Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood (FIRST)

June 1, 2018 updated by: AbbVie (prior sponsor, Abbott)

Evaluation of Choline Fenofibrate (ABT-335) on Carotid Intima-Media Thickness (cIMT) in Subjects With Type IIb Dyslipidemia With Residual Risk in Addition to Atorvastatin Therapy (FIRST) Trial

The primary purpose of this study is to test the effect and safety of once daily ABT-335 on the thickness of the lining of the carotid artery (a blood vessel to the brain) in patients with abnormal blood lipids who have optimal levels of low density lipoprotein cholesterol ("bad cholesterol") after taking atorvastatin.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
682

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Site Reference ID/Investigator# 6747
      • Gilbert, Arizona, United States, 85295
        • Site Reference ID/Investigator# 7089
      • Mesa, Arizona, United States, 85206
        • Site Reference ID/Investigator# 7097
      • Phoenix, Arizona, United States, 85032
        • Site Reference ID/Investigator# 26394
      • Scottsdale, Arizona, United States, 85251
        • Site Reference ID/Investigator# 6848
      • Tempe, Arizona, United States, 85282
        • Site Reference ID/Investigator# 7059
      • Tempe, Arizona, United States, 85282
        • Site Reference ID/Investigator# 7094
      • Tempe, Arizona, United States, 85282
        • Site Reference ID/Investigator# 7098
    • California
      • Anaheim, California, United States, 92804
        • Site Reference ID/Investigator# 25082
      • Corona, California, United States, 92879-3109
        • Site Reference ID/Investigator# 21347
      • Garden Grove, California, United States, 92843
        • Site Reference ID/Investigator# 21483
      • Huntington Beach, California, United States, 92648
        • Site Reference ID/Investigator# 21351
      • Laguna Hills, California, United States, 92653
        • Site Reference ID/Investigator# 21346
      • Long Beach, California, United States, 90806
        • Site Reference ID/Investigator# 21341
      • Norwalk, California, United States, 90650
        • Site Reference ID/Investigator# 21342
      • Santa Ana, California, United States, 92705
        • Site Reference ID/Investigator# 21321
      • Tustin, California, United States, 92780
        • Site Reference ID/Investigator# 26242
    • Colorado
      • Arvada, Colorado, United States, 80005-3927
        • Site Reference ID/Investigator# 15283
      • Aurora, Colorado, United States, 80012
        • Site Reference ID/Investigator# 7085
      • Denver, Colorado, United States, 80239
        • Site Reference ID/Investigator# 6749
      • Denver, Colorado, United States, 80246
        • Site Reference ID/Investigator# 7077
      • Golden, Colorado, United States, 80401
        • Site Reference ID/Investigator# 7092
      • Littleton, Colorado, United States, 80122
        • Site Reference ID/Investigator# 7722
      • Littleton, Colorado, United States, 80127
        • Site Reference ID/Investigator# 7721
    • Florida
      • Aventura, Florida, United States, 33180
        • Site Reference ID/Investigator# 11925
      • Boynton Beach, Florida, United States, 33472
        • Site Reference ID/Investigator# 15861
      • Deerfield Beach, Florida, United States, 33442
        • Site Reference ID/Investigator# 14422
      • Delray Beach, Florida, United States, 33445
        • Site Reference ID/Investigator# 19281
      • Hollywood, Florida, United States, 33021
        • Site Reference ID/Investigator# 20881
      • Kissimmee, Florida, United States, 34741
        • Site Reference ID/Investigator# 20882
      • Melbourne, Florida, United States, 32901
        • Site Reference ID/Investigator# 19321
      • Melbourne, Florida, United States, 32901
        • Site Reference ID/Investigator# 21353
      • Melbourne, Florida, United States, 32935
        • Site Reference ID/Investigator# 18503
      • Vero Beach, Florida, United States, 32960
        • Site Reference ID/Investigator# 18841
      • Vero Beach, Florida, United States, 32960
        • Site Reference ID/Investigator# 19961
      • West Palm Beach, Florida, United States, 33401
        • Site Reference ID/Investigator# 7166
      • West Palm Beach, Florida, United States, 33407
        • Site Reference ID/Investigator# 6744
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Site Reference ID/Investigator# 19301
      • Atlanta, Georgia, United States, 30342-1524
        • Site Reference ID/Investigator# 7051
      • Atlanta, Georgia, United States, 30342
        • Site Reference ID/Investigator# 7109
      • Dawsonville, Georgia, United States, 30534
        • Site Reference ID/Investigator# 7326
      • Decatur, Georgia, United States, 30033
        • Site Reference ID/Investigator# 7325
      • Dunwoody, Georgia, United States, 30338
        • Site Reference ID/Investigator# 7057
      • Dunwoody, Georgia, United States, 30338
        • Site Reference ID/Investigator# 7101
      • Roswell, Georgia, United States, 30076
        • Site Reference ID/Investigator# 11324
      • Roswell, Georgia, United States, 30076
        • Site Reference ID/Investigator# 6741
      • Suwanee, Georgia, United States, 30024
        • Site Reference ID/Investigator# 7103
    • Illinois
      • Addison, Illinois, United States, 60101
        • Site Reference ID/Investigator# 10761
      • Aurora, Illinois, United States, 60504
        • Site Reference ID/Investigator# 6748
      • Aurora, Illinois, United States, 60506
        • Site Reference ID/Investigator# 6742
      • Belleville, Illinois, United States, 62220-1986
        • Site Reference ID/Investigator# 7128
      • Chicago, Illinois, United States, 60607
        • Site Reference ID/Investigator# 7069
      • Chicago, Illinois, United States, 60612-9985
        • Site Reference ID/Investigator# 6849
      • Chicago, Illinois, United States, 60612
        • Site Reference ID/Investigator# 6867
      • Chicago, Illinois, United States, 60616
        • Site Reference ID/Investigator# 6751
      • Chicago, Illinois, United States, 60631
        • Site Reference ID/Investigator# 6847
      • Chicago, Illinois, United States, 60654
        • Site Reference ID/Investigator# 7049
