This prospective multicenter registry of the clinical practice of European gastroenterologists on the management of Helicobacter pylori infection and its treatment is supported by the European Helicobacter & Microbiota Study Group and the Asociación Española de Gastroenterología.
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(only countries with highest number of patients included)
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Fadieienko GD, Shvets OV, Moreira L, Nyssen OP, Mégraud F, O’Morain C, Gisbert JP, Gridnyev OE. Current trends in the treatment of H. pylori infection in Ukraine: results of the European Registry on Helicobacter pylori Management (Hp-EuReg). J Modern Gastroenterology. 2022 Sep;29:5-13. DOI: 10.30978/MG-2022-3-5
Nyssen OP, Vaira D, Pérez Aísa A, Rodrigo L, Castro-Fernandez M, Jonaitis L, Tepes B, Vologzhanina L, Caldas M, Lanas A, Lucendo AJ, Bujanda L, Ortuño J, Barrio, Huguet JM, Voynovan I, Perez Lasala J, Silkanovna Sarsenbaeva A, Fernandez-Salazar L, Molina-Infante J, Brglez Jurecic N, Areia M, Gasbarrini A, Kupčinskas J, Bordin D, Marcos-Pinto R, Lerang F, Leja M, Buzas GM, Niv Y, Rokkas T, Phull P, Smith S, Shvets O, Venerito M, Milivojevic V, Simsek I, Lamy V, Bytzer P, Boyanova L, Kunovský L, Beglinger C, Doulberis M, Marlicz W, Goldis A, Tonkić A, Capelle L, Puig I, Megraud F, O’ Morain C, Gisbert JP, on behalf of the Hp-EuReg Investigators. Empirical second-line therapy in 5,000 patients of the European Registry on Helicobacter pylori Management (Hp-EuReg). Clin Gastroenterol Hepatol. 2022 Oct;20(10):2243-2257. DOI: 10.1016/j.cgh.2021.12.025 PMID: 34954341
Nyssen OP, Moreira L, García-Morales N, Cano-Català A, Puig I, Megraud F, O'Morain C, Gisbert JP. European Registry on Helicobacter pylori Management (Hp-EuReg): Most relevant results for clinical practice. Front. Gastroenterol. 2022 Aug 17;1:965982. DOI: 10.3389/fgstr.2022.965982
Fernández-Salazar L, Campillo A, Rodrigo L, Pérez-Aisa Á, González-Santiago JM, Segarra Ortega X, Denkovski M, Brglez Jurecic N, Bujanda L, Gómez Rodríguez BJ, Ortuño J, Georgopoulos S, Jonaitis L, Puig I, Nyssen OP, Mégraud F, O'Morain C, Gisbert JP. Effectiveness and Safety of High-Dose Dual Therapy: Results of the European Registry on the Management of Helicobacter pylori Infection (Hp-EuReg). J Clin Med. 2022 Jun 20;11(12):3544. DOI: 10.3390/jcm11123544 - PMID: 35743627
Nyssen OP, Vaira D, Saracino IM, Fiorini G, Caldas M, Bujanda L, Pellicano R, Keco-Huerga A, Pabón-Carrasco M, Oblitas Susanibar E, Di Leo A, Losurdo G, Pérez Aísa A, Gasbarrini A, Boltin D, Smith S, Phull P, Rokkas T, Lamaraque D, Cano-Català A, Puig I, Mégraud F, O'Morain C, Gisbert JP. Experience with Rifabutin-Containing Therapy in 500 Patients from the European Registry on Helicobacter pylori Managament (Hp-EuReg). J Clin Med. 2022 Mar 16;11(6):1658. DOI: 10.3390/jcm11061658. PMID: 35329984
Rokkas T, Georgopoulos S, Michopoulos S, Ntouli V, Liatsos C, Puig I, Nyssen OP, Mégraud F, O'Morain C, Gisbert JP, On behalf of the Hp-EuReg Investigators. Assessment of First-Line Eradication Treatment in Greece: Data from the European Registry on Helicobacter pylori Management (Hp-EuReg). Ann Gastroenterol. Jan-Feb 2022;35(1):42-47. DOI: 10.20524/aog.2021.0670. PMID: 34987287.
