizer Investigational Site

    Norfolk, Virginia, 23507

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73112

  • Pfizer Investigational Site

    Orange, California, 92868

  • Pfizer Investigational Site

    Pensacola, Florida, 32504

  • Pfizer Investigational Site

    Pensacola, Florida, 32514

  • Pfizer Investigational Site

    Pittsburgh, Pennsylvania, 15212

  • Pfizer Investigational Site

    Pittsburgh, Pennsylvania, 15224

  • Pfizer Investigational Site

    Portland, Oregon, 97210

  • Pfizer Investigational Site

    Rochester, New York, 14621

  • Pfizer Investigational Site

    Royal Oak, Michigan, 48073

  • Pfizer Investigational Site

    Sacramento, California, 95819

  • Pfizer Investigational Site

    Sacramento, California, 95825

  • Pfizer Investigational Site

    Salisbury, Maryland, 21801

  • Pfizer Investigational Site

    San Francisco, California, 94115

  • Pfizer Investigational Site

    San Francisco, California, 94118-3110

  • Pfizer Investigational Site

    San Francisco, California, 94143-0648

  • Pfizer Investigational Site

    Sandusky, Ohio, 44870

  • Pfizer Investigational Site

    Santa Rosa, California, 95403

  • Pfizer Investigational Site

    Santa Rosa, California, 95404

  • Pfizer Investigational Site

    Sarasota, Florida, 34239

  • Pfizer Investigational Site

    Springdale, Arkansas, 72764

  • Pfizer Investigational Site

    St. Petersburg, Florida, 33709

  • Pfizer Investigational Site

    Stanford, California, 94305

  • Pfizer Investigational Site

    Tacoma, Washington, 98405

  • Pfizer Investigational Site

    Takoma Park, Maryland, 20912

  • Pfizer Investigational Site

    Tampa, Florida, 33613

  • Pfizer Investigational Site

    Towson, Maryland, 21204

  • Pfizer Investigational Site

    Tucson, Arizona, 85724

  • Pfizer Investigational Site

    Tulsa, Oklahoma, 74104

  • Pfizer Investigational Site

    Washington D.C., District of Columbia, 20010

Other trials in United States

Canada15 sites
  • Pfizer Investigational Site

    Edmonton, Alberta, T6G 2B7

  • Pfizer Investigational Site

    Fleurimont, Quebec, J1H 5N4

  • Pfizer Investigational Site

    Halifax, Nova Scotia, B3H 3A7

  • Pfizer Investigational Site

    Kingston, Ontario, K7L 2V7

  • Pfizer Investigational Site

    Kingston, Ontario, K7L 5G2

  • Pfizer Investigational Site

    London, Ontario, N6A 5A5

  • Pfizer Investigational Site

    Montreal, Quebec, H1T 1C8

  • Pfizer Investigational Site

    Montreal, Quebec, H3A 1A1

  • Pfizer Investigational Site

    Regina, Saskatchewan, S4P 0W5

  • Pfizer Investigational Site

    Saskatoon, Saskatchewan, S7N 0W8

  • Pfizer Investigational Site

    Toronto, Ontario, M4N 3M5

  • Pfizer Investigational Site

    Toronto, Ontario, M5G 2C4

  • Pfizer Investigational Site

    Vancouver, British Columbia, V5Z 1M9

  • Pfizer Investigational Site

    Vancouver, British Columbia, V6Z 1Y6

  • Pfizer Investigational Site

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Israel12 sites
  • Pfizer Investigational Site

