Trial Condition(s):
Refractory and/or unexplained chronic cough
Clinical study to evaluate the efficacy and safety of three different doses of BAY1817080 compared to placebo in patients with chronic cough (PAGANINI)
Bayer Identifier:
20393
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
Researchers in this study want to find the optimal therapeutic dose of drug BAY1817080 for patients with long-standing cough with or without clear causes (refractory and/or unexplained chronic cough, RUCC). Study drug BAY1817080 is a new drug under development for the treatment of long-standing cough. It blocks proteins that are expressed by the airway sensory nerves which are oversensitive in patients with long-standing cough. This prevents the urge to cough. Researchers also want to learn the safety of the study drug and how well it works in reducing the cough frequency, severity and urge-to-cough.
Participants in this study will receive either the study drug or placebo (a placebo looks like the test drug but does not have any medicine in it) tablets twice daily for 12 weeks. Observation for each participant will last about 18 weeks in total. Participants will be asked to wear a digital device to record the cough and to complete questionnaires every day to document the symptoms. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.
Inclusion Criteria
- Adults ≥ 18 years of age at the time of signing the informed consent. - A cough that has lasted for at least 12 months (unresponsive to treatment options) with a diagnosis of refractory chronic cough and/or idiopathic (unexplained) chronic cough. - Persistent cough for at least the last 8 weeks before screening. - Women of childbearing potential must agree to use acceptable effective or highly effective birth control methods during the study and for at least 30 days after the last dose. - Capable of giving signed informed consent.
Exclusion Criteria
- Smoking history within the last 12 months before screening (all forms of smoking, including e-cigarettes, cannabis and others), and any former smoker with more than 20 pack-years. - Ongoing or previous exposure to inhalational toxic fumes (e.g., ammonia, chlorine, nitrogen dioxide, phosgene and sulfur dioxide) within the last 12 months before screening. - Respiratory tract infection within 4 weeks before screening. - History of chronic bronchitis. - Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening visit. - Positive SARS-CoV-2 virus RNA and/or serology IgG tests at screening visit.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations Akdeniz Universitesi Tip Fakultesi Hastanesi Antalya, Turkey, 07058 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Gent GENT, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dr. MARTINOT Jean-Benoît Erpent, Belgium, 5101 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHU de Liège LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sureyyapasa Gogus Hasalikleri. ve Gogus Cerrahisi EAH Maltepe, Turkey, 34844 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitari Germans Trias i Pujol Badalona, Spain, 08916 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mersin Universitesi Tip Fakultesi Mersin, Turkey, 33343 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi Istanbul, Turkey, 34098 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Voronezh Regional Clinical Hospital #1 Voronezh, Russia, 394066 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City Consultative and Diagnostic Center #1 St. Petersburg, Russia, 194354 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City Clinical Hospital #4 Samara Samara, Russia, 453056 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City Clinical Hospital n.a. D.D. Pletnev Moscow, Russia, 105077 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LLC "Medical Center "SibNovoMed"" Novosibirsk, Russia, 630005 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LLC Astarta St. Petersburg, Russia, 199226 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Region Clinical Emergency Hospital n.a. M.A.Podgorbunskogo Kemerovo, Russia, 650000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations VZW Emmaus MECHELEN, Belgium, 2800 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela, Spain, 15706 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fundación CIDEA CABA, Argentina, C1121ABE | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigaciones en Patologías Respiratorias San Miguel de Tucumán, Argentina | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigación en Alergias y Enfermedades Respiratorias-INAER CABA, Argentina, C1425 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Médico Dra. De Salvo - Clinical Research Center Buenos Aires, Argentina, C1426ABP | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Instituto Ave Pulmo Mar del Plata, Argentina | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Respiratorio Quilmes Quilmes, Argentina | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro de Investigaciones Clínicas CABA, Argentina, C1018DES | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chesapeake Clinical Research, Inc. White Marsh, United States, 21162 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pharmaceutical Research & Consulting, Inc. Dallas, United States, 75231 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations California Allergy & Asthma Medical Group & Research Center Los Angeles, United States, 90025 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bellingham Asthma, Allergy & Immunology Clinic Bellingham, United States, 98225 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Montana Medical Research, Inc Missoula, United States, 59808 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Minnesota Lung Center Edina, United States, 55435 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ege Universitesi Tip Fakultesi Izmir, Turkey, 35100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U.I. Verona Verona, Italy, 37126 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Careggi Firenze, Italy, 50134 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Lodi Lodi, Italy, 26845 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Ospedale Sacro Cuore Don Calabria Verona, Italy, 37024 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Hochschule Hannover (MHH) Hannover, Germany, 30625 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ballenberger, Freytag, Wenisch Neu-Isenburg, Germany, 63263 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pneumologicum im Südstadt Forum Hannover, Germany, 30173 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Praxis f. Lungen- und Bronchialheilkunde, Berlin, Germany, 10717 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Priv.-Doz. Dr. med. Christian Gessner Leipzig, Germany, 04357 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zentrum f. ambulante pneumologische Forschung Marburg GbR Marburg, Germany, 35037 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinikum Konstanz Konstanz, Germany, 78464 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Isala ZWOLLE, Netherlands, 8025 AB | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Catharina Ziekenhuis EINDHOVEN, Netherlands, 5623 EJ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dawon s.r.o. Praha 4, Czech Republic, 14800 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ordinace pro TBC a respiracni nemoci, s.r.o. Olomouc, Czech Republic, 772 00 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Plicní stredisko Teplice, s.r.o. Teplice, Czech Republic, 415 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MUDr Otakar Hokynar - Plicni ambulance Kralupy nad Vltavou, Czech Republic, 278 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MUDr. Milan Sklenar Varnsdorf, Czech Republic, 407 47 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Taiwan University Hospital Taipei, Taiwan, China, 100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chang Gung Memorial Hospital Keelung Keelung, Taiwan, China, 20401 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taichung Veterans General Hospital Taichung, Taiwan, China, 40705 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taipei Medical University Hospital Taipei, Taiwan, China, 110 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Far Eastern Memorial Hospital New Taipei City, Taiwan, China, 220 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ostrowieckie Centrum Medyczne Sp. Cyw. A.O-C. K.C. Ostrowiec Swietokrzyski, Poland, 27-400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations KLIMED Marek Klimkiewicz Bychawa, Poland, 23-100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centrum Alergologii Sp. z o.o. Lublin, Poland, 20-552 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centrum Medyczne Lucyna Andrzej Dymek Strzelce Opolskie, Poland, 47-100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centrum Medycyny Oddechowej Mroz Spolka Jawna Bialystok, Poland, 15-044 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Castle Hill Hospital Cottingham, United Kingdom, HU16 5JQ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations King's College Hospital - NHS Foundation Trust London, United Kingdom, SE5 9RS | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Hospital of South Manchester Manchester, United Kingdom, M23 9LT | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations North Tyneside General Hospital North Shields, United Kingdom, NE29 8NH | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations West Walk Surgery Bristol, United Kingdom, BS37 4AX | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vanderbilt University Medical School Nashville, United States, 37212-1610 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHU de Toulouse - Hôpital Larrey TOULOUSE Cedex 9, France, 31059 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cochin - Paris PARIS, France, 75674 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Burlington Lung Clinic (BLC) Clinical Research Burlington, Canada, L7N 3V2 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinique de pneumologie et du sommeil de Lanaudière (CPSL) St-Charles-Borromée, Canada, J6E 2B4 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Western Respiratory Trial Specialists Spearwood, Australia, 6163 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Holdsworth House Medical Practice Sydney, Australia, 2010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Maroubra Medical Centre Maroubra, Australia, 2035 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Macquarie University Hospital Macquarie University, Australia, 2109 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Adelaide Hospital Adelaide, Australia, 5000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations D.Kenessey A Hospital Balassagyarmat, Hungary, 2660 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Erzsebet Gondozohaz Godollo, Hungary, 2100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Da Vinci Maganklinika Pecs, Hungary, 7635 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Farmakontroll Bt. Szazhalombatta, Hungary, 2440 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations EKBC, Uj Szent Janos Korhaz es Szakrendelo Budapest, Hungary, 1122 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Plucna ambulancia s.r.o. Poprad, Slovakia, 058 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AlergoImunocentrum, s.r.o. Kezmarok, Slovakia, 060 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations INSPIRO, s.r.o. Humenne, Slovakia, 066 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ALIAN s.r.o. Bardejov, Slovakia, 085 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ambulancia klin. imunologie a alergologie, ANA JJ, s.r.o. Topolcany, Slovakia, 955 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nagoya City University Hospital Nagoya, Japan, 467-8602 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Japan community health care organization Kanazawa Hospital Kanazawa, Japan, 920-8610 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Idaimae Minami Yojo Sapporo, Japan, 064-0804 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Matsusaka Municipal Hospital Matsusaka, Japan, 515-8544 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Komatsu Municipal Hospital Komatsu, Japan, 923-8560 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Occupational and Environmental Health Kitakyushu, Japan, 807-8556 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saiseikai Yokohamashi Nanbu Hospital Yokohama, Japan, 234-8503 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yokohama City Minato Red Cross Hospital Yokohama, Japan, 231-8682 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fukushima Medical University Hospital Fukushima, Japan, 960-1295 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hamamatsu Rosai Hospital Hamamatsu, Japan, 430-8525 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tokyo Shinagawa Hospital Shinagawa-ku, Japan, 140-8522 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Fukui Hospital Yoshida, Japan, 910-1193 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Florida Pediatrics Largo, United States, 33778 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Randomized, double-blind, parallel group, Phase 2b dose-finding, efficacy and safety study of 12-week twice daily oral administration of BAY 1817080 compared to placebo in the treatment of refractory and/or unexplained chronic cough (RUCC)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- Change from baseline in 24-hour cough count after 12 weeks of interventionMeasured by cough recording digital wearable monitoring device. btw = between geo = geometric Per protocol set (PPS): All participants randomly assigned to study intervention who did not have validity findings affecting efficacy. Participants were analyzed according to the intervention they actually received. If a participant received different interventions during the study, he/she was excluded from the PPS. The main reasons for excluding the participants from the PPS were that there was no valid post-baseline measurement available due to an intercurrent event (15 participants , 4.8%) or that the participant had used prohibited concomitant medication (9 participants , 2.9%).Timeframe: From baseline up to 12 weeks
