{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T04:13:34Z","timestamp":1772165614945,"version":"3.50.1"},"reference-count":35,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2019,12,31]],"date-time":"2019-12-31T00:00:00Z","timestamp":1577750400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2019,12,31]],"date-time":"2019-12-31T00:00:00Z","timestamp":1577750400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Gastroenterol"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The aim of this study was to investigate the efficacy and safety of the novel complex drug, consisting of released-active form of antibodies to S-100 protein, tumor necrosis factor-\u03b1 and histamine, (Kolofort) under outpatient conditions in patients with functional dyspepsia (FD), irritable bowel syndrome (IBS), and FD-IBS overlap.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The subjects of the observational noninterventional retrospective program were the data of 14,362 outpatient records of patients with diagnosed FD, IBS, and\/or overlap, who were observed by gastroenterologists from November 01, 2017, through March 30, 2018, who received the drug Kolofort in monotherapy for 12\u2009weeks, 2 tablets twice a day. To assess the presence and severity of symptoms of functional gastrointestinal disorders (FGID), the \u201c7*7\u201d questionnaire developed by a working group from the Russian Gastroenterological Association was used. The evaluated parameters included the proportion of patients: who had a 50% or more reduction in the total score; who have switched to the less severe category of the condition; who have switched to the \u201chealthy\u201d or \u201cborderline ill\u201d severity categories; and the change in the score in domains 1\u20137.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The final efficacy analysis included data from 9254 patients. A decrease in the total score by 50% or more was observed in 80.45% of patients with FD, 79.02% of patients with IBS, and in 83% of patients with both IBS and FD. Switch to a lower severity category of the condition at the end of therapy was noted in 93.35% of patients with FD, in 93.80% of cases in patients with IBS, and in 96.17% of cases in patients with a combination of IBS and FD. A total of 94 adverse events (AEs) were reported in 80 patients (0.65%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The COMFORT program has demonstrated the positive effect of treatment in the majority of patients with IBS and FD and their combination in real clinical practice.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12876-019-1143-5","type":"journal-article","created":{"date-parts":[[2019,12,31]],"date-time":"2019-12-31T10:02:51Z","timestamp":1577786571000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":18,"title":["Pathogenetic approach to the treatment of functional disorders of the gastrointestinal tract and their intersection: results of the Russian observation retrospective program COMFORT"],"prefix":"10.1186","volume":"20","author":[{"given":"Vladimir T.","family":"Ivashkin","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elena A.","family":"Poluektova","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexey B.","family":"Glazunov","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mikhail A.","family":"Putilovskiy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Oleg