    Beersheba

  • Pfizer Investigational Site

    Haifa, 34362

  • Pfizer Investigational Site

    Haifa

  • Pfizer Investigational Site

    Holon, 58100

  • Pfizer Investigational Site

    Jerusalem, 91004

  • Pfizer Investigational Site

    Jerusalem, 91031

  • Pfizer Investigational Site

    Jerusalem, 91120

  • Pfizer Investigational Site

    Petah Tikva, 49261

  • Pfizer Investigational Site

    Ramat Gan

  • Pfizer Investigational Site

    Rehovot

  • Pfizer Investigational Site

    Tel Aviv

  • Pfizer Investigational Site

    Tel HaShomer, 52651

Other trials in Israel

South Africa12 sites
  • Pfizer Investigational Site

    Bloemfontein, Free State

  • Pfizer Investigational Site

    Bloemfontein, 9300

  • Pfizer Investigational Site

    Durban, KwaZulu-Natal

  • Pfizer Investigational Site

    Johannesburg, Gauteng

  • Pfizer Investigational Site

    Les Marais, Pretoria, 0084

  • Pfizer Investigational Site

    Parow, Western Cape, 7500

  • Pfizer Investigational Site

    Pretoria, Gauteng, 0002

  • Pfizer Investigational Site

    Pretoria, Gauteng, 0084

  • Pfizer Investigational Site

    Pretoria, Gauteng, 0140

  • Pfizer Investigational Site

    Pretoria, Gauteng

  • Pfizer Investigational Site

    Pretoria, 0002

  • Pfizer Investigational Site

    Pretoria, 0040

Other trials in South Africa

Germany10 sites
  • Pfizer Investigational Site

    Aachen, 52074

  • Pfizer Investigational Site

    Bonn, 53105

  • Pfizer Investigational Site

    Giessen, 35385

  • Pfizer Investigational Site

    Göttingen, 37075

  • Pfizer Investigational Site

    Hamburg, 20251

  • Pfizer Investigational Site

    Heidelberg, 69120

  • Pfizer Investigational Site

    Kassel, 34125

  • Pfizer Investigational Site

    Kiel, 24105

  • Pfizer Investigational Site

    München, 81377

  • Pfizer Investigational Site

    Münster, 48149

Other trials in Germany

Czechia6 sites
  • Pfizer Investigational Site

    České Budějovice, 370 87

  • Pfizer Investigational Site

    Prague, 100 34

  • Pfizer Investigational Site

    Prague, 128 00

  • Pfizer Investigational Site

    Prague, 14220

  • Pfizer Investigational Site

    Prague, 150 00

  • Pfizer Investigational Site

    Prague, 15500

Other trials in Czechia

United Kingdom6 sites
  • Pfizer Investigational Site

    Edinburgh, Eh3 9YW

  • Pfizer Investigational Site

    Liverpool

  • Pfizer Investigational Site

    London, E2 9JX

  • Pfizer Investigational Site

    London, SE1 7EH

  • Pfizer Investigational Site

    Middlesbrough, TS4 3BW

  • Pfizer Investigational Site

    Oxford, OX3 9DU

Other trials in United Kingdom

Belgium5 sites
  • Pfizer Investigational Site

    Brussels, 1070

  • Pfizer Investigational Site

    Brussels, 1090

  • Pfizer Investigational Site

    Edegem, 2650

  • Pfizer Investigational Site

    Genk, 3600

  • Pfizer Investigational Site

    Liège, B-4000

Other trials in Belgium

Mexico5 sites
  • Pfizer Investigational Site

    Mexico City, Mexico City, 03100

  • Pfizer Investigational Site

    Mexico City, Mexico City, 06720

  • Pfizer Investigational Site

    Mexico City, Mexico City, 14050

  • Pfizer Investigational Site

    Mexico City, Mexico DF, 07760

  • Pfizer Investigational Site

    Mexico City, Mexico, DF, 14000

Other trials in Mexico

Poland5 sites
  • Pfizer Investigational Site

    Bialystok, 15-276

  • Pfizer Investigational Site

    Krakow, 31-202

  • Pfizer Investigational Site

    Poznan, 61-848

  • Pfizer Investigational Site

    Szczecin, 70-111

