AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD)

May 17, 2011 updated by: AstraZeneca

A Study to Evaluate the Use of Rosuvastatin in Subjects On Regular Haemodialysis: an Assessment of Survival and Cardiovascular Events (AURORA). A Double Blind, Randomised, Phase 3b, Parallel-group Study to Compare the Effects of Rosuvastatin With Placebo on Assessment of Survival & Cardiovascular Events When Given to Subjects With End-stage Renal Failure on Chronic Haemodialysis Treatment

The purpose of this study is to see if rosuvastatin helps to reduce the number of heart attacks, strokes and cardiovascular deaths in patients undergoing haemodialysis.

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.
2776

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

  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia
        • Research Site
    • Queensland
      • Herston, Queensland, Australia
        • Research Site
  • Austria
      • Bregenz, Austria
        • Research Site
      • Feldkirch-Tisis, Austria
        • Research Site
      • Graz, Austria
        • Research Site
      • Innsbruck, Austria
        • Research Site
      • Linz, Austria
        • Research Site
      • St. Poelten, Austria
        • Research Site
      • Wels, Austria
        • Research Site
      • Wien, Austria
        • Research Site
  • Belgium
      • Aalst, Belgium
        • Research Site
      • Antwerpen, Belgium
        • Research Site
      • Brussels, Belgium
        • Research Site
      • La Louviere, Belgium
        • Research Site
      • Leuven, Belgium
        • Research Site
      • Liège, Belgium
        • Research Site
  • Brazil
    • PR
      • Curitiba, PR, Brazil
        • Research Site
    • SP
      • Sao Paulo, SP, Brazil
        • Research Site
  • Bulgaria
      • Pleven, Bulgaria
        • Research Site
      • Plovdiv, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
  • Canada
      • Kitchener, Canada
        • Research Site
      • Rosemount, Canada
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
      • Edmonton, Alberta, Canada
        • Research Site
      • Lethbridge, Alberta, Canada
        • Research Site
    • British Columbia
      • Kelowna, British Columbia, Canada
        • Research Site
      • Vancouver, British Columbia, Canada
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Research Site
    • New Brunswick
      • Saint John, New Brunswick, Canada
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Research Site
    • Ontario
      • London, Ontario, Canada
        • Research Site
      • Mississauga, Ontario, Canada
        • Research Site
      • Scarborough, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
      • York, Ontario, Canada
        • Research Site
    • Quebec
      • Greenfield Park, Quebec, Canada
        • Research Site
      • Laval, Quebec, Canada
        • Research Site
      • Montreal, Quebec, Canada
        • Research Site
      • Trois-Rivieres, Quebec, Canada
        • Research Site
  • Czech Republic
      • Hodonin, Czech Republic
        • Research Site
      • Hradec Kralove, Czech Republic
        • Research Site
      • Liberec, Czech Republic
        • Research Site
      • Pardubice, Czech Republic
        • Research Site
      • Praha 2, Czech Republic
        • Research Site
      • Praha 4, Czech Republic
        • Research Site
      • Praha 6, Czech Republic
        • Research Site
      • Tabor, Czech Republic
        • Research Site
      • Usti nad Labem, Czech Republic
        • Research Site
  • Denmark
      • Fredericia, Denmark
        • Research Site
      • Frederiksberg, Denmark
        • Research Site
      • Herlev, Denmark
        • Research Site
      • Holbaek, Denmark
        • Research Site
      • Horsens, Denmark
        • Research Site
      • København Ø, Denmark
        • Research Site
      • Roskilde, Denmark
        • Research Site
      • Rønne, Denmark
        • Research Site
      • Slagelse, Denmark
        • Research Site
      • Sønderborg, Denmark
        • Research Site
      • Viborg, Denmark
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Hyvinkaa, Finland
        • Research Site
      • Joensuu, Finland
        • Research Site
      • Kotka, Finland
        • Research Site
      • Kuopio, Finland
        • Research Site
      • Lahti, Finland
        • Research Site
      • Oulu, Finland
        • Research Site
      • Pori, Finland
        • Research Site
      • Tammisaari, Finland
        • Research Site
      • Tampere, Finland
        • Research Site
      • Turku, Finland
        • Research Site
  • France
      • Amiens, France
        • Research Site
      • Annonay Cedex, France
        • Research Site
      • Aubervilliers, France
        • Research Site
      • Beauvais, France
        • Research Site
      • Bethune Cedex, France
        • Research Site
      • Boulogne Sur Mer, France
        • Research Site
      • Chambery, France
        • Research Site
      • Champigny Sur Marne, France
        • Research Site
      • Colmar Cedex, France
        • Research Site
      • Creil Cedex 1, France
        • Research Site
      • Evreux Cedex, France
        • Research Site
      • Fleury Merogis, France
        • Research Site
      • Foix Cedex, France
        • Research Site
      • Le Kremlin-Bicetre, France
        • Research Site
      • Maubeuge, France
        • Research Site
      • Meaux, France
        • Research Site
      • Mont de Marsan Cedex, France
        • Research Site
      • Montbonnot Saint Martin, France
        • Research Site
      • Nimes, France
        • Research Site
      • Olivet, France
        • Research Site
      • Paris, France
        • Research Site
      • Quimper Cedex, France
        • Research Site
      • Saint Maurice, France
        • Research Site
      • Saint Michel, France
        • Research Site
      • Tournan En Brie, France
        • Research Site
      • Valenciennes Cedex, France
        • Research Site
      • Vandoeuvre Les Nancy, France
        • Research Site
      • Vichy, France
        • Research Site
  • Germany
      • Ansbach, Germany
        • Research Site
      • Aschaffenburg, Germany
        • Research Site
      • Bad Münder, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Bischofswerda, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Duisburg, Germany
        • Research Site
      • Düsseldorf, Germany
        • Research Site
      • Erlangen, Germany
        • Research Site
      • Frankfurt, Germany
        • Research Site
      • Freiburg, Germany
        • Research Site
      • Greifswald, Germany
        • Research Site
      • Hann Münden, Germany
        • Research Site
      • Ingolstadt, Germany
        • Research Site
      • Jena, Germany
        • Research Site
      • Kaufbeuren, Germany
        • Research Site
