DyslipidemiaPhase 3NCT00630877
Evaluation of a Flushing ASsessment Tool (FAST) in Subjects Receiving Niacin Extended-release Plus Aspirin
A Phase 3 study testing Niacin extended-release (NER) and Aspirin (ASA) in people with Dyslipidemia, run by Abbott at 40 sites in United States.
Trial summary
The primary purpose of this study was to evaluate the psychometric characteristics (reliability, validity, and responsiveness) of a Flushing ASsessment Tool (FAST) in subjects receiving niacin extended-release (NER) plus aspirin (ASA) daily for 6 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Niacin extended-release (NER) and Aspirin (ASA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 participants
- Where
- 40 sitesUnited States
- Study dates
- Feb 2008to Jun 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be 18 years of age or older.
- If female, subject is either not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile, or is of childbearing potential and must agree to practice birth control for the duration of the study.
- Have dyslipidemia as demonstrated by laboratory results.
Who cannot join
- Have glycosylated hemoglobin (HbA1c) >= 9.0%.
- Have nephrotic syndrome, dysproteinemias, or severe renal failure (glomerular filtration rate [GFR] < 30 mL/minute, as calculated from creatinine clearance).
- Have had unstable angina or an acute myocardial infarction (MI) within three months of the Screening Visit.
- Have had severe peripheral artery disease as evidenced by intermittent claudication within three months of the Screening Visit.
- Have had uncontrolled cardiac arrhythmias within three months of the Screening Visit.
- Have symptomatic heart failure defined as dyspnea at rest or with exertion (mild peripheral edema is not exclusionary).
Show all 12Show fewer
- Have a systolic blood pressure measurement of > 180 mmHg or a diastolic blood pressure measurement of > 110 mmHg at the Screening or Baseline Visit
- Have active gout or uric acid >= 11 mg/dL.
- Have a history of hepatitis (acute or chronic), obstructive liver disease, or alanine aminotransferase (ALT; serum glutamic pyruvic transaminase [SGPT]) or aspartate aminotransferase (AST; serum glutamic oxaloacetic transaminase [SGOT]) values >= 1.3 times the upper limit of normal (ULN) at the Screening Visit.
- Have creatine phosphokinase (CPK) >= 3 x ULN at the Screening Visit.
- Have used an investigational study drug or participated in an investigational study within 30 days of the Screening Visit.
- Have a health condition or laboratory abnormality (inclusive of clinically significant laboratory results at Screening Visit), which, in the opinion of the Investigator, may be adversely affected by the procedures or study medications in this study.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Study site
Anaheim, California, 92801
Study site
Arkansas City, Kansas, 67005
Study site
Austin, Texas, 78752
Study site
Birmingham, Alabama, 35209
Study site
Boise, Idaho, 83704
Study site
Brooksville, Florida, 34613
Study site
Carrollton, Texas, 75006
Study site
Chicago, Illinois, 60610
Study site
Cincinnati, Ohio, 45242
Study site
Dallas, Texas, 75251
Study site
Daytona Beach, Florida, 32127
Study site
Denver, Colorado, 80212
Study site
Duncansville, Pennsylvania, 16635
Study site
Durham, North Carolina, 27704
Study site
Gig Harbor, Washington, 98335
Study site
Greer, South Carolina, 29651
Study site
Harleysville, Pennsylvania, 19438
Study site
High Point, North Carolina, 27262
Study site
Hollywood, Florida, 33023
Study site
Jacksonville, Florida, 32216
Study site
Largo, Florida, 33770
Study site
Las Vegas, Nevada, 89146
Study site
Magna, Utah, 84044
Study site
Menomonee Falls, Wisconsin, 53051
Study site
Miami, Florida, 33126
Study site
Milwaukee, Wisconsin, 53209
Study site
Murray, Utah, 84107
Study site
Pembroke Pines, Florida, 33026
Study site
Pittsburgh, Pennsylvania, 15206
Study site
Portland, Oregon, 97239
Study site
Salisbury, North Carolina, 28144
Study site
San Antonio, Texas, 78217
Study site
San Antonio, Texas, 78224
Study site
Sandy City, Utah, 84094
Study site
St Louis, Missouri, 63141
Study site
Statesville, North Carolina, 28677
Study site
Topeka, Kansas, 66608
Study site
Walnut Creek, California, 94598
Study site
Wichita, Kansas, 67203
Study site
Wichita, Kansas, 67207
About this study
Official title: A Randomized, Double-blind, Parallel, Multicenter, Placebo-controlled, Prospective Study to Evaluate the Functionality of the Flushing ASsessment Tool (FAST) in Subjects Administered Niaspan® Plus Acetylsalicylic Acid (ASA), Niaspan® Plus ASA Placebo or Niaspan® Placebo Plus ASA Placebo Daily for Six Weeks
The primary purpose of this study was to evaluate the psychometric characteristics (reliability, validity, and responsiveness) of a Flushing ASsessment Tool (FAST) in subjects receiving niacin extended-release (NER) plus aspirin (ASA) daily for 6 weeks.