Secondary Outcome
- Percentage of participants with a ≥30% reduction from baseline in 24-hour cough count after 12 weeks of interventionMeasured by cough recording digital wearable monitoring device PPS: All participants randomly assigned to study intervention who did not have validity findings affecting efficacy. Participants were analyzed according to the intervention they actually received. If a participant received different interventions during the study, he/she was excluded from the PPS. The main reasons for excluding the participants from the PPS were that there was no valid post-baseline measurement available due to an intercurrent event (15 participants , 4.8%) or that the participant had used prohibited concomitant medication (9 participants , 2.9%).Timeframe: From baseline up to 12 weeks
- Change from baseline in 24-hour cough count after 2, 4, and 8 weeks of interventionMeasured by cough recording digital wearable monitoring device btw = between geo = geometric PPS: All participants randomly assigned to study intervention who did not have validity findings affecting efficacy. Participants were analyzed according to the intervention they actually received. If a participant received different interventions during the study, he/she was excluded from the PPS. The main reasons for excluding the participants from the PPS were that there was no valid post-baseline measurement available due to an intercurrent event (15 participants , 4.8%) or that the participant had used prohibited concomitant medication (9 participants , 2.9%).Timeframe: From baseline up to 2 weeks, 4 weeks and 8 weeks
- Change from baseline in awake cough frequency per hour after 2, 4, 8 and 12 weeks of interventionMeasured by cough recording digital wearable monitoring device btw = between geo = geometric PPS: All participants randomly assigned to study intervention who did not have validity findings affecting efficacy. Participants were analyzed according to the intervention they actually received. If a participant received different interventions during the study, he/she was excluded from the PPS. The main reasons for excluding the participants from the PPS were that there was no valid post-baseline measurement available due to an intercurrent event (15 participants , 4.8%) or that the participant had used prohibited concomitant medication (9 participants , 2.9%).Timeframe: From baseline up to 2 weeks, 4 weeks, 8 weeks and 12 weeks
- Change from baseline in cough related quality of life after 12 weeks of interventionMeasured by Leicester Cough Questionnaire [LCQ] PPS: All participants randomly assigned to study intervention who did not have validity findings affecting efficacy. Participants were analyzed according to the intervention they actually received. If a participant received different interventions during the study, he/she was excluded from the PPS. The main reasons for excluding the participants from the PPS were that there was no valid post-baseline measurement available due to an intercurrent event (15 participants , 4.8%) or that the participant had used prohibited concomitant medication (9 participants , 2.9%).Timeframe: From baseline up to 12 weeks
- Change from baseline in cough severity after 12 weeks of interventionMeasured by Cough Severity Visual Analogue Scale [VAS] PPS: All participants randomly assigned to study intervention who did not have validity findings affecting efficacy. Participants were analyzed according to the intervention they actually received. If a participant received different interventions during the study, he/she was excluded from the PPS. The main reasons for excluding the participants from the PPS were that there was no valid post-baseline measurement available due to an intercurrent event (15 participants , 4.8%) or that the participant had used prohibited concomitant medication (9 participants , 2.9%).Timeframe: From baseline up to 12 weeks
- Percentage of participants with a ≥30 scale units reduction from baseline after 12 weeks of interventionMeasured by cough Severity VAS PPS: All participants randomly assigned to study intervention who did not have validity findings affecting efficacy. Participants were analyzed according to the intervention they actually received. If a participant received different interventions during the study, he/she was excluded from the PPS. The main reasons for excluding the participants from the PPS were that there was no valid post-baseline measurement available due to an intercurrent event (15 participants , 4.8%) or that the participant had used prohibited concomitant medication (9 participants , 2.9%).Timeframe: From baseline up to 12 weeks
- Percentage of participants with a ≥1.3-point increase from baseline after 12 weeks of interventionMeasured with LCQ Total Score PPS: All participants randomly assigned to study intervention who did not have validity findings affecting efficacy. Participants were analyzed according to the intervention they actually received. If a participant received different interventions during the study, he/she was excluded from the PPS. The main reasons for excluding the participants from the PPS were that there was no valid post-baseline measurement available due to an intercurrent event (15 participants , 4.8%) or that the participant had used prohibited concomitant medication (9 participants , 2.9%).Timeframe: From baseline up to 12 weeks
- Number of participants with treatment-emergent adverse events (TEAEs) and associated severitySafety analysis set (SAF): All participants randomly assigned to study intervention and who took at least one tablet of study intervention. Subjects were analyzed according to the intervention they actually received.Timeframe: From the start of study intervention administration until 14 days after the last study medication intake
Additional Information
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