I.","family":"Epstein","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2019,12,31]]},"reference":[{"issue":"6","key":"1143_CR1","doi-asserted-by":"publisher","first-page":"1393-1407.e5","DOI":"10.1053\/j.gastro.2016.02.031","volume":"150","author":"Brian E. Lacy","year":"2016","unstructured":"Lacy BE, Mearin F, Chang L, Chey W D, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016;150(6):1393\u2013407.e5.","journal-title":"Gastroenterology"},{"issue":"2","key":"1143_CR2","doi-asserted-by":"crossref","first-page":"101","DOI":"10.22416\/1382-4376-2016-26-2-101-104","volume":"26","author":"VT Ivashkin","year":"2016","unstructured":"Ivashkin VT, Mayev IV, Sheptulin AA, Alekseyeva OP, Baranskaya YK, Ivashkin KV, Kalinin AV, Korochanskaya NV, Kucheryavy YA, Lapina TL, Plotnikova YY, Poluektova YA, Simanenkov VI, Storonova OA, Tkachyov AV, Shifrin OS, Tarasova LV, Khlynov IB. The resolution of advisory council \u00abhow to improve treatment results functional dyspepsia and irritable bowel syndrome\u00bb? Russ J Gastroenterol Hepatol Coloproctol. 2016;26(2):101\u20134.","journal-title":"Russ J Gastroenterol Hepatol Coloproctol"},{"issue":"4","key":"1143_CR3","doi-asserted-by":"publisher","first-page":"253","DOI":"10.1159\/000362405","volume":"89","author":"K Trinkley","year":"2014","unstructured":"Trinkley K, Nahata M. Medication management of irritable bowel syndrome. Digestion. 2014;89(4):253\u201367.","journal-title":"Digestion"},{"issue":"9","key":"1143_CR4","first-page":"550","volume":"13","author":"M Camilleri","year":"2017","unstructured":"Camilleri M. Medical therapies in the pipeline for irritable bowel syndrome. Gastroenterol Hepatol (N Y). 2017;13(9):550\u20132.","journal-title":"Gastroenterol Hepatol (N Y)"},{"issue":"9","key":"1143_CR5","doi-asserted-by":"publisher","first-page":"2455","DOI":"10.1007\/s10620-017-4598-7","volume":"62","author":"M Pimentel","year":"2017","unstructured":"Pimentel M, Cash BD, Lembo A, Wolf RA, Israel RJ, Schoenfeld P. Repeat Rifaximin for irritable bowel syndrome: no clinically significant changes in stool microbial antibiotic sensitivity. Dig Dis Sci. 2017;62(9):2455\u201363.","journal-title":"Dig Dis Sci"},{"issue":"9","key":"1143_CR6","doi-asserted-by":"publisher","first-page":"1553","DOI":"10.1111\/jgh.13756","volume":"32","author":"YJ Choi","year":"2017","unstructured":"Choi YJ, et al. Overlap between irritable bowel syndrome and functional dyspepsia including subtype analyses. J Gastroenterol Hepatol. 2017;32(9):1553\u201361.","journal-title":"J Gastroenterol Hepatol"},{"issue":"4","key":"1143_CR7","doi-asserted-by":"publisher","first-page":"447","DOI":"10.5056\/jnm14080","volume":"20","author":"Y Fujiwara","year":"2014","unstructured":"Fujiwara Y, Tetsuo A. Overlap in patients with dyspepsia\/functional dyspepsia. J Neurogastroenterol Motil. 2014;20(4):447\u201357.","journal-title":"J Neurogastroenterol Motil"},{"issue":"6","key":"1143_CR8","doi-asserted-by":"publisher","first-page":"1152","DOI":"10.1111\/j.1572-0241.2004.30040.x","volume":"99","author":"M Corsetti","year":"2004","unstructured":"Corsetti M, Caenepeel P, Fischler B, Janssens J, Tack J. Impact of coexisting irritable bowel syndrome on symptoms and pathophysiological mechanisms in functional dyspepsia. Am J Gastroenterol. 2004;99(6):1152\u20139.","journal-title":"Am J Gastroenterol"},{"issue":"4","key":"1143_CR9","doi-asserted-by":"publisher","first-page":"568","DOI":"10.4103\/0976-3147.169802","volume":"6","author":"SK Padhy","year":"2015","unstructured":"Padhy SK, Sahoo S, Mahajan S, Sinha S. Irritable bowel syndrome: is it \u201cirritable brain\u201d or \u201cirritable bowel\u201d? J Neurosci Rural Pract. 2015;6(4):568\u201377.","journal-title":"J Neurosci Rural Pract"},{"issue":"3","key":"1143_CR10","doi-asserted-by":"publisher","first-page":"182","DOI":"10.1016\/j.anr.2014.07.001","volume":"8","author":"SH Park","year":"2014","unstructured":"Park SH, Han KS, Kang CB. Relaxation therapy for irritable bowel syndrome: a systematic review. Asian Nurs Res. 2014;8(3):182\u201392.","journal-title":"Asian Nurs Res"},{"issue":"1","key":"1143_CR11","doi-asserted-by":"publisher","first-page":"4","DOI":"10.1186\/2049-9256-2-4","volume":"2","author":"Mihaela Fadgyas-Stanculete","year":"2014","unstructured":"Fadgyas-Stanculete M, Buga AM, Popa-Wagner A, Dumitrascu DL. The relationship between irritable bowel syndrome and psychiatric disorders: from molecular changes to clinical manifestations. J Mol Psychiatry. 2014;2(1):4.","journal-title":"Journal of Molecular Psychiatry"},{"issue":"4","key":"1143_CR12","doi-asserted-by":"publisher","first-page":"555","DOI":"10.5056\/jnm16166","volume":"23","author":"Y Kawoos","year":"2017","unstructured":"Kawoos Y, Wani ZA, Kadla SA, Shah IA, Hussain A, Dar MM, Margoob MA, Sideeq K. Psychiatric co-morbidity in patients with irritable bowel syndrome at a tertiary care center in Northern India. J Neurogastroenterol Motil. 2017;23(4):555\u201360.","journal-title":"J Neurogastroenterol Motil"},{"issue":"1","key":"1143_CR13","first-page":"44","volume":"14","author":"EA Mayer","year":"2018","unstructured":"Mayer EA. The role of gut-brain interactions in influencing of symptoms of IBS. Gastroenterol.Hepatol. (N.Y.). 2018;14(1):44\u20136.","journal-title":"Gastroenterol.Hepatol. (N.Y.)"},{"issue":"11","key":"1143_CR14","doi-asserted-by":"publisher","first-page":"1745","DOI":"10.1016\/j.cgh.2018.04.034","volume":"16","author":"D Pohl","year":"2018","unstructured":"Pohl D, Oudenhove L, T\u00f6rnblom H, Nev\u00e9 B, Tack J, Simr\u00e9n M. Functional Dyspepsia and Severity of Psychologic Symptoms Associate With Postprandial Symptoms in Patients With Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2018;16(11):1745\u20131753.e1.","journal-title":"Clin Gastroenterol Hepatol"},{"issue":"3","key":"1143_CR15","doi-asserted-by":"publisher","first-page":"385","DOI":"10.4103\/IJPM.IJPM_113_17","volume":"60","author":"SR Patel","year":"2017","unstructured":"Patel SR, Singh A, Misra V, Misra SP, Dwivedi M, Trivedi P. Levels of interleukins 2, 6, 8, and 10 in patients with irritable bowel syndrome. Indian J Pathol Microbiol. 2017;60(3):385\u20139.","journal-title":"Indian J Pathol Microbiol"},{"issue":"5","key":"1143_CR16","doi-asserted-by":"publisher","first-page":"631","DOI":"10.1016\/j.clinre.2015.12.013","volume":"40","author":"S Seyedmirzaee","year":"2016","unstructured":"Seyedmirzaee S, Hayatbakhsh MM, Ahmadi B, Baniasadi N, Bagheri Rafsanjani AM, Nikpoor AR, Mohammadi M. Serum immune biomarkers in irritable bowel syndrome. Clin Res Hepatol Gastroenterol. 2016;40(5):631\u20137.","journal-title":"Clin Res Hepatol Gastroenterol"},{"issue":"13","key":"1143_CR17","first-page":"222","volume":"115","author":"A Madisch","year":"2018","unstructured":"Madisch A, Andresen V, Enck P, Labenz J, Frieling T, Schemann M. The diagnosis and treatment of functional dyspepsia. Deutsches Arzteblatt Int. 2018;115(13):222\u201332.","journal-title":"Deutsches Arzteblatt Int"},{"key":"1143_CR18","doi-asserted-by":"publisher","first-page":"1677","DOI":"10.1111\/nmo.12421","volume":"26","author":"M Camilleri","year":"2014","unstructured":"Camilleri M, Shin A, Busciglio I, Carlson P, Acosta A, Bharucha AE, Burton D, Lamsam J, Lueke A, Donato LJ, et al. Validating biomarkers of treatable mechanisms in irritable bowel syndrome. Neurogastroenterol Motil. 