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Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Bronchitis in Adult Patients

10. června 2026 aktualizováno: Materia Medica Holding

Multicenter, Double Blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Bronchitis in Adult Patients

The goal of this clinical trial is to learn if Raphamin works to treat acute bronchitis in adults. It will also learn about the efficacy and the safety of Raphamin. The main questions it aims to answer are:

Will treatment with Rafamine contribute to a faster resolution of acute bronchitis symptoms, reduce the severity of the disease, and prevent the development of complications requiring antibacterial therapy compared to placebo therapy? Researchers will compare Raphamin to a placebo (a look-alike substance that contains no drug) to see if Raphamin works to treat acute bronchitis.

Participants will:

Take Raphamin or a placebo for 5 days. On the first day of treatment 8 tablets of Raphamin or a placibo should be taken using the following regimen: 1 tablet every 30 minutes for the first 2 hours (5 tablets in total for 2 hours), then 1 more tablet 3 times at equal intervals during the same day. On day 2 and onwards, 1 tablet should be taken 3 times a day.

Face-to-face visits are planned in the trial: Visit 1 (Day 1), Visit 2 (Day 4±1), Visit 3 (Day 7±1), and a phone Visit 4 (day 14±1). The study uses an electronic patient diary (EPD) in which symptoms of acute bronchitis (cough, sputum, chest pain during coughing) are assessed daily.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

The design is a multi-center, double-blind, placebo-controlled, randomized parallel-group clinical trial.

The trial will include outpatients of both sexes aged 18 to 64 years with clinical manifestations of acute bronchitis (AB) with a duration of symptoms (productive cough + one or more symptoms: dry wheezing in the lungs, "discomfort" in the chest, shortness of breath, fever) of less than 72 hours. Patients will be enrolled during the period of seasonal incidence of acute respiratory viral infections (ARVI). After the patient signs the information sheet and informed consent form for participation in the clinical trial, the medical history will be collected, thermometry, pulse oximetry, objective examination, laboratory tests (complete blood count and blood biochemistry, quantification of C-reactive protein ) will be performed. Associated diseases and concomitant therapy are recorded. Before the start of therapy, a nasopharyngeal swab is taken for subsequent PCR test and verification of respiratory viruses.

If there are indications (detecting an increased heart rate of more than 100 bpm, tachypnea with a rate of more than 24 breaths per minute, or body temperature >38˚C, or auscultation of moist rales on the affected side during examination of the patient), a posteroanterior and lateral X-ray examination of the chest organs or CT of the chest organs are performed to exclude pneumonia. It is allowed to use data from X-Ray/CT examination of the patient obtained no later than 72 hours before their inclusion in the trial.

Based on complaints, physical and instrumental examination, chronic pathology of the bronchopulmonary system and acute infectious process with lesion of the pulmonary tissue are excluded. In the presence of characteristic clinical symptoms of acute lesion of the bronchial tree and data obtained during examination, this allows a diagnosis of acute bronchitis to be made. Prior to the start of therapy, a nasopharyngeal swab is taken for subsequent PCR test and verification of respiratory viruses.

The severity of AB symptoms is assessed using the Bronchitis Severity Scale (BSS), Appendix 1.

If a patient meets the inclusion criteria are does not meet the exclusion criteria at Visit 1 (Day 1), they will be randomized to one of two groups: patients in Group 1 will receive Raphamin according to the regimen for 5 days; patients in Group 2 will receive Placebo according to the Raphamin administration regimen for 5 days.

The trial uses an electronic patient diary (EPD) where the symptoms of acute bronchitis (cough, sputum, chest pain during coughing) are assessed daily, and the Integrative Medicine Outcome Scale (IMOS), Appendix 4 is completed. Additionally, any possible deterioration in the patient's clinical condition is recorded in the diary (if applicable, for safety assessment / recording of adverse events). The investigator provides instructions to the patient on completing the diary at Visit 1.

Face-to-face visits are planned in the trial: Visit 1 (Day 1), Visit 2 (Day 4±1), Visit 3 (Day 7±1), and a phone Visit 4 (day 14±1). Patients visit the physician, or the physician visits patients, at a medical center or at home. In case of deterioration in the patient's condition or at the physician's decision, an unscheduled visit may be conducted throughout the trial.

