Fish-Induced FPIES in Children in Greece: Study of the Natural History of the Disease

Fish-Induced FPIES in Children in Greece: Study of the Natural History of the Disease | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL This is a preprint and has not been peer reviewed. Data may be preliminary. 5 November 2025 V1 Latest version Share on Fish-Induced FPIES in Children in Greece: Study of the Natural History of the Disease Authors : Konstantinos Miliordos 0009-0003-2638-126X [email protected] , Maria Triga , Magdalini-Konstantina Tranou , Juan Trujillo 0000-0001-6369-6218 , and Sara Anvari 0000-0002-9942-6188 Authors Info & Affiliations https://doi.org/10.22541/au.176233204.41365212/v1 199 views 120 downloads Contents Abstract Conclusion Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Background: Food Protein-Induced Enterocolitis Syndrome (FPIES) is a non-IgE-mediated food allergy that typically presents in infancy with delayed gastrointestinal symptoms. While cow’s milk and soy are common triggers globally, fish appears to be a significant culprit in Mediterranean regions, including Greece. Objective: To describe the clinical characteristics, natural history, and follow-up outcomes of fish-induced FPIES in a pediatric Greek population. Methods: A retrospective review was conducted on 96 children, diagnosed with acute fish-induced FPIES at a tertiary pediatric allergy unit in Greece between October 2014 and June 2024. Data collected included demographics, atopic comorbidities, multiple food triggers and outcomes of oral food challenges (OFCs). Results: The median age at first reaction to fish was 11 months, and diagnosis was confirmed by 2 years. Most children (73%) experienced multiple FPIES episodes before diagnosis. Codfish was the most common offending fish and was used in all OFCs. During follow-up, 73% of patients developed tolerance at a median age of 5.5 years. The mean amount of fish protein tolerated during the OFC was 10 grams. Children with more pre-diagnostic episodes were significantly less likely to develop tolerance (p<0.001). Mild abdominal discomfort post-tolerance was noted in a subset of children resulting in consuming small portions of fish. No patients developed IgE sensitization to fish. Atopic comorbidities, particularly allergic rhinitis, were common. Conclusions: Fish-induced FPIES is a prevalent and underrecognized condition in Greek children as in other Mediterranean countries. Early diagnosis and avoidance of the trigger may improve outcomes. Tolerance in the offending food can be acquired in early childhood. Further prospective studies are needed to assess species-specific reactivity and long-term prognosis in Mediterranean populations. Fish-Induced FPIES in Children in Greece: Study of the Natural History of the Disease Running title: Fish-induced FPIES in Greek children Konstantinos Miliordos 1 , Maria Triga 1 , Magdalini-Konstantina Tranou 1 , Juan Trujillo 2 , Sara Anvari 3 1 Pediatric Allergy Unit, Department of Pediatrics, General University Hospital of Patras, Patras, Greece 2 Department of Pediatrics and Child Health, University College Cork, Cork, Ireland, United Kingdom 3 Division of Immunology, Allergy and Retrovirology, Texas Children’s Hospital; Department of Pediatrics, Baylor College of Medicine, Houston, TX Corresponding author: Konstantinos Miliordos, MD, MSc Pediatric Allergy Unit, General University Hospital of Patras 26504 Patras, Greece Email: [email protected] Word count: 2958 Figures: 1 Tables: 1 Funding: No external funding was received. Conflicts of interest: The authors declare no conflicts of interest. Author contributions: Konstantinos Miliordos and Maria Triga designed the study. Konstantinos Miliordos and Magdalini-Konstantina Tranou collected data and organized the Oral Food Challenges. Juan Trujillo and Sara Anvari supervised the analysis and reviewed the manuscript. All authors reviewed and approved the final version. Key Messages • Fish is the leading FPIES trigger among Greek children. • Most children develop tolerance by age 6 years. • Multiple reactions before diagnosis may predict a more prolonged course of the disease. • Many children can tolerate more than 3gr of protein during the Oral Food Challenge. • Even after a negative challenge children may experience symptoms of abdominal discomfort. • Atopic comorbidity coexists in children with FPIES, with allergic rhinitis being the most prevalent Abstract Background: Food Protein-Induced Enterocolitis Syndrome (FPIES) is a non-IgE-mediated food allergy that typically presents in infancy with delayed gastrointestinal symptoms. While cow’s milk and soy are common triggers globally, fish appears to be a significant culprit in Mediterranean regions, including Greece. Objective: To describe the clinical characteristics, natural history, and follow-up outcomes of fish-induced FPIES in a pediatric Greek population. Methods: A retrospective review was conducted on 96 children, diagnosed with acute fish-induced FPIES at a tertiary pediatric allergy unit in Greece between October 2014 and June 2024. Data collected included demographics, atopic comorbidities, multiple food triggers and outcomes of oral food challenges (OFCs). Results: The median age at first reaction to fish was 11 months, and diagnosis was confirmed by 2 years. Most children (73%) experienced multiple FPIES episodes before diagnosis. Codfish was the most common offending fish and was used in all OFCs. During follow-up, 73% of patients developed tolerance at a median age of 5.5 years. The mean amount of fish protein tolerated during the OFC was 10 grams. Children with more pre-diagnostic episodes were significantly less likely to develop tolerance (p<0.001). Mild abdominal discomfort post-tolerance was noted in a subset of children resulting in consuming small portions of fish. No patients developed IgE sensitization to fish. Atopic comorbidities, particularly allergic rhinitis, were common. Conclusions: Fish-induced FPIES is a prevalent and underrecognized condition in Greek children as in other Mediterranean countries. Early diagnosis and avoidance of the trigger may improve outcomes. Tolerance in the offending food can be acquired in early childhood. Further prospective studies are needed to assess species-specific reactivity and long-term prognosis in Mediterranean populations. Word count: 248 Keywords: FPIES, fish allergy, oral food challenge, tolerance, children Introduction Food Protein-Induced Enterocolitis Syndrome (FPIES) is a non-IgE-mediated food allergy that primarily affects infants and young children. It is characterized by delayed-onset gastrointestinal symptoms such as profuse vomiting, pallor, lethargy, less frequently diarrhea and in more severe cases, hypovolemic shock. 1,2 FPIES represents a distinct clinical entity that can frequently be under-recognized or misdiagnosed. Unlike classic IgE-mediated food allergies, FPIES involves a T-cell-driven immune response with the clinical symptomatology typically manifesting 1 to 4 hours after ingestion of the triggering food. 1,3,4 FPIES triggers can vary by age, dietary preferences and geographical region. While cow’s milk and soy are considered the most common triggers in many countries 5 , fish has emerged as a significant trigger primarily in Mediterranean countries like Spain and Italy 6–9 . In Greece, where fish is a staple of the traditional diet and commonly introduced early during infant weaning, there appears to be an increasing number of patients with fish-related FPIES compared to other regions worldwide. 7,10 Although large-scale epidemiological studies on FPIES in Greece are lacking, existing hospital-based reports and clinical case series suggest that fish is a leading trigger among solid foods and may account for up to 35% of food-induced FPIES cases, a significantly higher rate than reported in Northern European or American cohorts, where fish is a less frequent trigger. 10,11 Among Greek children with solid food FPIES, common culprits include cod and sole, species regularly consumed by families across the country. 10,11 Notably, most reactions occur during infancy, coinciding with the period of dietary diversification. 3 Despite these observations, fish-induced FPIES remains underdiagnosed in the Greek pediatric population. The non-specific nature of symptoms and lack of widely accepted diagnostic biomarkers often result in misdiagnosis and delayed identification, leading to repeated episodes and parental distress. 