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151. Safety and efficacy of rivaroxaban in pediatric cerebral venous thrombosis (EINSTEIN-Jr CVT).

Author

UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Service d'hématologie et d'oncologie pédiatrique, Connor, Philip, Sánchez van Kammen, Mayte, Lensing, Anthonie W A, Chalmers, Elizabeth, Kállay, Krisztián, Hege, Kerry, Simioni, Paolo, Biss, Tina, Bajolle, Fanny, Bonnet, Damien, Grunt, Sebastian, Kumar, Riten, Lvova, Olga, Bhat, Rukhmi, Van Damme, An, Palumbo, Joseph, Santamaria, Amparo, Saracco, Paola, Payne, Jeanette, Baird, Susan, Godder, Kamar, Labarque, Veerle, Male, Christoph, Martinelli, Ida, Morales Soto, Michelle, Motwani, Jayashree, Shah, Sanjay, Hooimeijer, Helene L, Prins, Martin H, Kubitza, Dagmar, Smith, William T, Berkowitz, Scott D, