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1. Assessing the Long-Term Role of Vaccination against HPV after Loop Electrosurgical Excision Procedure (LEEP): A Propensity-Score Matched Comparison

Author

Giorgio Bogani, Francesco Raspagliesi, Francesco Sopracordevole, Andrea Ciavattini, Alessandro Ghelardi, Tommaso Simoncini, Marco Petrillo, Francesco Plotti, Salvatore Lopez, Jvan Casarin, Maurizio Serati, Ciro Pinelli, Gaetano Valenti, Alice Bergamini, Barbara Giannella, Andrea Dell’Acqua, Ermelinda Monti, Paolo Vercellini, Giovanni D’ippolito, Lorenzo Aguzzoli, Vincenzo D Mandato, Paola Carunchio, Gabriele Carlifante, Luca Giannella, Cono Scaffa, Francesca Falcone, Stefano Ferla, Chiara Borghi, Antonino Ditto, Mario Malzoni, Andrea Giannini, Maria Giovanna Salerno, Viola Liberale, Biagio Contino, Cristina Donfrancesco, Michele Desiato, Anna Myriam Perrone, Giulia Dondi, Pierandrea De Iaco, Umberto Leone Roberti Maggiore, Mauro Signorelli, Valentina Chiappa, Simone Ferrero, Giuseppe Sarpietro, Maria G Matarazzo, Antonio Cianci, Sara Bocio, Simona Ruisi, Rocco Guerrisi, Claudia Brusadelli, Lavinia Mosca, Raffaele Tinelli, Rosa De Vincenzo, Gian Franco Zannoni, Gabriella Ferrandina, Salvatore Dessole, Roberto Angioli, Stefano Greggi, Arsenio Spinillo, Fabio Ghezzi, Nicola Colacurci, Margherita Fischetti, Annunziata Carlea, Fulvio Zullo, Ludovico Muzii, Giovanni Scambia, Pierluigi Benedetti Panici, and Violante Di Donato

Subjects
HPV, vaccination, conization, LEEP, Medicine
Abstract

Background: Primary prevention through vaccination is a prophylactic approach aiming to reduce the risk of developing human papillomavirus (HPV)-related lesions. No mature and long-term data supported the adoption of vaccination in women undergoing conization. Methods: This is a retrospective multi-institutional study. Charts of consecutive patients undergoing conization between 2010 and 2014 were collected. All patients included had at least 5 years of follow-up. We compared outcomes of patients undergoing conization plus vaccination and conization alone. A propensity-score matching algorithm was applied in order to reduce allocation biases. The risk of developing recurrence was estimated using Kaplan-Meir and Cox hazard models. Results: Overall, charts of 1914 women were analyzed. The study group included 116 (6.1%) and 1798 (93.9%) women undergoing conization plus vaccination and conization alone, respectively. Five-year recurrence rate was 1.7% (n = 2) and 5.7% (n = 102) after conization plus vaccination and conization alone, respectively (p = 0.068). After the application of a propensity-score matching, we selected 100 patients undergoing conization plus vaccination and 200 patients undergoing conization alone. The crude number of recurrences was 2 (2%) and 11 (5.5%) for patients undergoing conization plus vaccination and conization alone, respectively (p = 0.231). Vaccination had no impact on persistent lesions (no negative examination between conization and new cervical dysplasia; p = 0.603), but reduced the risk of recurrent disease (patients who had at least one negative examination between conization and the diagnosis of recurrent cervical dysplasia; p = 0.031). Conclusions: Patients having vaccination experience a slightly lower risk of recurrence than women who had not, although not statistically significantly different. Further evidence is needed to assess the cost effectiveness of adopting vaccination in this setting.