Nyssen OP, Vaira D, Tepes B, Kupcinskas L, Bordin D, Pérez-Aisa A, Gasbarrini A, Castro-Fernández M, Bujanda L, Garre A, Lucendo A, Vologzhanina L, Brglez Jurecic N, Rodrigo-Sáez L, Huguet Malavés JM, Voynovan I, Perez Lasala J, Mata Romero P, Vujasinovic M, Abdulkhakov R, Barrio J, Fernandez-Salazar L, Mégraud F, O’Morain C, Gisbert JP. Room for improvement in the treatment of Helicobacter pylori infection: lessons from the European Registry on H. pylori management (Hp-EuReg) J Clin Gastroenterol. 2022 Feb 1;56(2):e98-e108. DOI: 10.1097/MCG.0000000000001482. PMID: 33405435
Bujanda L, Nyssen OP, Vaira D, Saracino IM, Fiorini G, Lerang F, Georgopoulos S, Tepes B, Heluwaert F, Gasbarrini A, Rokkas T, Bordin D, Smith S, Lamy V, Caldas M, Resina E, Muñoz R, Cosme Á, Puig I, Megraud F, O'Morain C, Gisbert JP. Antibiotic resistance prevalence and trends in patients infected with Helicobacter pylori in the period 2013-2020: results of the European Registry on H. pylori Management (Hp-EuReg). Antibiotics (Basel). 2021 Sep 1;10(9):1058. DOI: 10.3390/antibiotics10091058. PMID: 34572640.
Caldas M, Pérez-Aisa Á, Tepes B, Keco-Huerga A, Bujanda L, Lucendo AJ, Rodrigo L, Vaira D, Fernández-Salazar L, Huguet JM, Pérez-Lasala J, Jurecic NB, Fadeenko G, Barrio J, Areia M, Ortuño J, Pellicano R, Leja M, Molina-Infante J, Bogomolov P, Alekseenko S, Domínguez-Cajal M, Gómez-Camarero J, Ntouli V, Martínez-Domínguez SJ, Ruiz-Zorrilla R, Núñez O, Sarsenbaeva AS, Almela P, Phull P, Espada M, Puig I, Nyssen OP, Mégraud F, O'Morain C, Gisbert JP, On Behalf Of The Hp-EuReg Investigators. The Role of Statins on Helicobacter pylori Eradication: Results from the European Registry on the Management of H. pylori (Hp-EuReg). Antibiotics (Basel). 2021 Aug 11;10(8):965. DOI: 10.3390/antibiotics10080965. PMID: 34439015
Tepes B, Brglez Jurecic N, Tepes K, Espada Sanchez M, Nyssen OP, O'Morain C, Mégraud F, Gisbert JP. Helicobacter pylori Eradication Rates in Slovenia in the Period from 2017 to 2019: Data from the European Registry on H. pylori Management. Dig Dis. 2021;39(4):318-324. DOI: 10.1159/000512506. PMID: 33099549
Jonaitis P, Kupcinskas J, Nyssen OP, Puig I, Gisbert JP, Jonaitis L. Evaluation of the Effectiveness of Helicobacter pylori Eradication Regimens in Lithuania during the Years 2013–2020: Data from the European Registry on Helicobacter pylori Management (Hp-EuReg). Medicina 2021; 57(7),642. www.mdpi.com/1648-9144/57/7/642
Nyssen OP, Perez-Aisa A, Tepes B, Castro-Fernandez M, Kupcinskas J, Jonaitis L, Bujanda L, Lucendo A, Brglez Jurecic N, Perez-Lasala J, Shvets O, Fadeenko G, Huguet JM, Kikec Z, Bordin D, Voynovan I, Leja M, Machado JC, Areia M, Fernandez-Salazar L, Rodrigo L, Alekseenko S, Barrio J, Ortuño J, Perona M, Vologzhanina L, Mata Romero P, Zaytsev O, Rokkas T, Georgopoulos S, Pellicano R, Buzas GM, Modolell I, Gomez Rodriguez BJ, Simsek I, Simsek C, Roldan Lafuente M, Ilchishina T, Gomez Camarero J, Dominguez-Cajal M, Ntouli V, Nikolaevna Dekhnich N, Phull P, Nuñez O, Lerang F, Venerito M, Heluwaert F, Tonkic A, Caldas M, Puig I, Megraud F, O'Morain C, Gisbert JP. Adverse Event Profile During the Treatment of Helicobacter pylori: A Real-World Experience of 22,000 Patients From the European Registry on H. pylori Management (Hp-EuReg). Am J Gastroenterol.2021 Jun 1;116(6):1220-1229. DOI: 10.14309/ajg.0000000000001246. PMID: 33840725
Nyssen OP, Perez Aisa A, Castro Fernandez M, Pellicano R, Huguet JM, Rodrigo L, Ortuño J, Gomez Rodriguez BJ, M Pinto RM, Areia M, Perona M, Nuñez O, Romano M, Gravina AG, Pozzati L, Fernandez Bermejo M, Venerito M, Malfertheiner P, Fernanadez Salazar L, Gasbarrini A, Vaira D, Puig I, Megraud F, O'Morain C, Gisbert JP, Hp-EuReg investigators. European Registry on Helicobacter pylori Management (Hp-EuReg): Single capsule bismuth quadruple therapy is effective in real-world clinical practice. United European Gastroenterol J 2021; 9(1):38-46. DOI: 10.1177/2050640620972615. PMID: 33176617.
Boltin D, Beniashvili Z, Lahat A, Hirsch J, Nyssen OP, Mégraud F, O'Morain C, Gisbert JP, Niv Y. European Registry on Helicobacter pylori management (Hp-EuReg): First-line Therapy in Israel. Isr Med Assoc J 2021; 23(1):38-42. PMID: 33443341.
Nyssen OP, Bordin D, Tepes B, Pérez-Aisa Á, Vaira D, Caldas M, Bujanda L, Castro-Fernandez M, Lerang F, Leja M, Rodrigo L, Rokkas T, Kupcinskas L, Pérez-Lasala J, Jonaitis L, Shvets O, Gasbarrini A, Simsek H, Axon ATR, Buzás G, Machado JC, Niv Y, Boyanova L, Goldis A, Lamy V, Tonkic A, Przytulski K, Beglinger C, Venerito M, Bytzer P, Capelle L, Milosavljević T, Milivojevic V, Veijola L, Molina-Infante J, Vologzhanina L, Fadeenko G, Ariño I, Fiorini G, Garre A, Garrido J, F Pérez C, Puig I, Heluwaert F, Megraud F, O'Morain C, Gisbert JP. European Registry on Helicobacter pylori management (Hp-EuReg): patterns and trends in first-line empirical eradication prescription and outcomes of 5 years and 21 533 patients. Gut 2021 Jan;70(1):40-54. DOI:10.1136/gutjnl-2020-321372. Epub 2020 Sep 21. PMID: 32958544.
Abdulkhakov SR, Bordin DS, Abdulkhakov RA, Safina DD, Gizdatullina AR, Gimadieva LZ, Safina GM, Ziyatdinov AI, Maturina AM, Nyssen OP, Megraud F, O'Morain C, Gisbert JP. European Registry on the management of Helicobacter pylori infection: features of diagnosis and treatment in Kazan. Ter Arkh 2020; 92(8):52-59. DOI: 10.26442/00403660.2020.08.000758 PMID: 33346462.
Caldas M, Pérez-Aisa Á, Castro-Fernández M, Bujanda L, Lucendo AJ, Rodrigo L, Huguet JM, Pérez-Lasala J, Molina-Infante J, Barrio J, Fernández-Salazar L, Lanas Á, Perona M, Domínguez-Cajal M, Ortuño J, Gómez-Rodríguez BJ, Almela P, Botargués JM, Núñez Ó, Modolell I, Gómez J, Ruiz-Zorrilla R, De la Coba C, Huerta A, Iyo E, Pozzati L, Antón R, Barenys M, Angueira T, Fernández-Bermejo M, Campillo A, Alcedo J, Pajares-Villaroya R, Mego M, Bermejo F, Dominguez-Jiménez JL, Titó L, Fernández N, Pabón-Carrasco M, Cosme Á, Mata-Romero P, Alcaide N, Ariño I, Di Maira T, Garre A, Puig I, Nyssen OP, Megraud F, O’Morain C, Gisbert JP. European Registry on Helicobacter pylori Management: Effectiveness of First and Second-Line Treatment in Spain. Antibiotics 2020; 10: E13. DOI: 10.3390/antibiotics10010013. PMID: 33375717.