During Visits 1-3, the physician performs a physical examination, records vital signs (RR, HR, BP, body temperature), performs pulse oximetry, records the dynamics of disease symptoms (according to the BSS), completes the European Quality of Life Instrument (EQ-5D) (Appendix 3), records the administration of basic and concomitant medications. At Visits 2 and 3, the physician monitors the completion of the EPD. At Visit 3, compliance is assessed. At Visit 4 (telephone visit), the physician assesses safety, collects information about the patient's condition, the presence/absence of complications, the use of antibacterial drugs, and the presence/absence of patient's hospitalization.

During the trial, patients may receive baseline therapy as indicated: a mucolytic for tight productive cough (Lazolvan® MAX, 1 capsule of 75 mg once daily for tight productive cough), analgesics and antipyretics for hyperthermia above 38°C (ibuprofen and/or paracetamol), therapy for concomitant diseases, excluding medications specified in the "Prohibited concomitant therapy" section.

Typ studie

Intervenční

Zápis (Odhadovaný)

308

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Rusko
      • Aramil, Rusko, 624000
        • Nábor
        • Aramil City Hospital
        • Kontakt:
          • Maria Evsina, MD
        • Vrchní vyšetřovatel:
          • Maria Evsina, MD
      • Gatchina, Rusko, 188300
        • Nábor
        • Gatchina Clinical Interdistrict Hospital
        • Kontakt:
          • Asmik Asatryan, MD
        • Vrchní vyšetřovatel:
          • Asmik Asatryan, MD
      • Izhevsk, Rusko, 426063
        • Zatím nenabíráme
        • City Clinical Hospital No # 9 of the Ministry of Health of the Udmurt Republic
        • Kontakt:
          • Andrey Yezhov, Prof.
        • Vrchní vyšetřovatel:
          • Andrey Yezhov, Prof.
      • Kazan', Rusko, 420012
        • Nábor
        • Kazan State Medical University/Department of Infectious Diseases
        • Kontakt:
          • Irina Kravchenko, Prof.
        • Vrchní vyšetřovatel:
          • Irina Kravchenko, Prof.
      • Kazan', Rusko, 420012
        • Nábor
        • Kazan State Medical University/Department of Internal Medicine
        • Kontakt:
          • Rustem Khamitov, Prof.
        • Vrchní vyšetřovatel:
          • Rustem Khamitov, Prof.
      • Moscow, Rusko, 105094
        • Zatím nenabíráme
        • Main Military Clinical Hospital named after Academician N.N. Burdenko/Therapeutic department
        • Kontakt:
          • Andrey Zaitsev, Prof.
        • Vrchní vyšetřovatel:
          • Andrey Zaitsev, Prof.
      • Moscow, Rusko, 119991
        • Zatím nenabíráme
        • First Moscow State Medical University named after I.M. Sechenov/University Clinical Hospital # 4
        • Kontakt:
          • Mikhail Osadchuk, MD, PhD
        • Vrchní vyšetřovatel:
          • Mikhail Osadchuk, MD, PhD
      • Nizhny Novgorod, Rusko, 603155
        • Nábor
        • LLC "Persona Group of Companies"
        • Kontakt:
          • Natalia Eremina, MD, PhD
        • Vrchní vyšetřovatel:
          • Natalia Eremina, MD, PhD
      • Perm, Rusko, 614070
        • Nábor
        • LLC "Professorial Clinic"
        • Kontakt:
          • Svetlana Teplykh, MD, PhD
        • Vrchní vyšetřovatel:
          • Svetlana Teplykh, MD, PhD
      • Pyatigorsk, Rusko, 357502
        • Nábor
        • LLC "Ultrasound clinic 4D"
        • Kontakt:
          • Tatyana Rushnichenko, MD
        • Vrchní vyšetřovatel:
          • Tatyana Rushnichenko, MD
      • Rostov-on-Don, Rusko, 152155
        • Nábor
        • Rostov Central District Hospital
        • Kontakt:
          • Olga Zherebtsova, MD
        • Vrchní vyšetřovatel:
          • Olga Zherebtsova, MD
      • Saint Petersburg, Rusko, 194156
        • Nábor
        • LLC "Energy of Health"
        • Kontakt:
          • Natalia Egorova, MD
        • Vrchní vyšetřovatel:
          • Natalia Egorova, MD
      • Saint Petersburg, Rusko, 197376
        • Zatím nenabíráme
        • Institute of Experimental Medicine
        • Kontakt:
          • Svetlana Mosolova, MD
        • Vrchní vyšetřovatel:
          • Svetlana Mosolova Svetlana, MD
      • Saint Petersburg, Rusko, 199406
        • Nábor
        • LLC "Meili"
        • Kontakt:
          • Irina Nesterovich, MD, PhD
        • Vrchní vyšetřovatel:
          • Irina Nesterovich, MD, PhD
      • Saint Petersburg, Rusko, 194356
        • Nábor
        • LLC "Medical Clinic"
        • Kontakt:
          • Maxim Bushara, MD
        • Vrchní vyšetřovatel:
          • Maxim Bushara, MD
      • Saint Petersburg, Rusko, 199155
        • Nábor
        • City Polyclinic # 3
        • Kontakt:
