Evaluation of Effectiveness of the Treatment After Repeated Administration of Klacid®SR

September 15, 2025 updated by: Abbott

Evaluation of Effectiveness of the Treatment After Repeated Administration of Klacid®SR in Patients With Upper Respiratory Infection, Exacerbation of Chronic Bronchitis and Mild Community-acquired Pneumonia in Common Clinical Practice in the Czech Republic

This post-marketing observational study (PMOS) will be conducted in a prospective, single-arm, single-country, multicenter format. The investigational sites will be consulting rooms of GPs (general practitioner), pneumologists and centers with experience in the treatment of patients with acute infections of trachea, bronchi, AECB (acute exacerbation of chronic bronchitis) and CAP (mild community-acquired pneumonia). Since this will be a post-marketing observational study, Klacid SR will be prescribed in usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. Objective: to describe the effectiveness of the treatment with repeated administration of Klacid SR in patients with acute tracheitis, acute tracheobronchitis or acute bronchitis; or in patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose administered within this study.

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.

Detailed Description

Follow-up of participants should enable three visits during this period. At the Screening Visit the decision for Klacid SR therapy in a dose of 500 -1000 mg once daily will be made. The Second Visit will occur 8 - 16 days after study initiation. The Last Visit will be a phone call to the participant after 30 days from the initiation of the treatment. Study visits will be defined as "V1" = Screening Visit, "V2" = Visit in which Klacid SR therapy will be terminated and "V3" = Phone call 30 days after initiation of Klacid SR therapy.