Nyssen OP, Perez-Aisa A, Rodrigo L, Castro M, Mata Romero P, Ortuño J, Barrio J, Huguet JM, Modollel I, Alcaide N, Lucendo A, Calvet X, Perona M, Gomez B, Gomez Rodriguez BJ, Varela P, Jimenez-Moreno M, Dominguez-Cajal M, Pozzati L, Burgos D, Bujanda L, Hinojosa J, Molina-Infante J, Di Maira T, Ferrer L, Fernández-Salazar L, Figuerola A, Tito L, de la Coba C, Gomez-Camarero J, Fernandez N, Caldas M, Garre A, Resina E, Puig I, O'Morain C, Megraud F, Gisbert JP. Bismuth quadruple regimen with tetracycline or doxycycline versus three-in-one single capsule as third-line rescue therapy for Helicobacter pylori infection: Spanish data of the European Helicobacter pylori Registry (Hp-EuReg). Helicobacter. 2020 Oct;25(5):e12722. DOI: 10.1111/hel.12722. Epub 2020 Jul 13. PMID: 32656898.
Bordin DS, Voynovan IN, Embutnieks YV, Nyssen OP, Megraud F, O Morain C, Perez-Gisbert J. [European registry on Helicobacter pylori management (Hp-EuReg) as a tool to evaluate and improve clinical practice in Moscow]. Ter Arkh. 2020 Apr 27;92(2):12-18. Russian. DOI: 10.26442/00403660.2020.02.000567. PMID: 32598712.
Nyssen OP, Pérez-Aisa Á, Tepes B, Rodrigo-Sáez L, Romero PM, Lucendo A, Castro-Fernández M, Phull P, Barrio J, Bujanda L, Ortuño J, Areia M, Brglez Jurecic N, Huguet JM, Alcaide N, Voynovan I, María Botargues Bote J, Modolell I, Pérez Lasala J, Ariño I, Jonaitis L, Dominguez-Cajal M, Buzas G, Lerang F, Perona M, Bordin D, Axon T, Gasbarrini A, Marcos Pinto R, Niv Y, Kupcinskas L, Tonkic A, Leja M, Rokkas T, Boyanova L, Shvets O, Venerito M, Bytzer P, Goldis A, Simsek I, Lamy V, Przytulski K, Kunovský L, Capelle L, Milosavljevic T, Caldas M, Garre A, Mégraud F, O'Morain C, Gisbert JP; Hp-EuReg Investigators. Helicobacter pylori first-line and rescue treatments in patients allergic to penicillin: Experience from the European Registry on H pylori management (Hp-EuReg). Helicobacter. 2020 Jun;25(3):e12686. DOI: 10.1111/hel.12686. Epub 2020 Mar 16. PMID: 32173974.
Buzás GM, Nyssen OP, Mégraud F, O'Morain C, Gisbert JP. Páneurópai regiszter: a Helicobacter pylori-fertőzés kezelése. Ferencvárosi adatok, 2013–2019 [Pan-European Registry on Helicobacter pylori management. Results from Ferencváros, Budapest, 2013-2019]. Orv Hetil. 2019 Nov;160(47):1856-1863. Hungarian. DOI: 10.1556/650.2019.31553. PMID: 31736344.
McNicholl AG, O'Morain CA, Megraud F, Gisbert JP; As Scientific Committee of the Hp-Eureg on Behalf of the National Coordinators. Protocol of the European Registry on the management of Helicobacter pylori infection (Hp-EuReg). Helicobacter. 2019 Oct;24(5):e12630. DOI: 10.1111/hel.12630. Epub 2019 Jul 8. PMID: 31282060.
McNicholl AG, Bordin DS, Lucendo A, Fadeenko G, Fernandez MC, Voynovan I, Zakharova NV, Sarsenbaeva AS, Bujanda L, Perez-Aisa Á, Vologzhanina L, Zaytsev O, Ilchishina T, Coba C, Lasala JP, Alekseenko S, Modolell I, Molina-Infante J, Ruiz-Zorrilla Lopez R, Alonso-Galan H, Moreno NF, Hinojosa J, Santaella I, Varela P, Gonzalez-Cordero PL, Barrio J, Dominguez-Jimenez JL, Nuñez O, Alcedo J, Nyssen OP, Caldas M, Donday MG, Shvetz O, Megraud F, O'Morain C, Gisbert JP. Combination of Bismuth and Standard Triple Therapy Eradicates Helicobacter pylori Infection in More than 90% of Patients. Clin Gastroenterol Hepatol. 2020 Jan;18(1):89-98. DOI:10.1016/j.cgh.2019.03.048. Epub 2019 Apr 10. PMID: 30978536.