          • Vera Panezhina, MD
        • Vrchní vyšetřovatel:
          • Vera Panezhina, MD
      • Saint Petersburg, Rusko, 199178
        • Nábor
        • City Polyclinic # 4
        • Kontakt:
          • Alexandra Rykova, MD
        • Vrchní vyšetřovatel:
          • Alexandra Rykova, MD
      • Saint Petersburg, Rusko, 191036
        • Nábor
        • St. Petersburg Research Institute of Phthisiopulmonology
        • Kontakt:
          • Yana Startseva, MD
        • Vrchní vyšetřovatel:
          • Yana Startseva, MD
      • Saint Petersburg, Rusko, 192071
        • Nábor
        • City Polyclinic # 44
        • Kontakt:
          • Ruslan Sardinov, MD, PhD
        • Vrchní vyšetřovatel:
          • Ruslan Sardinov, MD, PhD
      • Saint Petersburg, Rusko, 194354
        • Nábor
        • LLC "Medical Center "Reavita Med St. Petersburg"
        • Kontakt:
          • Veronica Popova, MD, PhD
        • Vrchní vyšetřovatel:
          • Veronica Popova, MD, PhD
      • Saint Petersburg, Rusko, 195427
        • Nábor
        • City Polyclinic # 112
        • Kontakt:
          • Elizaveta Antonova, MD
        • Vrchní vyšetřovatel:
          • Elizaveta Antonova, MD
      • Saint Petersburg, Rusko, 196158
        • Nábor
        • LLC "Starry Clinic"
        • Kontakt:
          • Dmitry Shkarbul, MD
        • Vrchní vyšetřovatel:
          • Dmitry Shkarbul, MD
      • Saint Petersburg, Rusko, 197110
        • Nábor
        • LLC "YAKUSI Clinic"
        • Kontakt:
          • Varvara Popova, MD, PhD
        • Vrchní vyšetřovatel:
          • Varvara Popova, MD, PhD
      • Saint Petersburg, Rusko, 197198
        • Nábor
        • City Polyclinic # 34
        • Kontakt:
          • Yulia Drozdova, MD
        • Vrchní vyšetřovatel:
          • Yulia Drozdova, MD
      • Saint Petersburg, Rusko, 199106
        • Nábor
        • Pokrovskaya City Hospital
        • Kontakt:
          • Oleg Khmelnitsky, MD, PhD
        • Vrchní vyšetřovatel:
          • Oleg Khmelnitsky, MD, PhD
      • Samara, Rusko, 443056
        • Nábor
        • Samara City Hospital # 4
        • Kontakt:
          • Elena Borodulina, Prof.
        • Vrchní vyšetřovatel:
          • Elena Borodulina, Prof.
      • Samara, Rusko, 443099
        • Nábor
        • Samara State Medical University/Department of Infectious Diseases with Epidemiology
        • Kontakt:
          • Dmitry Konstantinov, MD, PhD
        • Vrchní vyšetřovatel:
          • Dmitry Konstantinov, MD, PhD
      • Saratov, Rusko, 410012
        • Nábor
        • Saratov State Medical University named after V.I. Razumovsky/Department of Faculty Therapy
        • Kontakt:
          • Yuri Schwartz, Prof.
        • Vrchní vyšetřovatel:
          • Yuri Schwartz, Prof.
      • Smolensk, Rusko, 214019
        • Nábor
        • Smolensk State Medical University/Medical and Consultative Center "Academy of Health"
        • Kontakt:
          • Roman Kozlov, Prof.
        • Vrchní vyšetřovatel:
          • Roman Kozlov, Prof.
      • Stavropol, Rusko, 355000
        • Nábor
        • Scientific Medical Center of General Therapy and Pharmacology
        • Kontakt:
          • Olga Ukhanova, Prof.
        • Vrchní vyšetřovatel:
          • Olga Ukhanova, Prof.
      • Ulyanovsk, Rusko, 432063
        • Nábor
        • Ulyanovsk Regional Clinical Hospital
        • Kontakt:
          • Andrey Peskov, Prof.
        • Vrchní vyšetřovatel:
          • Andrey Peskov, Prof.
      • Voronezh, Rusko, 394066
        • Nábor
        • Voronezh Regional Clinical Hospital # 1/Pulmonology department
        • Kontakt:
          • Natalia Kostina, MD, PhD
        • Vrchní vyšetřovatel:
          • Natalia Kostina, MD, PhD
      • Yaroslavl, Rusko, 1150040
        • Nábor
        • LLC "Medical Center for Diagnostics and Prevention Plus"
        • Kontakt:
          • Ekaterina Melnikova, MD,PhD
        • Vrchní vyšetřovatel:
          • Ekaterina Melnikova, MD,PhD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  1. Male and female patients aged 18 to 64 years, inclusive.
  2. Confirmed diagnosis of acute bronchitis (AB) based on the presence of productive cough and one or more symptoms (wheezing in the lungs, chest "discomfort", shortness of breath, fever).
  3. The BSS score of at least 5 and no more than 15 points.
  4. Duration of AB symptoms does no more than 72 hours.
  5. Seasonal incidence of acute respiratory viral infections.
  6. Availability of a patient information sheet and an informed consent form for participation in the clinical trial signed by the patient.
  7. Patients who have agreed to use a reliable method of contraception during the study (for men and women of reproductive potential).