4,7 This study aims to present clinical data on pediatric FPIES cases triggered by fish, the natural history of the disease and follow up outcomes. Study Design This is a retrospective study including children with a diagnosis of acute FPIES in fish assessed in the Pediatric Allergy Unit of General University Hospital of Patras in Patras, Greece, between October 2014 and June 2024. The study was approved by the local Institutional Review Board, and all the parents gave the corresponding inform consent. Patients between the ages of 0 to 18 years were included. A detailed clinical history was performed, and diagnosis was based on the criteria of Sicherer et al. 12 modified by Nowak-Węgrzyn et al. 1 The age of initial reaction and diagnosis, sex, offending fish, number of episodes before diagnosis and time intervals from diagnosis to tolerance were registered. In addition, gestational age, delivery method and duration of breastfeeding and coexistence of other atopic disorders, FPIES to other culprit foods, family history of atopy were also recorded. At the initial evaluation, sensitization to the fish and other common allergenic food was assessed by skin prick tests (SPTs) using commercial extracts (LETI Pharma) and/or specific (s)IgE determination (ImmunoCAP, Thermo Fisher Scientific) depending on availability. An elimination diet was suggested to the families. Clinical revaluation was performed annually while OFCs for tolerance evaluation were not performed at specifically predefined time points, at least 12 months after last reaction, but rather according to clinical judgment and parental preferences. All the OFCs were performed in the hospital setting. Prior to OFCs, IgE sensitization was assessed by skin prick tests (SPTs) and/or specific (s)IgE determination. SPTs were considered positive when the maximum wheal size for the culprit food was ≥3 mm compared to the negative control (NaCl 0.9%) and sIgE was ≥0.35 kU/L. 10 Study Parameters On review of patient records, there were children that had performed an OFC according to the consensus guidelines of Nowak-Węgrzyn et al. 1 Those patients that had not performed OFC recently or had not achieved tolerance were contacted to undergo an OFC in the hospital setting with the implicated food in a regularly processed form (boiled fish). They were performed with codfish and in the same way. Before the OFC, vital signs were taken, and the food offered was weighed. During the OFC, children received a single dose of approximately 50% of the appropriate serving size per age. 13 The appropriate serving size was determined according to the official recommendations of the Hellenic Nutritionists Society. 14 The OFC was considered positive in cases where repetitive vomiting occurred within 1–4 h (or more) following consumption of the offending food, without concurrent skin, respiratory, and/or systemic manifestations or any other apparent pathology. An intravenous line was placed in all children prior to the OFC, and resuscitation equipment was readily available with the addition of ondansetron. In case of severe/repetitive emesis during the OFC, intravenous fluid resuscitation was also provided. All patients were observed for at least 4 hours after each OFC. 3,6 Following the OFC, families were contacted monthly for the first 6 months to confirm tolerance and they were encouraged to regularly ingest an age-appropriate serving size. They were also advised to decrease the dose to half of the portion if they experienced any symptoms after fish consumption. Statistical Analysis For the statistical analysis, the Mann-Whitney U was used to compare nonparametric independent samples; Pearson’s χ2 test of independence was used to identify univariate dependencies between categorical variables. Means and 95% confidence intervals (CI) or medians and interquartile ranges were used for quantitative variables, as appropriate. SPSS v20.0 (IBM, Chicago, IL, USA) statistical software was used for data analysis. A P value of less than .05 was considered significant. N (%) of patients (N = 96) Sex Male 50 (52.1) Female 46 (47.9) Age at First reaction, months (median, IQR) 11.7(9-12) Age of Diagnosis (years) (median, IQR) 2.29(1-2.8) Number of episodes before diagnosis (mean, range) 2 (1-5) No. of patients with multiple episodes 70 (73) 2 41 (58.5) 3 18 (25.7) 4 10 (14.3) 5 1 (1.5) Gestational age Full term 90 (93.8) Preterm 6 (6.3) Delivery method Caesarean section 56 (58.3) Vaginal delivery 40 (41.7) Feeding method Breast-fed 65 (67.7) Formula fed 31 (32.3) Duration of breastfeeding (months) M:6 Other triggers Yes 18 (18.8) No 78 (81.3) Number of triggers 1 78 (81.3) 2 17 (17.7) >3 1 (1) If yes what triggers Chicken 6 (33.3) Egg 7 (38.9) Milk 3 (16.7) Shellfish 1 (5.6) IgE food allergy Yes 12 (12.5) No 84 (87.5) If yes, what trigger; Egg 6 (50) Milk 5 (41.7) Tree nuts 1 (8.3) Personal