      • Gurnee, Illinois, United States, 60031
        • Site Reference ID/Investigator# 7093
      • Hazel Crest, Illinois, United States, 60429
        • Site Reference ID/Investigator# 6746
      • Melrose Park, Illinois, United States, 60160
        • Site Reference ID/Investigator# 6743
      • Naperville, Illinois, United States, 60564
        • Site Reference ID/Investigator# 7090
      • Oak Brook, Illinois, United States, 60523
        • Site Reference ID/Investigator# 6750
      • Oak Park, Illinois, United States, 60304
        • Site Reference ID/Investigator# 6788
      • Vernon Hills, Illinois, United States, 60061
        • Site Reference ID/Investigator# 6927
    • Kentucky
      • Erlanger, Kentucky, United States, 41018
        • Site Reference ID/Investigator# 7076
    • Minnesota
      • Bloomington, Minnesota, United States, 55420
        • Site Reference ID/Investigator# 8103
      • Brooklyn Center, Minnesota, United States, 55430
        • Site Reference ID/Investigator# 15121
      • Edina, Minnesota, United States, 55435
        • Site Reference ID/Investigator# 7050
      • Edina, Minnesota, United States, 55435
        • Site Reference ID/Investigator# 7084
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Site Reference ID/Investigator# 6860
      • Saint Louis, Missouri, United States, 63117
        • Site Reference ID/Investigator# 13182
      • Saint Louis, Missouri, United States, 63128
        • Site Reference ID/Investigator# 14423
      • Saint Louis, Missouri, United States, 63141-6399
        • Site Reference ID/Investigator# 14541
      • Saint Louis, Missouri, United States, 63141
        • Site Reference ID/Investigator# 6740
      • Saint Louis, Missouri, United States, 63141
        • Site Reference ID/Investigator# 7053
      • Saint Peters, Missouri, United States, 63376
        • Site Reference ID/Investigator# 6784
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Site Reference ID/Investigator# 7063
      • Henderson, Nevada, United States, 89052
        • Site Reference ID/Investigator# 7070
      • Las Vegas, Nevada, United States, 89104
        • Site Reference ID/Investigator# 7106
      • Las Vegas, Nevada, United States, 89106
        • Site Reference ID/Investigator# 7518
      • Las Vegas, Nevada, United States, 89146
        • Site Reference ID/Investigator# 7119
      • Las Vegas, Nevada, United States, 89148
        • Site Reference ID/Investigator# 7129
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Site Reference ID/Investigator# 7071
      • Cincinnati, Ohio, United States, 45219
        • Site Reference ID/Investigator# 7100
      • Cincinnati, Ohio, United States, 45224
        • Site Reference ID/Investigator# 14321
      • Cincinnati, Ohio, United States, 45245
        • Site Reference ID/Investigator# 21355
      • Cincinnati, Ohio, United States, 45246
        • Site Reference ID/Investigator# 7074
      • Cincinnati, Ohio, United States, 45249
        • Site Reference ID/Investigator# 7065
      • Dayton, Ohio, United States, 45439
        • Site Reference ID/Investigator# 7075
      • Kettering, Ohio, United States, 45429
        • Site Reference ID/Investigator# 24802
      • Mason, Ohio, United States, 45040
        • Site Reference ID/Investigator# 7068
    • Texas
      • Bellaire, Texas, United States, 77401
        • Site Reference ID/Investigator# 7104
      • Carrollton, Texas, United States, 75006-5810
        • Site Reference ID/Investigator# 7060
      • Dallas, Texas, United States, 75230
        • Site Reference ID/Investigator# 15282
      • Dallas, Texas, United States, 75231
        • Site Reference ID/Investigator# 6745
      • Dallas, Texas, United States, 75231
        • Site Reference ID/Investigator# 7083
      • Dallas, Texas, United States, 75231
        • Site Reference ID/Investigator# 7127
      • Dallas, Texas, United States, 75251
        • Site Reference ID/Investigator# 7110
      • Deer Park, Texas, United States, 77536
        • Site Reference ID/Investigator# 21356
      • Fort Worth, Texas, United States, 76116
        • Site Reference ID/Investigator# 11923
      • Houston, Texas, United States, 77002
        • Site Reference ID/Investigator# 7321
      • Houston, Texas, United States, 77024
        • Site Reference ID/Investigator# 21354
      • Houston, Texas, United States, 77030
        • Site Reference ID/Investigator# 21358
      • Houston, Texas, United States, 77030
        • Site Reference ID/Investigator# 26482
      • Houston, Texas, United States, 77030
        • Site Reference ID/Investigator# 7079
      • Houston, Texas, United States, 77030
        • Site Reference ID/Investigator# 7096
      • Houston, Texas, United States, 77036
        • Site Reference ID/Investigator# 7126
      • Houston, Texas, United States, 77036
        • Site Reference ID/Investigator# 8186
      • Houston, Texas, United States, 77074
        • Site Reference ID/Investigator# 11323
      • Houston, Texas, United States, 77081
        • Site Reference ID/Investigator# 7130
      • Irving, Texas, United States, 75039
        • Site Reference ID/Investigator# 11924
      • Irving, Texas, United States, 75061
        • Site Reference ID/Investigator# 13863
      • McKinney, Texas, United States, 75069
        • Site Reference ID/Investigator# 7099
      • New Braunfels, Texas, United States, 78130
        • Site Reference ID/Investigator# 19121
      • Pearland, Texas, United States, 77584
        • Site Reference ID/Investigator# 26244
      • Plano, Texas, United States, 75024
        • Site Reference ID/Investigator# 7105
      • San Antonio, Texas, United States, 78205
        • Site Reference ID/Investigator# 7061
      • San Antonio, Texas, United States, 78215
        • Site Reference ID/Investigator# 7320
      • San Antonio, Texas, United States, 78218
        • Site Reference ID/Investigator# 7914
      • San Antonio, Texas, United States, 78229-4801
        • Site Reference ID/Investigator# 7058
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator# 18402
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator# 7052
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator# 7062
      • San Antonio, Texas, United States, 78238-1434
        • Site Reference ID/Investigator# 22947