The FAST is a questionnaire that was developed to provide a detailed assessment of flushing symptoms and their impact in patients receiving niacin therapy. The effect of aspirin on flushing symptoms, as measured by the FAST, was also evaluated.
Read the detailed description
This study was designed to evaluate the psychometric characteristics of the FAST questionnaire.
The FAST is a self-administered questionnaire, completed using a hand-held electronic data capture device (LogPad e-diary). Subjects recorded the start and stop date and time of each flushing event, the presence and severity of individual flushing symptoms (redness, warmth, tingling and/or itching), and an overall assessment of their flushing experience.
Evaluation of the psychometric characteristics of the FAST was based on 3 primary data analyses: 1 ) test-retest reliability based on the intraclass correlation coefficient; 2) construct validity based on Spearman correlation coefficients; and 3) responsiveness based on changes in FAST scores. The mean and maximum severity of flushing events, as measured by the FAST, were the primary variables evaluated in each of the 3 data analyses mentioned above. Psychometric analyses were performed blinded to treatment group assignment.
- Conditions
- Dyslipidemia
- Being tested
- Niacin extended-release (NER), Niacin extended-release (NER) placebo, Aspirin (ASA), Aspirin (ASA) placebo
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niacin extended-release (NER)Drug
Also called ABT-919, Niaspan
Tablets administered once daily for 6 weeks; titrated to a maximum dose of 2000 mg
Niacin extended-release (NER) placeboDrug
Tablets administered once daily for 6 weeks
Aspirin (ASA)Drug
Also called acetylsalicylic acid
Tablets (325 mg) administered once daily for 6 weeks
Aspirin (ASA) placeboDrug
Tablets administered once daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| NER/ASA | Experimental | Not described Receives: Drug: Niacin extended-release (NER); Drug: Aspirin (ASA) |
| NER/ASA Placebo | Experimental | Not described Receives: Drug: Niacin extended-release (NER); Drug: Aspirin (ASA) placebo |
| NER Placebo/ASA Placebo | Experimental | Not described Receives: Drug: Niacin extended-release (NER) placebo; Drug: Aspirin (ASA) placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score
Test-retest reliability of the mean flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.
Measured: Week 1 to Week 2
FAST Test-retest Reliability--maximum Flushing Severity Score
Test-retest reliability of the maximum flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.
Measured: Week 1 to Week 2
FAST Cross-sectional Construct Validity--mean Flushing Severity Score
The relationship between mean flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.
Measured: Week 1
FAST Cross-sectional Construct Validity--maximum Flushing Severity Score
The relationship between maximum flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.
Measured: Week 1
FAST Longitudinal Construct Validity--mean Flushing Severity Score
The relationship between the change in mean flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).
Measured: Week 1 to Week 2
FAST Longitudinal Construct Validity--maximum Flushing Severity Score
The relationship between the change in maximum flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).
Measured: Week 1 to Week 2
FAST Responsiveness--mean Flushing Severity Score
The change in mean flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in mean flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.
Measured: Study start to Day 43
FAST Responsiveness--maximum Flushing Severity Score
The change in maximum flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in maximum flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.
Measured: Study start to Day 43
Secondary outcomes (1)
Maximum Severity of Flushing Events Overall During the Study
The severity of flushing events was assessed as none, mild, moderate, severe, or very severe using the FAST. The maximum severity of flushing events overall during the study was compared among treatment groups.
Measured: Week 1 to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Roopal Thakkar, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630877
- Sponsor's protocol ID
- M10-229
- Status last verified
- Sep 2009
- First submitted
- 29 Feb 2008
- Last updated
- 9 Oct 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kawata AK, Revicki DA, Thakkar R, Jiang P, Krause S, Davidson MH, Punzi HA, Padley RJ. Flushing ASsessment Tool (FAST): psychometric properties of a new measure assessing flushing symptoms and clinical impact of niacin therapy. Clin Drug Investig. 2009;29(4):215-29. doi: 10.2165/00044011-200929040-00001.
PubMed 19301936
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel, Multicenter, Placebo-controlled, Prospective Study to Evaluate the Functionality of the Flushing ASsessment Tool (FAST) in Subjects Administered Niaspan® Plus Acetylsalicylic Acid (ASA), Niaspan® Plus ASA Placebo or Niaspan® Placebo Plus ASA Placebo Daily for Six Weeks
- ClinicalTrials.gov ID
- NCT00630877
- Acronym / sponsor ID
- M10-229
- Conditions
- Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 7 Mar 2008 (estimated)
- Results
- Posted 9 Oct 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study was to evaluate the psychometric characteristics (reliability, validity, and responsiveness) of a Flushing ASsessment Tool (FAST) in subjects receiving niacin extended-release (NER) plus aspirin (ASA) daily for 6 weeks.