  • Pfizer Investigational Site

    Warsaw, 02-097

Other trials in Poland

Romania5 sites
  • Pfizer Investigational Site

    Bucharest, 7000

  • Pfizer Investigational Site

    Bucharest, 71406

  • Pfizer Investigational Site

    Bucharest, 771181

  • Pfizer Investigational Site

    Cluj-Napoca, 3400

  • Pfizer Investigational Site

    Timișoara, 1900

Other trials in Romania

Argentina4 sites
  • Pfizer Investigational Site

    Buenos Aires, 1118

  • Pfizer Investigational Site

    Buenos Aires, 1416

  • Pfizer Investigational Site

    Buenos Aires, C1405DCS

  • Pfizer Investigational Site

    Morón, Pcia. de Buenos Aires, 1708

Other trials in Argentina

Colombia4 sites
  • Pfizer Investigational Site

    Bogota, Cundinamarca, 000

  • Pfizer Investigational Site

    Bogotá

  • Pfizer Investigational Site

    Cali, Valle del Cauca Department, Nap

  • Pfizer Investigational Site

    Floridablanca, Santander Department, 000

Other trials in Colombia

Finland4 sites
  • Pfizer Investigational Site

    Kuopio, 70211

  • Pfizer Investigational Site

    Kuopio

  • Pfizer Investigational Site

    Oulu

  • Pfizer Investigational Site

    Turku, FIN-20520

Other trials in Finland

Italy4 sites
  • Pfizer Investigational Site

    Florence, 50134

  • Pfizer Investigational Site

    Milan, 20138

  • Pfizer Investigational Site

    Pavia, 27100

  • Pfizer Investigational Site

    Pisa, 56125

Other trials in Italy

Spain4 sites
  • Pfizer Investigational Site

    Barcelona, 08025

  • Pfizer Investigational Site

    Barcelona, 08907

  • Pfizer Investigational Site

    Madrid, 28046

  • Pfizer Investigational Site

    Valencia, 46010

Other trials in Spain

Australia3 sites
  • Pfizer Investigational Site

    Ashford, South Australia, 5035

  • Pfizer Investigational Site

    Auchenflower, Queensland, 4066

  • Pfizer Investigational Site

    Clayton, Victoria, 3168

Other trials in Australia

Netherlands3 sites
  • Pfizer Investigational Site

    Breda, 4836 AE

  • Pfizer Investigational Site

    Eindhoven, 5623 EJ

  • Pfizer Investigational Site

    Zwolle, 8011 JW

Other trials in Netherlands

Sweden3 sites
  • Pfizer Investigational Site

    Örebro, SE-701 85

  • Pfizer Investigational Site

    Stockholm, 171 76

  • Pfizer Investigational Site

    Uppsala, SE 751 85

Other trials in Sweden

Denmark2 sites
  • Pfizer Investigational Site

    Copenhagen, 2100

  • Pfizer Investigational Site

    Odense C, 5000

Other trials in Denmark

Russia2 sites
  • Pfizer Investigational Site

    Moscow, 119992

  • Pfizer Investigational Site

    Moscow, 123182

Other trials in Russia

Slovakia2 sites
  • Pfizer Investigational Site

    Bratislava, 833 48

  • Pfizer Investigational Site

    Košice, 040-11

Other trials in Slovakia

Switzerland2 sites
  • Pfizer Investigational Site

    Bern, 3010

  • Pfizer Investigational Site

    Geneva, 1211

Other trials in Switzerland

Austria1 site
  • Pfizer Investigational Site

    Graz, 8036

Other trials in Austria

Ireland1 site
  • Pfizer Investigational Site

    Dublin

Other trials in Ireland

Norway1 site
  • Pfizer Investigational Site

    Feiring, 2093

Other trials in Norway

Singapore1 site
  • Pfizer Investigational Site

    Singapore, 168752

Other trials in Singapore

About this study

Official title: A Double-Blind Multicenter Study of the Safety and Efficacy of Parecoxib Sodium/Valdecoxib and Placebo/Valdecoxib Compared to Placebo for Treatment of Post-Surgical Pain in Patients Who Have Coronary Bypass Graft Via Median Sternotomy