Published
2020
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2. High-risk HPV-positive and -negative high-grade cervical dysplasia: Analysis of 5-year outcomes

Author

Giovanni Scambia, Mario Malzoni, Lavinia Mosca, Lorenzo Aguzzoli, Nicola Colacurci, Gabriele Carlinfante, Marco Petrillo, Stefano Greggi, Paolo Vercellini, Antonio Cianci, Francesco Raspagliesi, Andrea Giannini, Andrea Ciavattini, Viola Liberale, Sara Bosio, Luca Giannella, Maurizio Serati, Rocco Guerrisi, Simone Ferrero, Michele Desiato, Pierandrea De Iaco, Anna Myriam Perrone, Giorgio Bogani, Fabio Ghezzi, Biagio Contino, Francesca Falcone, Arsenio Spinillo, Francesco Sopracordevole, Claudia Brusadelli, Antonio Simone Laganà, Simona Ruisi, Maria Grazia Matarazzo, Pierluigi Benedetti Panici, Paola Carunchio, Giuseppe Sarpietro, Alessandro Ghelardi, Barbara Gardella, Francesco Plotti, Alice Bergamini, Margherita Fischetti, Antonino Ditto, Gian Franco Zannoni, Gabriella Ferrandina, Vincenzo Dario Mandato, Valentina Chiappa, Violante Di Donato, Raffaele Tinelli, Ermelinda Monti, Roberto Angioli, Salvatore Dessole, Annunziata Carlea, Ciro Pinelli, Fulvio Zullo, Salvatore Lopez, Sara Lovati, Tommaso Simoncini, Maria Giovanna Salerno, Mauro Signorelli, Rosa De Vincenzo, Cono Scaffa, Jvan Casarin, Chiara Borghi, Cristina Donfrancesco, Ludovico Muzii, Giovanni D'ippolito, Gaetano Valenti, Andrea Dell'Acqua, Giulia Dondi, Bogani, G., Sopracordevole, F., Di Donato, V., Ciavattini, A., Ghelardi, A., Lopez, S., Simoncini, T., Plotti, F., Casarin, J., Serati, M., Pinelli, C., Valenti, G., Bergamini, A., Gardella, B., Dell'Acqua, A., Monti, E., Vercellini, P., Fischetti, M., D'Ippolito, G., Aguzzoli, L., Mandato, V. D., Carunchio, P., Carlinfante, G., Giannella, L., Scaffa, C., Falcone, F., Borghi, C., Ditto, A., Malzoni, M., Giannini, A., Salerno, M. G., Liberale, V., Contino, B., Donfrancesco, C., Desiato, M., Perrone, A. M., Dondi, G., De Iaco, P., Chiappa, V., Ferrero, S., Sarpietro, G., Matarazzo, M. G., Cianci, A., Bosio, S., Ruisi, S., Guerrisi, R., Brusadelli, C., Mosca, L., Lagana', A. S., Tinelli, R., Signorelli, M., De Vincenzo, R., Zannoni, G. F., Ferrandina, G., Lovati, S., Petrillo, M., Dessole, S., Carlea, A., Zullo, F., Angioli, R., Greggi, S., Spinillo, A., Ghezzi, F., Colacurci, N., Muzii, L., Benedetti Panici, P., Scambia, G., Raspagliesi, F., Bogani G., Sopracordevole F., Di Donato V., Ciavattini A., Ghelardi A., Lopez S., Simoncini T., Plotti F., Casarin J., Serati M., Pinelli C., Valenti G., Bergamini A., Gardella B., Dell'acqua A., Monti E., Vercellini P., Fischetti M., D'ippolito G., Aguzzoli L., Mandato V.D., Carunchio P., Carlinfante G., Giannella L., Scaffa C., Falcone F., Borghi C., Ditto A., Malzoni M., Giannini A., Salerno M.G., Liberale V., Contino B., Donfrancesco C., Desiato M., Perrone A.M., Dondi G., De Iaco P., Chiappa V., Ferrero S., Sarpietro G., Matarazzo M.G., Cianci A., Bosio S., Ruisi S., Guerrisi R., Brusadelli C., Mosca L., Lagana' A.S., Tinelli R., Signorelli M., De Vincenzo R., Zannoni G.F., Ferrandina G., Lovati S., Petrillo M., Dessole S., Carlea A., Zullo F., Angioli R., Greggi S., Spinillo A., Ghezzi F., Colacurci N., Muzii L., Benedetti Panici P., Scambia G., and Raspagliesi F.

Subjects
0301 basic medicine, Adult, medicine.medical_specialty, HPV, Uterine Cervical Neoplasm, Prognosi, CIN, conization, negative, positive, Conization, Uterine Cervical Neoplasms, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Risk Factors, Retrospective Studie, medicine, Humans, Cervical Intraepithelial Neoplasia, Prospective cohort study, Propensity Score, Papillomavirus Infection, Retrospective Studies, Obstetrics, Proportional hazards model, business.industry, Risk Factor, Papillomavirus Infections, Obstetrics and Gynecology, Retrospective cohort study, Middle Aged, Prognosis, medicine.disease, Negative, Uterine Cervical Dysplasia, female genital diseases and pregnancy complications, 030104 developmental biology, Settore MED/40 - GINECOLOGIA E OSTETRICIA, Oncology, Dysplasia, 030220 oncology & carcinogenesis, Cohort, Propensity score matching, Population study, Female, business, Positive, Cohort study, Human
Abstract

Objective: To evaluate the outcomes of high-risk (HR) HPV-positive and -negative women affected by high-grade cervical dysplasia. Methods: This is a retrospective multi-institutional study. Medical records of consecutive patients with high-grade cervical dysplasia undergoing conization between 2010 and 2014 were retrieved. All patients included had at least 5 years of follow-up. A propensity-score matching was adopted in order to reduce the presence of confounding factors between groups. Kaplan-Meir and Cox hazard models were used to estimate 5-year outcomes. Results: Overall, data of 2966 women, affected by high-grade cervical dysplasia were reviewed. The study population included 1478 (85%) and 260 (15%) women affected by HR-HPV-positive and HR-HPV-negative high-grade cervical dysplasia. The prevalence of CIN2 and CIN3 among the HR-HPV-positive and -negative cohort was similar (p = 0.315). Patients with HR-HPV-positive high-grade cervical dysplasia were at higher risk of 5-year recurrence (after primary conization) that HR-HPV-negative patients (p < 0.001, log-rank test). Via multivariate analysis, HR-HPV-negative women were at low risk of recurrence (HR: 1.69 (95%CI: 1.05, 4.80); p = 0.018, Cox Hazard model). A propensity-score matched comparison was carried out in order to reduce biases that are related to the retrospective study design. In comparison to HR-HPV-negative patients, thosewith HR-HPV-positive CIN3 was associate with a 8-fold increase in the risk of recurrence (p < 0.001, log-rank test). Conclusions: HR-HPV-negative high-grade cervical dysplasia is not uncommon, accounting for 15% of our study population. Those patients experience more favorable outcomes than patients with documented HR-HPV infection(s). Further prospective studies are needed to corroborate our data.

Published
2021

3. Assessing the Long-Term Role of Vaccination against HPV after Loop Electrosurgical Excision Procedure (LEEP): A Propensity-Score Matched Comparison

Author

Mario Malzoni, Gaetano Valenti, Lavinia Mosca, Stefano Ferla, Nicola Colacurci, Paolo Vercellini, Antonio Cianci, Rocco Guerrisi, Claudia Brusadelli, Biagio Contino, Giovanni Scambia, Andrea Ciavattini, Umberto Leone Roberti Maggiore, Pierluigi Benedetti Panici, Gabriella Ferrandina, Stefano Greggi, Gabriele Carlifante, Giorgio Bogani, Barbara Gardella, Margherita Fischetti, Simone Ferrero, Maurizio Serati, Ciro Pinelli, Salvatore Lopez, Fulvio Zullo, Anna Myriam Perrone, Mauro Signorelli, Rosa De Vincenzo, Andrea Giannini, Raffaele Tinelli, Vincenzo Dario Mandato, Jvan Casarin, Arsenio Spinillo, Francesco Sopracordevole, Francesco Plotti, Violante Di Donato, Viola Liberale, Maria Grazia Matarazzo, Antonino Ditto, Annunziata Carlea, Ermelinda Monti, Lorenzo Aguzzoli, Maria Giovanna Salerno, Cono Scaffa, Francesca Falcone, Michele Desiato, Valentina Chiappa, Pierandrea De Iaco, Roberto Angioli, Alice Bergamini, Salvatore Dessole, Marco Petrillo, Simona Ruisi, Francesco Raspagliesi, Giulia Dondi, Fabio Ghezzi, Giovanni D'ippolito, Sara Bocio, Andrea Dell'Acqua, Giuseppe Sarpietro, Chiara Borghi, Alessandro Ghelardi, Paola Carunchio, Luca Gianella, Tommaso Simoncini, Cristina Donfrancesco, Ludovico Muzii, Gian Franco Zannoni, Bogani, G., Raspagliesi, F., Sopracordevole, F., Ciavattini, A., Ghelardi, A., Simoncini, T., Petrillo, M., Plotti, F., Lopez, S., Casarin, J., Serati, M., Pinelli, C., Valenti, G., Bergamini, A., Gardella, B., Dell'Acqua, A., Monti, E., Vercellini, P., D'Ippolito, G., Aguzzoli, L., Mandato, V. D., Carunchio, P., Carlifante, G., Giannella, L., Scaffa, C., Falcone, F., Ferla, S., Borghi, C., Ditto, A., Malzoni, M., Giannini, A., Salerno, M. G., Liberale, V., Contino, B., Donfrancesco, C., Desiato, M., Perrone, A. M., Dondi, G., De Iaco, P., Maggiore, U. L. R., Signorelli, M., Chiappa, V., Ferrero, S., Sarpietro, G., Matarazzo, M. G., Cianci, A., Bocio, S., Ruisi, S., Guerrisi, R., Brusadelli, C., Mosca, L., Tinelli, R., De Vincenzo, R., Zannoni, G. F., Ferrandina, G., Dessole, S., Angioli, R., Greggi, S., Spinillo, A., Ghezzi, F., Colacurci, N., Fischetti, M., Carlea, A., Zullo, F., Muzii, L., Scambia, G., Panici, P. B., Di Donato, V., Bogani G., Raspagliesi F., Sopracordevole F., Ciavattini A., Ghelardi A., Simoncini T., Petrillo M., Plotti F., Lopez S., Casarin J., Serati M., Pinelli C., Valenti G., Bergamini A., Gardella B., Dell'acqua A., Monti E., Vercellini P., D'ippolito G., Aguzzoli L., Mandato V.D., Carunchio P., Carlifante G., Giannella L., Scaffa C., Falcone F., Ferla S., Borghi C., Ditto A., Malzoni M., Giannini A., Salerno M.G., Liberale V., Contino B., Donfrancesco C., Desiato M., Perrone A.M., Dondi G., De Iaco P., Maggiore U.L.R., Signorelli M., Chiappa V., Ferrero S., Sarpietro G., Matarazzo M.G., Cianci A., Bocio S., Ruisi S., Guerrisi R., Brusadelli C., Mosca L., Tinelli R., De Vincenzo R., Zannoni G.F., Ferrandina G., Dessole S., Angioli R., Greggi S., Spinillo A., Ghezzi F., Colacurci N., Fischetti M., Carlea A., Zullo F., Muzii L., Scambia G., Panici P.B., and Di Donato V.

Subjects
medicine.medical_specialty, HPV, Cost effectiveness, Immunology, lcsh:Medicine, Lower risk, Article, 03 medical and health sciences, conization, 0302 clinical medicine, Primary prevention, Drug Discovery, medicine, Recurrent disease, LEEP, Pharmacology (medical), 030212 general & internal medicine, leep, vaccination, Pharmacology, Obstetrics, business.industry, lcsh:R, medicine.disease, Vaccination, Settore MED/40 - GINECOLOGIA E OSTETRICIA, Infectious Diseases, Loop electrosurgical excision procedure, Dysplasia, 030220 oncology & carcinogenesis, Propensity score matching, business
Abstract

Background: Primary prevention through vaccination is a prophylactic approach aiming to reduce the risk of developing human papillomavirus (HPV)-related lesions. No mature and long-term data supported the adoption of vaccination in women undergoing conization. Methods: This is a retrospective multi-institutional study. Charts of consecutive patients undergoing conization between 2010 and 2014 were collected. All patients included had at least 5 years of follow-up. We compared outcomes of patients undergoing conization plus vaccination and conization alone. A propensity-score matching algorithm was applied in order to reduce allocation biases. The risk of developing recurrence was estimated using Kaplan-Meir and Cox hazard models. Results: Overall, charts of 1914 women were analyzed. The study group included 116 (6.1%) and 1798 (93.9%) women undergoing conization plus vaccination and conization alone, respectively. Five-year recurrence rate was 1.7% (n = 2) and 5.7% (n = 102) after conization plus vaccination and conization alone, respectively (p = 0.068). After the application of a propensity-score matching, we selected 100 patients undergoing conization plus vaccination and 200 patients undergoing conization alone. The crude number of recurrences was 2 (2%) and 11 (5.5%) for patients undergoing conization plus vaccination and conization alone, respectively (p = 0.231). Vaccination had no impact on persistent lesions (no negative examination between conization and new cervical dysplasia, p = 0.603), but reduced the risk of recurrent disease (patients who had at least one negative examination between conization and the diagnosis of recurrent cervical dysplasia, p = 0.031). Conclusions: Patients having vaccination experience a slightly lower risk of recurrence than women who had not, although not statistically significantly different. Further evidence is needed to assess the cost effectiveness of adopting vaccination in this setting.