      • Luedenscheid, Germany
        • Research Site
      • Marktheidenfeld, Germany
        • Research Site
      • München, Germany
        • Research Site
      • Pfarrkirchen, Germany
        • Research Site
      • Pirmasens, Germany
        • Research Site
      • Regensburg, Germany
        • Research Site
      • Rostock, Germany
        • Research Site
      • Saarbrucken, Germany
        • Research Site
      • Tangermünde, Germany
        • Research Site
      • Waldshut, Germany
        • Research Site
  • Greece
      • Alexandroupoli, Greece
        • Research Site
      • Athens, Greece
        • Research Site
      • Ioannina, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
      • Veroia, Greece
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Gyor, Hungary
        • Research Site
      • Miskolc, Hungary
        • Research Site
      • Nyiregyhaza, Hungary
        • Research Site
      • Szeged, Hungary
        • Research Site
      • Székesfehérvár, Hungary
        • Research Site
      • Veszprém, Hungary
        • Research Site
  • Iceland
      • Reykjavik, Iceland
        • Research Site
  • Ireland
      • Galway, Ireland
        • Research Site
  • Italy
    • BG
      • Bergamo, BG, Italy
        • Research Site
      • Treviglio, BG, Italy
        • Research Site
    • CR
      • Cremona, CR, Italy
        • Research Site
    • GE
      • Genova, GE, Italy
        • Research Site
    • LO
      • Lodi, LO, Italy
        • Research Site
    • MI
      • Rozzano, MI, Italy
        • Research Site
    • Mi
      • Milano, Mi, Italy
        • Research Site
    • RC
      • Reggio Calabria, RC, Italy
        • Research Site
    • VA
      • Busto Arsizio, VA, Italy
        • Research Site
  • Korea, Republic of
    • Korea
      • Seongnam-Si, Korea, Korea, Republic of
        • Research Site
      • Seoul, Korea, Korea, Republic of
        • Research Site
  • Mexico
      • Distrito Federal, Mexico
        • Research Site
      • San Luis Potosi, Mexico
        • Research Site
    • D.f.
      • Mexico, D.f., Mexico
        • Research Site
    • Guerrero
      • Acapulco, Guerrero, Mexico
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Research Site
    • Morelos
      • Cuernavaca, Morelos, Mexico
        • Research Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
        • Research Site
  • Netherlands
      • Alkmaar, Netherlands
        • Research Site
      • Almelo, Netherlands
        • Research Site
      • Amersfoort, Netherlands
        • Research Site
      • Amsterdam, Netherlands
        • Research Site
      • Arnhem, Netherlands
        • Research Site
      • Den Bosch, Netherlands
        • Research Site
      • Den Haag, Netherlands
        • Research Site
      • Deventer, Netherlands
        • Research Site
      • Dordrecht, Netherlands
        • Research Site
      • Emmen, Netherlands
        • Research Site
      • Groningen, Netherlands
        • Research Site
      • Leeuwarden, Netherlands
        • Research Site
      • Nieuwegein, Netherlands
        • Research Site
      • Rotterdam, Netherlands
        • Research Site
      • Sittard, Netherlands
        • Research Site
      • Tilburg, Netherlands
        • Research Site
  • Norway
      • Bergen, Norway
        • Research Site
      • Drammen, Norway
        • Research Site
      • Fredrikstad, Norway
        • Research Site
      • Lillehammer, Norway
        • Research Site
      • Lorenskog, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Skien, Norway
        • Research Site
      • Stavanger, Norway
        • Research Site
      • Trondheim, Norway
        • Research Site
      • Tønsberg, Norway
        • Research Site
  • Poland
      • Bialystok, Poland
        • Research Site
      • Gdansk, Poland
        • Research Site
      • Katowice, Poland
        • Research Site
      • Kraków, Poland
        • Research Site
      • Lublin, Poland
        • Research Site
      • Opole, Poland
        • Research Site
      • Plock, Poland
        • Research Site
      • Rybnik, Poland
        • Research Site
      • Wloclawek, Poland
        • Research Site
  • Sweden
      • Eksjö, Sweden
        • Research Site
      • Eskilstuna, Sweden
        • Research Site
      • Falun, Sweden
        • Research Site
      • Gävle, Sweden
        • Research Site
      • Göteborg, Sweden
        • Research Site
      • Jönköping, Sweden
        • Research Site
      • Karlstad, Sweden
        • Research Site
      • Linköping, Sweden
        • Research Site
      • Lund, Sweden
        • Research Site
      • Mölndal, Sweden
        • Research Site
      • Norrköping, Sweden
        • Research Site
      • Skövde, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Trollhättan, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research Site
      • Örebro, Sweden
        • Research Site
  • Switzerland
      • Aarau, Switzerland
        • Research Site
      • Bern, Switzerland
        • Research Site
      • Geneve, Switzerland
        • Research Site
      • Lausanne, Switzerland
        • Research Site
      • St. Gallen, Switzerland
        • Research Site
      • Zürich, Switzerland
        • Research Site
  • Turkey
    • Altunizade
      • Istanbul, Altunizade, Turkey
        • Research Site
    • Ankara
      • Cebeci, Ankara, Turkey
        • Research Site
    • Antalya
      • Kampus, Antalya, Turkey
        • Research Site
    • Arapsuyu
      • Antalya, Arapsuyu, Turkey
        • Research Site
    • Besevler
      • Ankara, Besevler, Turkey
        • Research Site
    • Bornova
      • Izmir, Bornova, Turkey
        • Research Site
    • Gorukle
      • Bursa, Gorukle, Turkey
        • Research Site
    • Haydarpasa
      • Istanbul, Haydarpasa, Turkey
        • Research Site
  • United Kingdom
      • Bradford, United Kingdom
        • Research Site
      • Dumfries, United Kingdom
        • Research Site
      • Dundee, United Kingdom
        • Research Site
      • Glasgow, United Kingdom
        • Research Site
      • Hull, United Kingdom
        • Research Site
      • Kilmarnock, United Kingdom
        • Research Site
      • Leeds, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
      • Middlesborough, United Kingdom
        • Research Site
      • Newcastle, United Kingdom
        • Research Site
      • Plymouth, United Kingdom
        • Research Site
      • Rhyl, United Kingdom
        • Research Site
      • Sheffield, United Kingdom
        • Research Site
      • Surrey, United Kingdom
        • Research Site
    • Northern Ireland
      • Antrim, Northern Ireland, United Kingdom
        • Research Site
      • Belfast, Northern Ireland, United Kingdom
        • Research Site
      • Newry, Northern Ireland, United Kingdom
        • Research Site
      • Omagh, Northern Ireland, United Kingdom
        • Research Site