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.
Observational

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.
3130

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

  • Czechia
      • Blansko, Czechia, 678 01
        • Site Reference ID/Investigator# 37282
      • Blansko, Czechia, 678 01
        • Site Reference ID/Investigator# 37324
      • Boskovice, Czechia, 680 01
        • Site Reference ID/Investigator# 37424
      • Brandýs nad Labem, Czechia, 250 01
        • Site Reference ID/Investigator# 37329
      • Brno, Czechia, 602 00
        • Site Reference ID/Investigator# 37268
      • Brno, Czechia, 602 00
        • Site Reference ID/Investigator# 37299
      • Brno, Czechia, 602 00
        • Site Reference ID/Investigator# 37331
      • Brno, Czechia, 602 00
        • Site Reference ID/Investigator# 37396
      • Brno, Czechia, 602 00
        • Site Reference ID/Investigator# 37411
      • Brno, Czechia, 60200
        • Site Reference ID/Investigator# 37403
      • Brno, Czechia, 616 00
        • Site Reference ID/Investigator# 37380
      • Brno, Czechia, 636 00
        • Site Reference ID/Investigator# 37327
      • Bučovice, Czechia, 685 01
        • Site Reference ID/Investigator# 37429
      • Bučovice, Czechia, 685 01
        • Site Reference ID/Investigator# 37444
      • Buštěhrad, Czechia, 273 43
        • Site Reference ID/Investigator# 37433
      • Bílina, Czechia, 418 01
        • Site Reference ID/Investigator# 37381
      • Bílina, Czechia, 418 01
        • Site Reference ID/Investigator# 37391
      • Břeclav, Czechia, 690 02
        • Site Reference ID/Investigator# 37443
      • Cheb, Czechia, 350 03
        • Site Reference ID/Investigator# 37362
      • Cheb, Czechia, 35002
        • Site Reference ID/Investigator# 47286
      • Chrudim, Czechia, 537 01
        • Site Reference ID/Investigator# 37413
      • Děčín, Czechia, 405 01
        • Site Reference ID/Investigator# 37372
      • Děčín, Czechia, 40501
        • Site Reference ID/Investigator# 37394
      • Holešov, Czechia, 769 01
        • Site Reference ID/Investigator# 37263
      • Holešov, Czechia, 769 01
        • Site Reference ID/Investigator# 43230
      • Hradec Králové, Czechia, 500 02
        • Site Reference ID/Investigator# 26623
      • Hradec Králové, Czechia, 500 02
        • Site Reference ID/Investigator# 37270
      • Hradec Králové, Czechia, 500 02
        • Site Reference ID/Investigator# 37371
      • Hradec Králové, Czechia, 500 02
        • Site Reference ID/Investigator# 43225
      • Hranice, Czechia, 753 01
        • Site Reference ID/Investigator# 37367
      • Hrádek, Czechia, 338 42
        • Site Reference ID/Investigator# 37274
      • Hřebeč, Czechia, 273 45
        • Site Reference ID/Investigator# 37364
      • Jablonec nad Nisou, Czechia, 466 04
        • Site Reference ID/Investigator# 37404
      • Jablonec nad Nisou, Czechia, 468 01
        • Site Reference ID/Investigator# 47283
      • Jaroměř, Czechia, 551 02
        • Site Reference ID/Investigator# 43229
      • Jindřichův Hradec, Czechia, 377 01
        • Site Reference ID/Investigator# 37376
      • Kaplice, Czechia, 382 41
        • Site Reference ID/Investigator# 37290
      • Karlovy Vary, Czechia, 360 01
        • Site Reference ID/Investigator# 37369
      • Karlovy Vary, Czechia, 360 01
        • Site Reference ID/Investigator# 37445
      • Karlovy Vary, Czechia, 360 17
        • Site Reference ID/Investigator# 37363
      • Kladno, Czechia, 272 01
        • Site Reference ID/Investigator# 37283
      • Kolín, Czechia, 280 02
        • Site Reference ID/Investigator# 37382
      • Konice, Czechia, 798 52
        • Site Reference ID/Investigator# 37368
      • Konice, Czechia, 798 52
        • Site Reference ID/Investigator# 37415
      • Kralovice, Czechia, 331 41
        • Site Reference ID/Investigator# 37272
      • Kunovice, Czechia, 68604
        • Site Reference ID/Investigator# 42162
      • Kyjov, Czechia, 697 01
        • Site Reference ID/Investigator# 43224
      • Letohrad, Czechia, 561 51
        • Site Reference ID/Investigator# 37323
      • Liberec, Czechia, 460 01
        • Site Reference ID/Investigator# 37389
      • Litomyšl, Czechia, 570 01
        • Site Reference ID/Investigator# 37416
      • Litvínov, Czechia, 43542
        • Site Reference ID/Investigator# 37384
      • Mariánské Lázně, Czechia, 353 01
        • Site Reference ID/Investigator# 37428
      • Mohelnice, Czechia, 78985
        • Site Reference ID/Investigator# 43228
      • Mohelnice, Czechia, 78985
        • Site Reference ID/Investigator# 43233
      • Moravská Třebová, Czechia, 571 01
        • Site Reference ID/Investigator# 43227
      • Most, Czechia
        • Site Reference ID/Investigator# 47290
      • Mělník, Czechia, 276 01
        • Site Reference ID/Investigator# 37289
      • Městec Králové, Czechia, 289 03
        • Site Reference ID/Investigator# 37293
      • Neratovice, Czechia, 277 11
        • Site Reference ID/Investigator# 37297
      • Nový Bor, Czechia, 473 01
        • Site Reference ID/Investigator# 37397
      • Nový Jičín, Czechia, 741 01
        • Site Reference ID/Investigator# 37303
      • Nový Jičín, Czechia, 741 01
        • Site Reference ID/Investigator# 37400
      • Obříství, Czechia, 277 42
        • Site Reference ID/Investigator# 37399
      • Olomouc, Czechia, 772 00
        • Site Reference ID/Investigator# 37279
      • Olomouc, Czechia, 772 00
        • Site Reference ID/Investigator# 37280
      • Pardubice, Czechia, 530 03
        • Site Reference ID/Investigator# 37395