Published
2020
Full Text
View/download PDF

4. Recurrence rate after loop electrosurgical excision procedure (LEEP) and laser Conization: A 5-year follow-up study

Author

Giuseppe Sarpietro, Giovanni D'ippolito, Gabriele Carlinfante, Marco Petrillo, Claudia Brusadelli, Paola Carunchio, Maria Giovanna Salerno, Cono Scaffa, Arsenio Spinillo, Francesco Sopracordevole, Gian Franco Zannoni, Violante Di Donato, Francesco Plotti, Viola Liberale, Francesco Raspagliesi, Giovanni Scambia, Fabio Ghezzi, Antonino Ditto, Simona Ruisi, Michele Desiato, Ermelinda Monti, Valentina Chiappa, Pierandrea De Iaco, Stefano Greggi, Francesca Falcone, Lorenzo Aguzzoli, Roberto Angioli, Salvatore Dessole, Paolo Vercellini, Antonio Cianci, Gaetano Valenti, Giulia Dondi, Luca Giannella, Maurizio Serati, Andrea Giannini, Sara Bosio, Margherita Fischetti, Raffaele Tinelli, Tommaso Simoncini, Cristina Donfrancesco, Ludovico Muzii, Nicola Colacurci, Alessandro Ghelardi, Andrea Dell'Acqua, Ciro Pinelli, Salvatore Lopez, Rocco Guerrisi, Giorgio Bogani, Mauro Signorelli, Rosa De Vincenzo, Jvan Casarin, Pierluigi Benedetti Panici, Andrea Ciavattini, Lavinia Mosca, Umberto Leone Roberti Maggiore, Biagio Contino, Barbara Gardella, Vincenzo Dario Mandato, Mario Malzoni, Maria Grazia Matarazzo, Simone Ferrero, Gabriella Ferrandina, Anna Myriam Perrone, Chiara Borghi, Alice Bergamini, Bogani, G., DI DONATO, V., Sopracordevole, F., Ciavattini, A., Ghelardi, A., Lopez, S., Simoncini, T., Plotti, F., Casarin, J., Serati, M., Pinelli, C., Valenti, G., Bergamini, A., Gardella, B., Dell'Acqua, A., Monti, E., Vercellini, P., Fischetti, M., D'Ippolito, G., Aguzzoli, L., Mandato, V. D., Carunchio, P., Carlinfante, G., Giannella, L., Scaffa, C., Falcone, F., Borghi, C., Ditto, A., Malzoni, M., Giannini, A., Salerno, M. G., Liberale, V., Contino, B., Donfrancesco, C., Desiato, M., Perrone, A. M., Dondi, G., De IACO, P., LEONE ROBERTI MAGGIORE, U., Signorelli, M., Chiappa, V., Ferrero, S., Sarpietro, G., Matarazzo, M. G., Cianci, A., Bosio, S., Ruisi, S., Guerrisi, R., Brusadelli, C., Mosca, L., Tinelli, R., DE VINCENZO, R., Zannoni, G. F., Ferrandina, G., Petrillo, M., Dessole, S., Angioli, R., Greggi, S., Spinillo, A., Ghezzi, F., Colacurci, N., Muzii, L., BENEDETTI PANICI, P., Scambia, G., Raspagliesi, F., BOGANI G., DI DONATO V., SOPRACORDEVOLE F., CIAVATTINI A., GHELARDI A., LOPEZ S., SIMONCINI T., PLOTTI F., CASARIN J., SERATI M., PINELLI C., VALENTI G., BERGAMINI A., GARDELLA B., DELL'ACQUA A., MONTI E., VERCELLINI P., FISCHETTI M., D'IPPOLITO G., AGUZZOLI L., MANDATO V.D., CARUNCHIO P., CARLINFANTE G., GIANNELLA L., SCAFFA C., FALCONE F., BORGHI C., DITTO A., MALZONI M., GIANNINI A., SALERNO M.G., LIBERALE V., CONTINO B., DONFRANCESCO C., DESIATO M., PERRONE A.M., DONDI G., De IACO P., LEONE ROBERTI MAGGIORE U., SIGNORELLI M., CHIAPPA V., FERRERO S., SARPIETRO G., MATARAZZO M.G., CIANCI A., BOSIO S., RUISI S., GUERRISI R., BRUSADELLI C., MOSCA L., TINELLI R., DE VINCENZO R., ZANNONI G.F., FERRANDINA G., PETRILLO M., DESSOLE S., ANGIOLI R., GREGGI S., SPINILLO A., GHEZZI F., COLACURCI N., MUZII L., BENEDETTI PANICI P., SCAMBIA G., and RASPAGLIESI F.

Subjects
0301 basic medicine, Uterine Cervical Neoplasm, Neoplasm, Residual, Conization, Uterine Cervical Neoplasms, Cervix Uteri, Laser conization, Hpv persistence, Cervical dysplasia, 0302 clinical medicine, Risk Factors, Retrospective Studie, Aged, 80 and over, Medical record, Obstetrics and Gynecology, Margins of Excision, Middle Aged, Oncology, 030220 oncology & carcinogenesis, HPV, LEEP, Female, Human, Adult, medicine.medical_specialty, 5 year follow up, Adolescent, Electrosurgery, Laser, Follow-Up Studie, 03 medical and health sciences, Young Adult, medicine, Humans, In patient, Cervical Intraepithelial Neoplasia, Papillomavirus Infection, Retrospective Studies, Aged, business.industry, Lasers, Risk Factor, Papillomavirus Infections, Uterine Cervical Dysplasia, medicine.disease, Surgery, Settore MED/40 - GINECOLOGIA E OSTETRICIA, 030104 developmental biology, Uterine cervix, Increased risk, Dysplasia, Loop electrosurgical excision procedure, Neoplasm Grading, Neoplasm Recurrence, Local, business, Follow-Up Studies
Abstract

Objective: Conization aims to remove pre-neoplastic lesions of the uterine cervix. Several techniques for conization have been compared, but evidence regarding the most effective therapeutic option is scant. Here, we aimed to compare the recurrence rate following laser conization and loop electrosurgical excision procedure (LEEP) in patients with high-grade cervical dysplasia (HSIL/CIN2+). Methods: This is a retrospective multi-institutional study. Medical records of consecutive patients with HSIL/CIN2+ undergoing conization between 2010 and 2014 were retrieved. A propensity-score matching (PSM) was applied in order to reduce allocation bias. The risk of developing recurrence was estimated using Kaplan-Meir and Cox hazard models. Results: Overall, 2966 patients had conization over the study period, including 567 (20%) and 2399 (80%) patients having laser conization and LEEP, respectively. Looking at predictors of recurrence, diagnosis of CIN3 (HR:3.80 (95%CI:2.01,7.21); p < 0.001) and HPV persistence (HR:1.81 (95%CI:1.11,2.96); p < 0.001) correlated with an increased risk of recurrence. After applying a PSM we selected 500 patients undergoing laser conization and 1000 undergoing LEEP. Patients undergoing LEEP were at higher risk of having positive surgical margins in comparison to patients undergoing laser conization (11.2% vs. 4.2%). The risk of having persistence of HPV was similar between the two groups (15.0% vs. 11.6%;p = 0.256). Five-year recurrence rate was 8.1% and 4% after LEEP and laser conization, respectively (p = 0.023). HPV persistence was the only factor associated with [5-]year recurrence after both laser conization (p = 0.003) and LEEP (p = 0.001). Conclusions: HPV persistence is the only factor associated with an increased risk of recurrence after either laser conization or LEEP. Owing to the lack of data regarding obstetrical outcomes, we are not able to assess the best therapeutic option for women with cervical dysplasia.

Published
2020

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