Exclusion Criteria:

  1. History of chronic obstructive pulmonary disease, chronic bronchitis, asthma, bronchiectasis, or pulmonary emphysema.
  2. Suspected pneumonia or bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring antibiotics, starting on the first day of illness.
  3. Suspected infiltrative pulmonary tuberculosis, pulmonary embolism, pulmonary infarction, drug-induced (toxic) pneumopathy, foreign body aspiration, sarcoidosis, pulmonary alveolar proteinosis, lipoid pneumonia, or atelectasis.
  4. History of immunopathological diseases: systemic vasculitis, lupus pneumonitis, allergic bronchopulmonary aspergillosis, obliterating bronchiolitis, idiopathic pulmonary fibrosis, eosinophilic pneumonia, bronchocentric granulomatosis.
  5. Chronic heart failure with functional classes III and IV (according to the classification of the New York Heart Association, 1964).
  6. Metabolic disorders (obesity grades 2-3).
  7. History of chronic kidney disease (classes C3-5 A3); liver failure (class C according to Child-Pugh); neurological conditions (neuromuscular, neurocognitive disorders, epilepsy); hemoglobinopathy.
  8. Primary and/or secondary immunodeficiency (HIV infection, administration of immunosuppressive drugs, etc.).
  9. Surgery of any localization within the last 3 months.
  10. Clinical symptoms of severe influenza/ARI requiring hospitalization .
  11. Acute respiratory failure.
  12. History/suspected oncological disease of any location (except for benign neoplasms).
  13. Exacerbation or decompensation of chronic diseases that affect the patient's ability to participate in the clinical trial, including diabetes mellitus.
  14. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
  15. Pregnancy, breastfeeding, and childbirth less than 3 months prior to study inclusion.
  16. Hypersensitivity to any component of the medications used in the treatment.
  17. Patients who have taken medications listed in the "Prohibited Concomitant Medication" section in the previous 1 month prior to study inclusion or who require medications prohibited for use in this study.
  18. Patients who, in the investigator's opinion, will not comply with study monitoring requirements or with the study drugs administration schedule.
  19. History of mental illness, alcoholism, or drug abuse that, in the investigator's opinion, will interfere with successful compliance with study procedures.
  20. Participation in other clinical trials within 3 months prior to study inclusion.
  21. The patient is a member of the center's research staff directly involved in the study and is an immediate family member of the investigator. Immediate family members are defined as spouses, parents, children, or siblings, regardless of whether they are biological or adopted.
  22. The patient is employed by NPF MATERIA MEDICA HOLDING LLC, i.e., is an employee of the company, a temporary contract worker, or a designated official responsible for the study, or is an immediate family member of one of these individuals..

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Raphamin

Per os bez jídla. Tabletu je třeba uchovávat v ústech, dokud se úplně nerozpustí.