2014;26:1677\u201385.","journal-title":"Neurogastroenterol Motil"},{"issue":"2","key":"1143_CR19","first-page":"92","volume":"24","author":"VT Ivashkin","year":"2014","unstructured":"Ivashkin VT, Sheligyn YA, Baranskaya EK, et al. Clinical guidelines for irritable bowel syndrom treatment of the Russian Society of Coloproctology and the Russian gastroenterological association. Ross z Gastroenterol Gepatol Koloproktol. 2014;24(2):92\u2013101.","journal-title":"Ross z Gastroenterol Gepatol Koloproktol"},{"key":"1143_CR20","doi-asserted-by":"publisher","first-page":"480","DOI":"10.1007\/s10620-018-5343-6","volume":"64","author":"M von Wulffen","year":"2019","unstructured":"von Wulffen M, Talley NJ, Hammer J, McMaster J, Rich G, Shah A, Koloski N, Kendall BJ, Jones M, Holtmann G. Overlap of irritable bowel syndrome and functional dyspepsia in the clinical setting: prevalence and risk factors. Dig Dis Sci. 2019;64:480.","journal-title":"Dig Dis Sci"},{"key":"1143_CR21","doi-asserted-by":"publisher","first-page":"175628481880559","DOI":"10.1177\/1756284818805597","volume":"11","author":"CJ Black","year":"2018","unstructured":"Black CJ, Houghton LA, Ford AC. Insights into the evaluation and management of dyspepsia: recent developments and new guidelines. Ther Adv Gastroenterol. 2018;11:1756284818805597.","journal-title":"Ther Adv Gastroenterol"},{"issue":"44","key":"1143_CR22","first-page":"S.25","volume":"4","author":"IA Jertuzun","year":"2012","unstructured":"Jertuzun IA, Zueva EP, Krylova SG, Efimova LA, Dugina JL, Jepshtejn OI. Jeksperimental'noe izuchenie \u00abKoloforta\u00bb \u2013 novogo preparata dlja lechenija sindroma razdrazhennogo kishechnika i drugih funkcional'nyh zabolevanij zheludochno-kishechnogo trakta. [Experimental study of preparation Kolofort \u2013 a novel drug for treatment of irritable bowel syndrome and other functional gastrointestinal disorders]. Vestnik VolgGMU. 2012;4(44):S.25\u20137 Russian.","journal-title":"Vestnik VolgGMU"},{"issue":"Suppl","key":"1143_CR23","first-page":"43","volume":"01","author":"EB Avalueva","year":"2014","unstructured":"Avalueva EB, Adasheva TV, Babaeva AR, Burdina EG, Kireeva NV, Lenskaja LG, Osadchuk MA, Pahomova IG, Popova LI, Tkachenko EI, Uspenskij JP, Shvarc JG, Myslivec AA, Andrianova EN. Jeffektivnost\u2019 i bezopasnost\u2019 primenenija Koloforta pri sindrome razdrazhennogo kishechnika: itogi mnogocentrovogo dvojnogo slepogo placebo-kontroliruemogo randomizirovannogo klinicheskogo issledovanija [Efficacy and safety of preparation Kolofort in treatment of irritable bowel syndrome:results of multicentral double blind placebo controlled clinical trial]. Consilium Medicum Gastrojenterologija. 2014;01(Suppl):43\u201350 Russian.","journal-title":"Consilium Medicum Gastrojenterologija"},{"issue":"6","key":"1143_CR24","doi-asserted-by":"publisher","first-page":"1042","DOI":"10.1111\/jgh.14546","volume":"34","author":"V Ivashkin","year":"2019","unstructured":"Ivashkin V, Sheptulin A, Shifrin O, Poluektova E, Pavlov C, Ivashkin K, Drozdova A, Lyashenko O, Korolev A. Clinical validation of the \u201c7 \u00d7 7\u201d questionnaire for patients with functional gastrointestinal disorders. J Gastroenterol Hepatol. 