history of atopy Yes 29 (30.2) No 67 (69.8) If yes what; Allergic Rhinitis 18 (64.2) Atopic dermatitis 8 (28.5) Asthma 2 (7.3) Family history of atopy Yes 41 (42.7) No 55 (57.3) Table 1. Demographic and clinical characteristics of patients with fish-induced FPIES (N = 96). Data are presented as number (percentage), median (interquartile range, IQR), or mean (range). RESULTS Patients’ characteristics are summarized in Table 1. Ninety-six children were enrolled in this study: 46 female (47.9%) and 50 male (52.1%) during the period of October 2014 and June 2024. The mean age at first episode was 11 months (95% CI: 7.7–12.5, IQR 9-12). The mean age of diagnosis was 2 years (IQR: 1-2.8). The mean number of episodes the patients experienced before diagnosis was 2 (range 1-5). Seventy patients (73%) experienced multiple episodes with 41 (58.5%) experiencing 2 episodes, 18 (25.7 %) having 3 episodes, 10 (14.3 %) having 4 episodes and 1 (1.5 %) experiencing 5 episodes pre FPIES diagnosis. Most patients were born full term (93.8%). 56 patients (58.3%) were delivered via caesarean section and 40(41.7%) via vaginal delivery, while 65 (67.7%) were breastfed with a mean duration of breastfeeding 6 months (IQR 3-9). and 31 (32.3%) were formula fed. 18 (18.8 %) patients reacted to other triggers, 17 of them had 2 triggers while 1 reacted to 4 triggers. The most common trigger among them was egg (38.9%), followed by chicken (33.3%), milk (16.7%) and shellfish (5.6%). 12 patients (12.5%) had concomitant IgE mediated food allergy with egg (50%) being the most common followed by milk and tree nuts. 29 patients (30.2%) had a personal history of atopy. Among them, 18 patients (64.2%) had comorbid allergic rhinitis. Atopic dermatitis was the next most common atopic comorbidity, followed by asthma. Almost half of patients with fish-FPIES had a family history of atopy. Tolerance development Tolerance to fish was achieved in 70 (72,9%) children (36 boys). The median age of fish tolerance was 5.5 (IQR 3.4-7) years. During the follow up we recorded that 51 patients tolerated fish by performing OFCs. The OFCs were performed in the hospital setting by giving cod as a single dose with a maximum fish protein of 3 grams. The median age of patients tolerating fish during the follow up was 4.5 years (SD 1.8, 95%CI 4-5, IQR 3-5.5). Twenty-six (27,1%) remained on an exclusion diet and were advised to undergo an OFC in the hospital setting. Eighteen patients did not consent to the OFC due to the unpleasant experience of vomiting and six decided to perform an OFC at home despite advice against this, with a positive outcome (failure of tolerance) in all of them. The remaining 21 children accepted and underwent the OFC in the hospital setting. Tolerance is shown in Figure 1. Figure 1 . Flow chart of patient inclusion and distribution according to tolerance and outcome of the OFC. During the study period, 21 OFCs were performed with cod in the hospital setting on patients that remained on an exclusion diet. On the day of the OFC, the patients underwent clinical examination, SPTs were performed to codfish with a negative outcome in all of them. Codfish was weighed and patients received half of the age-appropriate serving size in a single dose, and they remained in observation for at least 4 hours. Nineteen (90%) subjects had a negative outcome, while 2 were positive. Repetitive vomiting occurred in both; 2 hours post fish consumption. Intravenous fluids were administered, with no need for ondansetron or hospitalization. The patients that performed the OFC had a mean age of 8.4 (95% CI 7.7-9.1) years and the mean quantity of fish they consumed was 56 grams (IQR: 40-70) which corresponded to 10 grams of fish protein. Following tolerance on OFC, the 70 patients that tolerated fish were followed up for more than 6 months. It was reported that although they all could eat fish with no symptomatology, 62 (88.6%) could eat an age-appropriate full portion and 8 (11.4%) ate half a portion. In addition, it was reported that 10 children (14.3%) reported a symptom of diffuse abdominal discomfort 2 to 4 hours after fish consumption with no other symptoms. It was also found that children that tolerated fish but consumed half of the age-appropriate portion reported more frequent symptoms of abdominal discomfort than children that consumed an age-appropriate full portion of fish. (p<0.001) In children that did not tolerate fish during the OFC, they had reported more FPIES episodes prior to their diagnosis than children who tolerated fish at a statistically significant rate (p<0.001). The mean time interval between diagnosis and induction of tolerance was 3.7 years (IQR 2-5). No patient developed IgE sensitization to fish. No statistically significant association was found between the induction of tolerance and gestational age, delivery method and feeding method. Discussion Although FPIES to fish has been previously reported, there have been relatively few large epidemiological studies despite its high prevalence in Mediterranean countries. 8,9,15 The age of onset seems to depend on the geographical differences and the dietary preferences of each country. 6 This study provides a comprehensive overview of fish-induced FPIES in Greek children, highlighting the high prevalence of fish as a culprit food in this Mediterranean population. Our findings confirm the unique epidemiological pattern of FPIES in Greece, where frequent consumption during weaning and cultural dietary practices may contribute to a higher incidence compared to reports from other geographic regions. 8,16 The median age at first reaction (11 months) and diagnosis (2 years) coincides with the period of dietary diversification, supporting the notion that early introduction of fish may influence sensitization patterns as fish is one of the nutrients that are early introduced during infancy in Greece. A few children had reactions to multiple foods, particularly egg and chicken, which are also early weaning foods. This suggests that children prone to FPIES may exhibit a broader sensitivity profile during infancy. 16,17 More than 70% of our study experienced multiple episodes before diagnosis, underlining the need for heightened clinical suspicion among pediatricians and primary care providers. 9,18 Cod, used as the challenge food in all OFCs, represents a commonly consumed fish species in Greece and was tolerated by 73% of children during follow-up. The median age of tolerance was 5.5 years, which is consistent with current studies regarding tolerance in this trigger. 6,15 It seems that tolerance in fish occurs later than tolerance typically reported for milk or soy-induced FPIES. 5 This suggests that fish-induced FPIES may follow a more protracted course, consistent with previous reports indicating that solid food-induced FPIES tend to persist longer than milk or soy FPIES. 7 Notably, children with more reactions prior to diagnosis were likely to remain intolerant due to their refusal to undergo an OFC. We should hypothesize that early elimination and avoidance may lessen family distress from the dramatic experience of repetitive vomiting and lead towards willingness to perform OFC and assess for tolerance. 3,18 While there are no standardized protocols for the OFCs, guidelines suggest that the triggering food can be given in a single dose with a maximum of 3 g of protein, and observation should follow for 4-6 hours. The OFCs performed in our study had a favorable outcome in most patients. Our mean dosing exceeded 3 g, and this outcome suggests that 3 g of protein may be quite small for children. 13 Importantly, none of the patients developed IgE sensitization to fish, confirming that FPIES remains a non-IgE-mediated disorder. 10 Furthermore, no associations were found between tolerance development and perinatal factors such as delivery method, feeding practices, or gestational age—factors that have been linked with food allergy development. 5,15,16 Interestingly, children who achieved tolerance, but only consumed half of the age-appropriate serving size were more likely to report mild postprandial abdominal discomfort. To our knowledge this is the first time that this sole symptom has been described without the implication of positive OFC. Although these symptoms were not consistent with classic FPIES reactions, they may reflect a lingering hypersensitivity and gastrointestinal inflammation or anxiety around the reintroduction of previously reactive foods. Further studies should explore whether these symptoms represent immune activation or are psychosomatic in nature. Similar to the literature published, our study shows that atopic comorbidity coexists in FPIES. However, allergic rhinitis with sensitization to dust mite was the most prevalent, while atopic dermatitis is described as the most common. This can stem from the fact that most patients will have likely developed allergic rhinitis during school age. 2 Our study has several strengths, including a relatively large cohort for a single-center study and a standardized diagnostic and follow-up protocol. The relatively large sample size and systematic follow-up strengthen the validity of our conclusions. However, it also has limitations. As a retrospective study, it is subject to recall bias and potential underreporting of mild or atypical reactions. Additionally, one area that merits further study is species-specific reactivity. In our study cod was the primary trigger and the only fish that was used for OFC, and we cannot fully assess whether tolerance extends to other species commonly consumed in Greece, such as tuna or sole. Conclusion Fish-induced Food Protein-Induced Enterocolitis Syndrome (FPIES) is a notable clinical concern in Greek pediatric populations, reflecting regional dietary patterns and highlighting the importance of cultural context in food allergy epidemiology. Our findings emphasize the need for increased awareness among healthcare professionals, as early diagnosis can prevent multiple adverse reactions and improve patient outcomes. Although most children eventually outgrow fish-induced FPIES, the timeline to tolerance can be prolonged, underlining the value of continuing monitoring and individualized reintroduction strategies. Future multicenter, prospective studies are warranted to better define natural history, potential sensitization differences among fish species, and long-term outcomes in Mediterranean settings. References 1. Nowak-Węgrzyn A, Chehade M, Groetch ME, Spergel JM, Wood RA, Allen K, et al. International consensus guidelines for the diagnosis and management of food protein-induced enterocolitis syndrome: Executive summary-Workgroup Report of the Adverse Reactions to Foods Committee, American Academy of Allergy, Asthma & Immunology. J Allergy Clin Immunol. 2017 Apr;139(4):1111-1126.e4. 2. Ruffner MA, Wang KY, Dudley JW, Cianferoni A, Grundmeier RW, Spergel JM, et al. Elevated Atopic Comorbidity in Patients with Food Protein-Induced Enterocolitis. J Allergy Clin Immunol Pract. 2020 Mar;8(3):1039–46. 3. Anvari S, Ruffner MA, Nowak-Wegrzyn A. Current and future perspectives on the consensus guideline for food protein-induced enterocolitis syndrome (FPIES). Allergol Int. 2024 Apr;73(2):188–95. 4. Pérez Ajami RI, Carrión Sari SK, Aliaga Mazas Y, Calvo JB, Guallar Abadía MI. [Experience in food protein-induced enterocolitis syndrome in a paediatric allergy clinic]. An Pediatr (Engl Ed). 2020 Jun;92(6):345–50. 5. Katz Y, Goldberg MR, Rajuan N, Cohen A, Leshno M. The prevalence and natural course of food protein-induced enterocolitis syndrome to cow’s milk: a large-scale, prospective population-based study. J Allergy Clin Immunol. 2011 Mar;127(3):647-53.e1-3. 6. Nowak-Węgrzyn A, Jarocka-Cyrta E, Moschione Castro A. Food Protein-Induced Enterocolitis Syndrome. J Investig Allergol Clin Immunol. 2017;27(1):1–18. 7. Prattico C, Mulé P, Ben-Shoshan M. A Systematic Review of Food Protein-Induced Enterocolitis Syndrome. 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Allergol Immunopathol (Madr). 2005;33(6):312–6. 18. Haddad C, Banerjee A, Eubanks J, Rana R, Rider NL, Pompeii L, et al. A Second Slice of FPIES: A Single-Center Reappraisal of Pediatric FPIES. J Allergy Clin Immunol Pract. 2024 Aug;12(8):2118–26. Information & Authors Information Version history V1 Version 1 05 November 2025 Copyright This work is licensed under a Non Exclusive No Reuse License. Authors Affiliations Konstantinos Miliordos 0009-0003-2638-126X [email protected] General University Hospital of Patras View all articles by this author Maria Triga General University Hospital of Patras View all articles by this author Magdalini-Konstantina Tranou General University Hospital of Patras View all articles by this author Juan Trujillo 0000-0001-6369-6218 University College Cork Department of Paediatrics and Child Health View all articles by this author Sara Anvari 0000-0002-9942-6188 Texas Children's Hospital Department of Allergy and Immunology View all articles by this author Metrics & Citations Metrics Article Usage 199 views 120 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Konstantinos Miliordos, Maria Triga, Magdalini-Konstantina Tranou, et al. Fish-Induced FPIES in Children in Greece: Study of the Natural History of the Disease. Authorea . 05 November 2025. 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