1. den léčby by se mělo užít 8 tablet podle následujícího schématu: 1 tableta každých 30 minut po dobu prvních 2 hodin (celkem 5 tablet po dobu 2 hodin), poté 1 další tabletu 3x ve stejných intervalech během téhož dne. Od 2. dne se má užívat 1 tableta 3x denně. Délka léčby je 5 dní.
Lék: Raphamin
Orální podávání
Komparátor placeba: Placebo
Placebo s použitím dávkovacího režimu Raphamin.
Lék: Placebo
Ústní podání

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of patients with the BSS score of 4 points or less
Časové okno: On day 4
To evaluate and compare the proportion of patients with the Bronchitis Severity Scale (BSS) score of 4 points or less in two groups (Raphamin and Placebo) on day 4 of treatment.
On day 4

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in the total BSS score
Časové okno: 7 days
To assess and compare the change in the total BSS score in two groups (Raphamin and Placebo) compared to baseline over 7 days.
7 days
Proportion of patients with the BSS score of 4 points or less
Časové okno: On day 7
To evaluate and compare the proportion of patients with the BSS score of 4 points or less in two groups (Raphamin and Placebo) on observation day 7.
On day 7
Proportion of patients with a decrease in the BSS score by 5 points or more
Časové okno: On 4 and 7 days
To evaluate and compare the proportion of patients with a decrease in the BSS score by 5 points or more in two groups (Raphamin and Placebo) as compared to baseline on observation days 4 and 7.
On 4 and 7 days
Change in the severity of acute bronchitis symptoms
Časové okno: 14 days
To evaluate and compare the change in the severity of acute bronchitis symptoms (cough, sputum, chest pain during cough) in two groups (Raphamin and Placebo) based on the EPD data as compared to baseline throughout the entire period of treatment and follow-up (14 days).
14 days
Proportion of patients with no individual symptoms (cough, sputum, wheezing, chest pain during cough, shortness of breath) according to the BSS
Časové okno: On 4 and 7 days
To evaluate and compare the proportion of patients with no individual symptoms (cough, sputum, wheezing, chest pain during cough, shortness of breath) according to the BSS in two groups (Raphamin and Placebo) on observation days 4 and 7.
On 4 and 7 days
Time to effect of therapy according to the IMOS
Časové okno: 14 days
To evaluate and compare the time to effect of therapy according to the Integrative Medicine Outcome Scale (IMOS) in two groups (Raphamin and Placebo) based on the EPD data.
14 days
EQ-5D total score
Časové okno: On 4 and 7 days
To evaluate and compare the European Quality of Life Instrument (EQ-5D) total score in two groups (Raphamin and Placebo) on observation days 4 and 7 as compared to baseline.
On 4 and 7 days
Proportion of patients with worsening of bronchitis requiring systemic antibacterial therapy
Časové okno: 14 days
To evaluate and compare the proportion of patients with worsening of bronchitis requiring systemic antibacterial therapy in the Raphamin and Placebo groups.
14 days
Proportion of patients hospitalized due to worsening of acute bronchitis
Časové okno: 14 days
To evaluate and compare the proportion of patients hospitalized due to worsening of acute bronchitis in the Raphamin and Placebo groups.
14 days
Number of participants with AEs
Časové okno: 14 days
To evaluate and compare the presence and nature of adverse events (AE) in the Raphamin and Placebo groups during the therapy period. Based on medical records.
14 days
The intensity (severity) ofAEs
Časové okno: 14 days
To evaluate and compare the intensity (severity) of adverse events in the Raphamin and Placebo groups during the therapy period. Based on medical records.
14 days
Causal relationship of AEs to the sudy drug
Časové okno: 14 days
To evaluate and compare the relation to the study drug of adverse events in the Raphamin and Placebo groups during the therapy period. Based on medical records.
14 days
Outcome of AEs
Časové okno: 14 days
To evaluate and compare the outcome of adverse events in the Raphamin and Placebo groups during the therapy period. Based on medical records.
14 days
Changes in vital signs (Blood Pressure)
Časové okno: 14 days
Blood Pressure measured in mm Hg. Based on medical records.
14 days
Changes in vital signs (Heart Rate)
Časové okno: 14 days
Pulse Rate measured in beats per minute. Based on medical records.
14 days
Changes in vital signs (Breathing Rate)
Časové okno: 14 days
Respiratory Rate measured in breaths per minute. Based on medical records.
14 days

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Materia Medica Holding

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

9. prosince 2025

Primární dokončení (Odhadovaný)

31. prosince 2028

Dokončení studie (Odhadovaný)

31. prosince 2028

Termíny zápisu do studia

První předloženo

10. června 2026

První předloženo, které splnilo kritéria kontroly kvality

10. června 2026

První zveřejněno (Aktuální)

16. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

16. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. června 2026

Naposledy ověřeno

1. března 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • MMH-407-012

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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