The FAST is a questionnaire that was developed to provide a detailed assessment of flushing symptoms and their impact in patients receiving niacin therapy. The effect of aspirin on flushing symptoms, as measured by the FAST, was also evaluated.
Detailed description
This study was designed to evaluate the psychometric characteristics of the FAST questionnaire.
The FAST is a self-administered questionnaire, completed using a hand-held electronic data capture device (LogPad e-diary). Subjects recorded the start and stop date and time of each flushing event, the presence and severity of individual flushing symptoms (redness, warmth, tingling and/or itching), and an overall assessment of their flushing experience.
Evaluation of the psychometric characteristics of the FAST was based on 3 primary data analyses: 1 ) test-retest reliability based on the intraclass correlation coefficient; 2) construct validity based on Spearman correlation coefficients; and 3) responsiveness based on changes in FAST scores. The mean and maximum severity of flushing events, as measured by the FAST, were the primary variables evaluated in each of the 3 data analyses mentioned above. Psychometric analyses were performed blinded to treatment group assignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NER/ASA | Experimental | Drug: Niacin extended-release (NER), Drug: Aspirin (ASA) |
| NER/ASA Placebo | Experimental | Drug: Niacin extended-release (NER), Drug: Aspirin (ASA) placebo |
| NER Placebo/ASA Placebo | Experimental | Drug: Niacin extended-release (NER) placebo, Drug: Aspirin (ASA) placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject must be 18 years of age or older.
- If female, subject is either not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile, or is of childbearing potential and must agree to practice birth control for the duration of the study.
- Have dyslipidemia as demonstrated by laboratory results.
Key exclusion criteria (12 listed)
- Have glycosylated hemoglobin (HbA1c) >= 9.0%.
- Have nephrotic syndrome, dysproteinemias, or severe renal failure (glomerular filtration rate [GFR] < 30 mL/minute, as calculated from creatinine clearance).
- Have had unstable angina or an acute myocardial infarction (MI) within three months of the Screening Visit.
- Have had severe peripheral artery disease as evidenced by intermittent claudication within three months of the Screening Visit.
- Have had uncontrolled cardiac arrhythmias within three months of the Screening Visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niacin extended-release (NER)Also: ABT-919, NiaspanTablets administered once daily for 6 weeks; titrated to a maximum dose of 2000 mg | Drug | NER/ASA, NER/ASA Placebo |
| Niacin extended-release (NER) placeboTablets administered once daily for 6 weeks | Drug | NER Placebo/ASA Placebo |
| Aspirin (ASA)Also: acetylsalicylic acidTablets (325 mg) administered once daily for 6 weeks | Drug | NER/ASA |
| Aspirin (ASA) placeboTablets administered once daily for 6 weeks | Drug | NER Placebo/ASA Placebo, NER/ASA Placebo |
Primary outcome
Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score
Time frame: Week 1 to Week 2
Test-retest reliability of the mean flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.
FAST Test-retest Reliability--maximum Flushing Severity Score
Time frame: Week 1 to Week 2
Test-retest reliability of the maximum flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.
FAST Cross-sectional Construct Validity--mean Flushing Severity Score
Time frame: Week 1
The relationship between mean flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.
FAST Cross-sectional Construct Validity--maximum Flushing Severity Score
Time frame: Week 1
The relationship between maximum flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.
FAST Longitudinal Construct Validity--mean Flushing Severity Score
Time frame: Week 1 to Week 2
The relationship between the change in mean flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).
FAST Longitudinal Construct Validity--maximum Flushing Severity Score
Time frame: Week 1 to Week 2
The relationship between the change in maximum flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).
FAST Responsiveness--mean Flushing Severity Score
Time frame: Study start to Day 43
The change in mean flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in mean flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.
FAST Responsiveness--maximum Flushing Severity Score
Time frame: Study start to Day 43
The change in maximum flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in maximum flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.
1 secondary outcome
Maximum Severity of Flushing Events Overall During the Study
Time frame: Week 1 to Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19301936Kawata AK, Revicki DA, Thakkar R, Jiang P, Krause S, Davidson MH, Punzi HA, Padley RJ. Flushing ASsessment Tool (FAST): psychometric properties of a new measure assessing flushing symptoms and clinical impact of niacin therapy. Clin Drug Investig. 2009;29(4):215-29. doi: 10.2165/00044011-200929040-00001.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roopal Thakkar, MD study director
Abbott
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Niacin extended-release (NER) and Aspirin (ASA) in people with Dyslipidemia, run by Abbott at 40 sites in United States.
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 3 inclusion and 12 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 9 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States. 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. 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?
Yes. Results are posted in the registry (first posted 9 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score (time frame: Week 1 to Week 2). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00630877, which also lists 1 linked publication.
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 9 Oct 2009.