2019;34(6):1042\u20138.","journal-title":"J Gastroenterol Hepatol"},{"issue":"Suppl 1","key":"1143_CR25","doi-asserted-by":"publisher","first-page":"69","DOI":"10.1111\/bcp.12127","volume":"76","author":"A Neubert","year":"2013","unstructured":"Neubert A, Dormann H, Prokosch HU, B\u00fcrkle T, Rascher W, Sojer R, Brune K, Criegee-Rieck M. E-pharmacovigilance: development and implementation of a computable knowledge base to identify adverse drug reactions. Br J Clin Pharmacol. 2013;76(Suppl 1):69\u201377.","journal-title":"Br J Clin Pharmacol"},{"key":"1143_CR26","doi-asserted-by":"publisher","first-page":"13","DOI":"10.2174\/1573397112666151231110521","volume":"12","author":"MD Cashman","year":"2016","unstructured":"Cashman MD, Martin DK, Dhillon S, Puli SR. Irritable bowel syndrome: a clinical review. Curr Rheumatol Rev. 2016;12:13\u201326.","journal-title":"Curr Rheumatol Rev"},{"key":"1143_CR27","doi-asserted-by":"publisher","first-page":"16014","DOI":"10.1038\/nrdp.2016.14","volume":"2","author":"P Enck","year":"2016","unstructured":"Enck P, Aziz Q, Barbara G, Farmer AD, Fukudo S, Mayer EA, Niesler B, Quigley EM, Rajili\u0107-Stojanovi\u0107 M, Schemann M, Schwille-Kiuntke J, Simren M, Zipfel S, Spiller RC. Irritable bowel syndrome epidemiology, pathophysiology, diagnosis, and treatment. Nat Rev Dis Primers. 2016;2:16014.","journal-title":"Nat Rev Dis Primers"},{"issue":"Suppl 1","key":"1143_CR28","doi-asserted-by":"publisher","first-page":"25","DOI":"10.1159\/000485410","volume":"35","author":"P Malfertheiner","year":"2017","unstructured":"Malfertheiner P. STW 5 (Iberogast) therapy in gastrointestinal functional disorders. Dig Dis. 2017;35(Suppl 1):25\u20139.","journal-title":"Dig Dis"},{"key":"1143_CR29","doi-asserted-by":"publisher","first-page":"117","DOI":"10.4236\/ym.2017.12012","volume":"1","author":"F Chen","year":"2017","unstructured":"Chen F. Management of Overlap Syndrome between functional dyspepsia and irritable bowel syndrome by Western and traditional Chinese medicine. Yangtze Med. 2017;1:117\u201326.","journal-title":"Yangtze Med"},{"key":"1143_CR30","doi-asserted-by":"publisher","first-page":"1229","DOI":"10.1111\/j.1572-0241.2007.01740.x","volume":"103","author":"AC Ford","year":"2008","unstructured":"Ford AC, Forman D, Bailey AG, Axon AT, Moayyedi P. Irritable bowel syndrome: a 10-yr natural history of symptoms and factors that influence consultation behavior. Am J Gastroenterol. 2008;103:1229\u201339.","journal-title":"Am J Gastroenterol"},{"issue":"nov13 2","key":"1143_CR31","doi-asserted-by":"publisher","first-page":"a2313","DOI":"10.1136\/bmj.a2313","volume":"337","author":"A. C Ford","year":"2008","unstructured":"Ford AC, Talley NJ, Spiegel BMR, Foxx-Orenstein AE, Schiller L, Quigley EMM, Moayyedi P. Effect of fibre, antispasmodics, and peppermint oil in the treatment of irritable bowel syndrome: systematic review and meta-analysis. BMJ. 2008;337(nov13 2):a2313\u2013a2313.","journal-title":"BMJ"},{"key":"1143_CR32","doi-asserted-by":"crossref","unstructured":"Pogromov AP, Mnacakanjan MG, Tashhjan OV. Rasprostranennost\u2019 sindroma razdrazhennogo kishechnika. [Prevalence of irritable bowel syndrome]. Rossijskij zhurnal klinicheskoj mediciny. 2016;94(11):869\u201373. Russian.","DOI":"10.18821\/0023-2149-2016-94-11-869-874"},{"issue":"8","key":"1143_CR33","doi-asserted-by":"publisher","first-page":"755","DOI":"10.1016\/S0895-4356(00)00365-6","volume":"54","author":"L Rabeneck","year":"2001","unstructured":"Rabeneck L, Cook KF, Wristers K, Souchek J, Menke T, Wray NP. SODA (severity \u043ef dyspepsia assessment): a new effective outcome measure for dyspepsia-related health. J Clin Epidemiol. 