The purpose of this study is to evaluate the efficacy and safety of parecoxib/valdecoxib therapy and placebo/valdecoxib therapy for the treatment of pain after coronary artery bypass surgery

Conditions
Pain
Being tested
Parecoxib Sodium/Valdecoxib, Placebo/Valdecoxib, Placebo/Placebo
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parecoxib Sodium/ValdecoxibDrug

    Parecoxib sodium 40 mg intravenous (IV) on the day after surgery (Day 1) following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received parecoxib 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV parecoxib sodium, patients were transitioned to oral valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.

  • Placebo/ValdecoxibDrug

    Patients received placebo matched to parecoxib sodium 40 mg IV on Day 1 following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of placebo matched to parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received placebo matched to parecoxib sodium 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV placebo, patients were transitioned to oral valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.

  • Placebo/PlaceboOther

    Patients received placebo matched to parecoxib sodium 40 mg IV on Day 1 following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of placebo matched to parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received placebo matched to parecoxib sodium 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV placebo, patients were transitioned to oral placebo matched to valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.

Study groups in NCT00636064
Study groupRoleWhat they receive
APlacebo comparatorNot described
Receives: Drug: Parecoxib Sodium/Valdecoxib
BExperimentalNot described
Receives: Drug: Placebo/Valdecoxib
CExperimentalNot described
Receives: Other: Placebo/Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combined incidence of the number of patients with at least 1 confirmed clinically relevant adverse event (CRAE)

    Measured: Day 30

Secondary outcomes (15)
  1. Combined incidence of the number of patients with at least 1 reported CRAE and the combined incidence of the number of patients with specific reported CRAEs summarized according to the categories listed above

    Measured: Day 30

  2. Rate of supplemental analgesia consumed

    Measured: Days 1-10

  3. Vital signs

    Measured: Day 30

  4. Summed Pain Intensity (SPI) of sternotomy alone and overall body pain over 8 hours (SPI 8)

    Measured: Day 1

  5. Opioid-related Symptoms Distress Scale (OR-SDS)

    Measured: Days 1-10

  6. Time to last Patient Controlled Analgesia (PCA) dose

  7. Recovery measures (length of stay, intensive care unit/hospital recovery and eligibility for discharge)

  8. Combined incidence of the number of patients with specific confirmed CRAEs in categories of cardiovascular thromboembolic CRAEs, renal CRAEs, upper gastrointestinal ulcer CRAEs, and wound healing complication CRAEs

    Measured: Day 30

  9. Adverse events

    Measured: Day 30

  10. Serious adverse events

    Measured: Day 30

  11. Clinical laboratory assessments

    Measured: Day 30

  12. Peak Pain Intensity (PPI) of sternotomy alone and overall body pain

    Measured: Days 1-10

  13. Patient's and Physician's Global Evaluation of Study Medication

    Measured: At time of transition from intravenous to oral medication and final visit/early termination

  14. Modified Brief Pain Inventory-short form (mBPI-sf)

    Measured: Days 1-10

  15. SPI of sternotomy alone and overall body pain over 12 hours (SPI 12) and 24 hours (SPI 24)

    Measured: Days 1-10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2008 (estimated)
  2. Study startJan 2003
  3. Study completionJan 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,671 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00636064
Sponsor's protocol ID
PARA-0505-071
Other IDs
A3481015
Status last verified
Mar 2008
First submitted
7 Mar 2008
Last updated
10 Oct 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Parecoxib Sodium/Valdecoxib in people with Pain, run by Pfizer at 206 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 206 sites in United States, Canada, Israel, South Africa, Germany and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined incidence of the number of patients with at least 1 confirmed clinically relevant adverse event (CRAE) (time frame: Day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2008; AzTrials last refreshed its copy on 6 Nov 2026.

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