      • Pilsen, Czechia, 301 00
        • Site Reference ID/Investigator# 37271
      • Pilsen, Czechia, 304 11
        • Site Reference ID/Investigator# 37273
      • Pilsen, Czechia, 323 00
        • Site Reference ID/Investigator# 37423
      • Pilsen, Czechia, 326 00
        • Site Reference ID/Investigator# 37431
      • Planá, Czechia, 348 15
        • Site Reference ID/Investigator# 47284
      • Poděbrady, Czechia, 290 01
        • Site Reference ID/Investigator# 37325
      • Poděbrady, Czechia, 290 01
        • Site Reference ID/Investigator# 47282
      • Prague, Czechia, 100 00
        • Site Reference ID/Investigator# 37375
      • Prague, Czechia, 120 00
        • Site Reference ID/Investigator# 37398
      • Prague, Czechia, 130 00
        • Site Reference ID/Investigator# 37410
      • Prague, Czechia, 140 00
        • Site Reference ID/Investigator# 37387
      • Prague, Czechia, 140 00
        • Site Reference ID/Investigator# 37390
      • Prague, Czechia, 140 00
        • Site Reference ID/Investigator# 43232
      • Prague, Czechia, 140 00
        • Site Reference ID/Investigator# 43365
      • Prague, Czechia, 141 00
        • Site Reference ID/Investigator# 37288
      • Prague, Czechia, 141 00
        • Site Reference ID/Investigator# 37300
      • Prague, Czechia, 141 00
        • Site Reference ID/Investigator# 37301
      • Prague, Czechia, 141 00
        • Site Reference ID/Investigator# 37328
      • Prague, Czechia, 141 00
        • Site Reference ID/Investigator# 37330
      • Prague, Czechia, 141 00
        • Site Reference ID/Investigator# 37332
      • Prague, Czechia, 142 00
        • Site Reference ID/Investigator# 43236
      • Prague, Czechia, 149 00
        • Site Reference ID/Investigator# 37262
      • Prague, Czechia, 150 00
        • Site Reference ID/Investigator# 37295
      • Prague, Czechia, 158 00
        • Site Reference ID/Investigator# 37427
      • Prague, Czechia, 160 00
        • Site Reference ID/Investigator# 37275
      • Prague, Czechia, 163 00
        • Site Reference ID/Investigator# 37419
      • Prague, Czechia, 169 00
        • Site Reference ID/Investigator# 37438
      • Prague, Czechia, 181 00
        • Site Reference ID/Investigator# 37326
      • Prague, Czechia, 190 00
        • Site Reference ID/Investigator# 37414
      • Prague, Czechia, 190 00
        • Site Reference ID/Investigator# 47289
      • Prague, Czechia, 198 00
        • Site Reference ID/Investigator# 37291
      • Prague, Czechia, 198 00
        • Site Reference ID/Investigator# 37294
      • Prostějov, Czechia, 796 01
        • Site Reference ID/Investigator# 37437
      • Prostějov, Czechia, 796 04
        • Site Reference ID/Investigator# 37430
      • Příbor, Czechia, 742 58
        • Site Reference ID/Investigator# 37378
      • Příbor, Czechia, 742 58
        • Site Reference ID/Investigator# 37412
      • Příbram, Czechia, 261 01
        • Site Reference ID/Investigator# 37432
      • Příbram, Czechia, 261 95
        • Site Reference ID/Investigator# 37425
      • Rakovník, Czechia, 269 29
        • Site Reference ID/Investigator# 37442
      • Raspenava, Czechia, 464 01
        • Site Reference ID/Investigator# 37393
      • Rožnov pod Radhoštěm, Czechia, 756 61
        • Site Reference ID/Investigator# 37421
      • Sadová, Czechia, 612 00
        • Site Reference ID/Investigator# 37287
      • Tachov, Czechia, 347 42
        • Site Reference ID/Investigator# 37285
      • Teplice, Czechia, 415 01
        • Site Reference ID/Investigator# 37386
      • Týn, Czechia, 375 01
        • Site Reference ID/Investigator# 43366
      • Týn nad Vltavou, Czechia, 375 01
        • Site Reference ID/Investigator# 37265
      • Třeboň, Czechia, 379 01
        • Site Reference ID/Investigator# 43231
      • Třebíč, Czechia, 674 01
        • Site Reference ID/Investigator# 37264
      • Třebíč, Czechia, 674 01
        • Site Reference ID/Investigator# 37277
      • Třinec, Czechia, 739 61
        • Site Reference ID/Investigator# 37405
      • Uherské Hradiště, Czechia, 686 01
        • Site Reference ID/Investigator# 37434
      • Uherský Brod, Czechia, 688 01
        • Site Reference ID/Investigator# 37365
      • Velké Pavlovice, Czechia, 691 06
        • Site Reference ID/Investigator# 37284
      • Vlašim, Czechia, 258 01
        • Site Reference ID/Investigator# 37385
      • Zdar, Czechia, 591 01
        • Site Reference ID/Investigator# 37366
      • Zlín, Czechia, 762 75
        • Site Reference ID/Investigator# 43235
      • České Budějovice, Czechia, 370 01
        • Site Reference ID/Investigator# 37267
      • České Budějovice, Czechia, 370 01
        • Site Reference ID/Investigator# 37269
      • České Budějovice, Czechia, 370 01
        • Site Reference ID/Investigator# 37298
      • České Budějovice, Czechia, 370 01
        • Site Reference ID/Investigator# 37302
      • České Budějovice, Czechia, 370 05
        • Site Reference ID/Investigator# 37392
      • České Budějovice, Czechia, 370 87
        • Site Reference ID/Investigator# 37408
      • Čáslav, Czechia, 286 01
        • Site Reference ID/Investigator# 37374
      • Šlapanice, Czechia, 664 51
        • Site Reference ID/Investigator# 37406
      • Štětí, Czechia, 41108
        • Site Reference ID/Investigator# 37383
      • Šumperk, Czechia, 787 01
        • Site Reference ID/Investigator# 37278
      • Šumperk, Czechia, 78701
        • Site Reference ID/Investigator# 43223
      • Šumperk, Czechia, 78752
        • Site Reference ID/Investigator# 43234
      • Žamberk, Czechia, 56421
        • Site Reference ID/Investigator# 37322