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with mixed dyslipidemia
  • Qualifying cIMT thickness

Exclusion Criteria:

  • Patients with certain chronic or unstable medical conditions.
  • Patients with unstable dose of medications or receiving coumadin, cyclosporine, or certain other medications
  • Pregnant or lactating women or women intending to become pregnant
  • Patients with diabetes mellitus that is poorly controlled

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ABT-335 + Atorvastatin
ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
Drug: ABT-335
Capsule
Other Names:
  • Fenofibric acid
  • Choline fenofibrate
Other: Atorvastatin
Capsule
Placebo Comparator: Placebo + Atorvastatin
Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
Drug: Placebo
Capsule
Other: Atorvastatin
Capsule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT)
Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of change (mm/year) from baseline in mean of posterior-wall carotid intima-media thickness (cIMT) of the left and right common carotid artery. The statistical model used change from baseline as the dependent variable, with time of cIMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. cIMT was measured using non-invasive ultrasound.
Baseline, 6 months, 12 months, 18 months, and 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of Change in Mean of Maximal Posterior-wall Carotid Intima-media Thickness (cIMT)
Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of change (mm/year) from baseline in mean of maximal posterior-wall carotid intima-media thickness (cIMT) of the left and right common carotid artery. The statistical model used change from baseline as the dependent variable, with time of cIMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. cIMT was measured using non-invasive ultrasound.
Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of Change in Composite of Mean of the Mean Posterior-wall Intima-media Thickness (IMT)
Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of change (mm/year) from baseline in composite of mean of the mean posterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.
Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of Change in Composite of Mean of Maximal Posterior-wall Intima-media Thickness (IMT)
Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of change (mm/year) from baseline in composite of mean of maximal posterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.
Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of Change in Composite of Mean of Maximal Posterior-wall and Anterior-wall Intima-media Thickness (IMT)
Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of change (mm/year) from baseline in composite of mean of maximal posterior-wall and anterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.
Baseline, 6 months, 12 months, 18 months, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie (prior sponsor, Abbott)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Maureen Kelly, MD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M10-158

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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