Bordin DS, Embutnieks YV, Vologzhanina LG, Ilchishina TA, Voynovan IN, Sarsenbaeva AS, Zaitsev OV, Alekseenko SA, Abdulkhakov RA, Dehnich NN, Osipenko MF, Livzan MA, Tsukanov VV, Burkov SG, Bakulina NV, Plotnikova EY, Tarasova LV, Maev IV, Kucheryavyi YA, Baryshnikova NV, Butov MA, Kolbasnikov SV, Pakhomova AL, Zhestkova TV, Baranovsky AY, Abdulhakov SR, Ageeva EA, Lyalyukova EA, Vasyutin AV, Golubev NN, Savilova IV, Morkovkina LV, Kononova AG, Megraud F, O'Morain C, Ramas M, Nyssen OP, McNicholl AG, Gisbert JP. [European registry Helicobacter pylori (Hp-EuReg): how has clinical practice changed in Russia from 2013 to 2018 years]. Ter Arkh. 2019 Feb 15;91(2):16-24. Russian. DOI: 10.26442/00403660.2019.02.000156. PMID: 32598623.
Bordin DS, Embutnieks YV, Vologzhanina LG, Il'chishina TA, Voinovan IN, Sarsenbaeva AS, Alekseenko SA, Zaitsev OV, Abdulkhakov RA, Osipenko MF, Livzan MA, Tsukanov VV, Burkov SG, Bakulina NV, Dekhnich NN, Tarasova LV, Plotnikova EY, Maev IV, Kucheryavyi YA, Baryshnikova NV, Butov MA, Kolbasnikov SV, Pakhomova AL, Zhestkova TV, Baranovskii AY, Abdulkhakov SR, Ageeva EA, Lyalyukova EA, Vasyutin AV, Golubev NN, Savilova IV, Morkovkina LV, Kononova AG, Megraud F, O'Morain C, Ramas M, Nyssen OP, McNicholl AG, Gisbert JP. European Registry on the management of Helicobacter pylori infection (Hp-EuReg): analysis of 2360 patients receiving first-line therapy in Russia. Ter Arkh. 2018 Feb 15;90(2):35-42. DOI: 10.26442/terarkh201890235-42. PMID: 30701770.
Tepes B, Kastelic M, Vujasinovic M, Lampic P, Seruga M, Jurecic NB, Nyssen OP, Donday MG, O'Morain C, Megraud F, McNicholl AG, Gisbert JP. Helicobacter Pylori Treatment Results in Slovenia in the Period 2013-2015 as a Part of European Registry on Helicobacter Pylori Management. Radiol Oncol. 2017 Dec 7;52(1):1-6. DOI: 10.1515/raon-2017-0055. PMID: 29520199; PMCID: PMC5839075.
Bordin DS, Yanova OB, Abdulkhakov RA, Tsukanov VV, Livzan MA, Burkov SG, Zakharova NV, Plotnikova EY, Osipenko MF, Tarasova LV, Maev IV, Kucheryavyi YA, Butov MA, Sablin OA, Kolbasnikov SV, Voinovan IN, Abdulkhakov SR, Vasyutin AV, Lyalyukova EA, Golubev NN, Savilova IV, Grigoryeva LV, Kononova AG, O'Morain C, Ramas M, Mcnicholl AG, Gisbert JP. [European Registry on the management of Helicobacter pylori infection (Hp-EuReg protocol): The first results of Russian centers]. Ter Arkh. 2016;88(2):33-38. Russian. DOI: 10.17116/terarkh201688233-38. PMID: 27030181.