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with: acute tracheitis, acute tracheobronchitis or acute bronchitis, acute exacerbation of chronic bronchitis, mild community-acquired pneumonia

Description

Inclusion Criteria:

  • Men, women at least 18 years old.
  • Patients treated with Klacid®SR between 6 weeks and 24 months prior to start of the PMOS.

  • Patients:

    • with acute tracheitis,
    • acute tracheobronchitis,
    • acute bronchitis,
    • mild community-acquired pneumonia or
    • acute exacerbation of chronic bronchitis

Exclusion Criteria:

  • Patients without previous administration of Klacid®SR and patients who used Klacid®SR less than 6 weeks ago or more than 24 months ago. The information about previous administration of Klacid®SR will be based on physician records or patients anamnesis.
  • Patients with known hypersensitivity to macrolide antibiotics
  • Patients with documented renal impairment (creatinine clearance under 30 ml/min).
  • Patients with documented liver parenchyma impairment (AST, ALT and GMT > 3x higher level in comparison with the norm)
  • Concomitant therapy with the following drugs: astemizole, cisapride, colchicine, pimozide, terfenadine and ergotamine or dihydroergotamine
  • Pregnancy
  • Breast feeding

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Respiratory Infections
Czech patients with acute tracheitis, acute tracheobronchitis or acute bronchitis; or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid®SR treatment 6 weeks prior to the next Klacid®SR dose or in intervals: 7-week - 3- month, 4- month - 12- month, 13- month - 24- month prior to the next Klacid®SR dose (next Klacid®SR dose = dose administered within this PMOS).

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
Disappearance or Significant Alleviation of Symptoms
Time Frame: Day 8 - 16
Overall therapeutic response, "yes" or "no" was determined by the physician based on subjective response regarding disappearance or significant alleviation of symptoms following treatment. The physician also considered objective findings such as auscultation and or chest X-ray results (if available) when determining overall therapeutic response.
Day 8 - 16
Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician)
Time Frame: Day 0, Day 8 - 16
Auscultation findings (abnormal breath sounds) were assessed at the initial visit (Day 0) and the second visit (Day 8 -16) by the physician. "Regression of chest X-ray findings" were not recorded as it is not part of routine clinical practice to confirm X-ray regression after the participant has clinically recovered from Community-Acquired Pneumonia (CAP).
Day 0, Day 8 - 16

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
Body Temperature
Time Frame: Day 0, Day 8-16
Number of participants in which body temperature was increased (temperature above 37 degrees Celsius).
Day 0, Day 8-16
Bacteriological Investigation (if Available)
Time Frame: Day 0
The type of agent present in the infection was assessed using bacteriological investigation. Occurrence of the most common agents was reported. Participants may have had more than one pathogen present. Test results were not available prior to enrollment but were reported during the study.
Day 0
Cough and Its Character
Time Frame: Day 0, Day 8-16
Number of participants in which cough was present, and if present, type of cough (irritating, productive, both or not reported)
Day 0, Day 8-16
Dyspnea and Its Type
Time Frame: Day 0, Day 8-16
Presence of dyspnea (difficulty breathing) and type of dyspnea (exertional, resting, both, or not reported).
Day 0, Day 8-16
Auscultation
Time Frame: Day 0, Day 8-16
Participants with abnormal auscultation findings (abnormal breath sounds) and type of findings (wheezing, crackles, both, or not reported).
Day 0, Day 8-16
Chest X-ray in Case of Community-Acquired Pneumonia (CAP)
Time Frame: Day 0
Number of participants in which X-ray findings were suggestive of pneumonia. In participants where the physician suspected CAP, a chest X-ray was performed and reviewed to determine whether findings were indicative of pneumonia.
Day 0
Study Drug Given as the First, Second or Third Antimicrobial Treatment
Time Frame: Day 0
Number of participants who received Klacid SR as the first, second or third (further) antimicrobial agent.
Day 0
Compliance
Time Frame: Day 8 - 16
Number of participants who took their medication according to the prescribed regimen (dose and duration) during the study.
Day 8 - 16
Termination of Treatment Due to Noncompliance
Time Frame: Day 8 - 16
Number of participants who discontinued Klacid SR treatment early due to noncompliance with the recommended study medication regimen.
Day 8 - 16

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.
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: Adam Hloska, M.D., Abbott Laboratories, s.r.o. (Czech Republic)

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, 2010

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.
July 1, 2010

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.
July 1, 2010

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).
May 6, 2010

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.
May 25, 2010

First Posted (Estimated)

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.
May 26, 2010

Study Record Updates

Last Update Posted (Estimated)

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.
October 6, 2025

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.
September 15, 2025

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.
September 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.
  • P12-109

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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