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

46 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects with end-stage renal failure aged 50-80 years, who have received regular haemodialysis treatment for at least 3 months

Exclusion Criteria:

  • Subjects will have no underlying condition that is expected to limit survival to less than 1 year and is also unrelated to end-stage renal disease (ESRD). Subjects should not have received a statin therapy within the past 6 months

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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: Rosuvastatin 10mg
Drug: 10mg Rosuvastatin
Placebo Comparator: Placebo
matching Placebo
Drug: Placebo

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
Time Frame
Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)
Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years

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
Time Frame
Number of Randomised Participants That Died From Any Cause.
Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause
Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Number of Randomised Participants That Died From Cardiovascular Cause
Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Number of Randomised Participants That Died From Non Cardiovascular Cause
Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death)
Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Number of Randomised Participants That Experienced a Procedure as a Result of Stenosis or Thrombosis of the Vascular Access (Arteriovenous (AV) Fistulas and Grafts Only) for Haemodialysis.
Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Number of Randomised Participants That Experienced a Coronary or Peripheral Revascularisation (Including Above Ankle Limb Amputations).
Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years

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.
AstraZeneca

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: AstraZeneca Crestor Medical Sciences Director, MD, AstraZeneca

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

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.
January 1, 2003

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.
October 1, 2008

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.
October 1, 2008

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).
October 16, 2005

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.
October 16, 2005

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.
October 18, 2005

Study Record Updates

Last Update Posted (Estimate)

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.
May 19, 2011

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.
May 17, 2011

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.
May 1, 2011

More Information

Terms related to this study

Keywords

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.
  • 4522IL/0096
  • D3562C00096

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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