Gisbert JP, Romano M, Gravina AG, Solís-Muñoz P, Bermejo F, Molina-Infante J, Castro-Fernández M, Ortuño J, Lucendo AJ, Herranz M, Modolell I, Del Castillo F, Gómez J, Barrio J, Velayos B, Gómez B, Domínguez JL, Miranda A, Martorano M, Algaba A, Pabón M, Angueira T, Fernández-Salazar L, Federico A, Marín AC, McNicholl AG. Helicobacter pylori second-line rescue therapy with levofloxacin- and bismuth-containing quadruple therapy, after failure of standard triple or non-bismuth quadruple treatments. Aliment Pharmacol Ther. 2015 Apr;41(8):768-75. DOI: 10.1111/apt.13128. Epub 2015 Feb 23. PMID: 25703120
Molina-Infante J, Lucendo AJ, Angueira T, Rodriguez-Tellez M, Perez-Aisa A, Balboa A, Barrio J, Martin-Noguerol E, Gomez-Rodriguez BJ, Botargues-Bote JM, Gomez-Camarero J, Huerta A, Modolell I, Ariño I, Herranz-Bachiller MT, Bermejo F, McNicholl AG, O'Morain C, Gisbert JP; European Registry on H. pylori management (Hp‐EuReg). Optimised empiric triple and concomitant therapy for Helicobacter pylori eradication in clinical practice: the OPTRICON study. Aliment Pharmacol Ther. 2015 Mar;41(6):581-9. DOI: 10.1111/apt.13069. Epub 2015 Jan 14. PMID: 25776067.
Patterns and H. pylori treatment effectiveness in Croatia
Prescriptions and effect of H. pylori antibiotic resistance on eradication treatments in Norway
Current trends in the management of H. pylori infection in Ukraine
The Azerbaijan history: diagnosis and treatment for H. pylori infection
H. pylori treatment prescriptions in Latvia: gastroenterologist versus general practitioners
Effectiveness of empirical first-line therapy in Russia from 2013 to 2021
Current trends in the management of H. pylori infection in Serbia
Effectiveness of First and Second-Line Empirical Treatment in Italy
Prescriptions, effectiveness and safety of H. pylori eradication regimens in the elderly
Patterns and relevance of compliance with eradication treatment in Europe
Patterns, effectiveness and safety of proton-pump-inhibitor prescription for H. pylori eradication in Europe
Patterns, effectiveness and safety of antibiotic prescription for H. pylori eradication in Europe
Role of bismuth in H. pylori eradication: effectiveness and safety
H. pylori diagnostic tests used in Europe
Role of probiotics in H. pylori eradication: effectiveness and safety
Bismuth quadruple three-in-one single capsule: 3 or 4 times daily?
Third to sixth-line rescue therapies for H. pylori infection in Europe
Influence on antibiotic resistance on efficacy of H. pylori eradication therapy
The Standard Operating Procedure (SOP) of the Hp-EuReg is intended to ensure the correct pathway for participating, recruiting patients, consulting and evaluating data, preparing studies and disseminating the project results.
By agreeing to participate in the study, investigators commit to the Scientific Committee and the other investigators, taking an active part in patient inclusion, promoting participation with other gastroenterologists or centres that may become involved, and disseminating the project to encourage active patient recruitment.
The SOP is available at https://redcap.aegastro.es/redcap_v12.3.2/FileRepository/index.php?pid=345, only accessible with individual investigators' REDCap credentials.
PMID | DOI
Helicobacter pylori selectively infects the human stomach, being the most prevalent chronic infection in the world. H pylori presence causes chronic gastritis in 100% of infected patients and is the major cause of relevant diseases such as atrophic gastritis, peptic ulcer disease, and gastric cancer; it is for this reason that from a public health standpoint, it is considered a high-impact pathogen, responsible of a significant morbidity and mortality. Nowadays, there are consensus and clinical guidelines regarding the infection management at a European level and in most of European countries, but no data have shown the level of implementation of these recommendations. The high costs that this infection carries both socially and to the health system require the continuous and systematic assessment of the diagnostic and treatment strategies, as well as the accessibility to diagnostic methods and most efficient drugs.
To register the diagnosis, management strategies, and treatment of H pylori-infected adult patients in the Digestive Services outpatient clinics throughout Europe.
Noninterventionist prospective multicentre international Registry promoted by the European Helicobacter and Microbiota Study Group. National Coordinators will select recruiting gastroenterologists in their country that will register the H pylori-related routine clinical practice consultations they receive in an electronic case report form (e-CRF) provided by AEG-REDCap. Variables retrieved will include clinical, diagnostic, treatment, eradication confirmation, and outcome data. The database will allow researchers to perform specific subanalyses after approval by the Scientific Committee of the study.
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