2001;54(8):755\u201365.","journal-title":"J Clin Epidemiol"},{"issue":"11","key":"1143_CR34","doi-asserted-by":"publisher","first-page":"1804","DOI":"10.1038\/ajg.2014.237","volume":"109","author":"BM Spiegel","year":"2014","unstructured":"Spiegel BM, Hays RD, Bolus R, Melmed GY, Chang L, Whitman C, Khanna PP, Paz SH, Hays T, Reise S, Khanna D. Development of the NIH patient-reported outcomes measurement information system (PROMIS) gastrointestinal symptom scales. Am J Gastroenterol. 2014;109(11):1804\u201314.","journal-title":"Am J Gastroenterol"},{"key":"1143_CR35","unstructured":"Guideline on the evaluation of medicinal products for the treatment of irritable bowel syndrome EMA\/CHMP\/60337\/2013. https:\/\/www.ema.europa.eu\/documents\/scientific-guideline\/draft-guideline-evaluation-medicinal-products-treatment-irritable-bowel-syndrome-revision-1_en.pdf. Accessed 3 Jan 2019."}],"container-title":["BMC Gastroenterology"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s12876-019-1143-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s12876-019-1143-5\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s12876-019-1143-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,24]],"date-time":"2023-09-24T10:31:14Z","timestamp":1695551474000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcgastroenterol.biomedcentral.com\/articles\/10.1186\/s12876-019-1143-5"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,12,31]]},"references-count":35,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2020,12]]}},"alternative-id":["1143"],"URL":"https:\/\/doi.org\/10.1186\/s12876-019-1143-5","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.2.13285\/v1","asserted-by":"object"},{"id-type":"doi","id":"10.21203\/rs.2.13285\/v2","asserted-by":"object"}]},"ISSN":["1471-230X"],"issn-type":[{"value":"1471-230X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,12,31]]},"assertion":[{"value":"24 July 2019","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 December 2019","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"31 December 2019","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"According to GCP it is quite enough to obtain the approval at least the one for all sites. Since the huge numbers of medical organizations participated in the program it was decided to get unified approval accepted for non interventional study design by the Independent Interdisciplinary Ethics Committee on Ethical Review for Clinical Studies (hereinafter referred to as the \u201cCommittee\u201d). The Committee is the independent local research ethic committee, which was established in 2000 by Moscow State University of Medicine and Dentistry, Russian Academy of Medical Sciences, Society for Pharmacoeconomics and Outcomes Research, League to support clinical studies and Scientific Center for medical information \u201cUniversimed\u201d, have made, executed and signed corresponding Agreement. The COMFORT was approved by the Committee (Protocol \u2116 19 from 01.12.2017).","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Prof. Glazunov and Dr. Putilovskiy authored this publication as employees of LLC \u201cNPF\u201d MATERIA MEDICA HOLDING\u201d. Prof. Epstein is the founder of LLC \u201cNPF \u201cMATERIA MEDICA HOLDING\u201d. Kolofort is a preparation manufactured and marketed by LLC \u201cNPF\u201d MATERIA MEDICA HOLDING\u201d. The authors report no other conflicts of interest in this work.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"2"}}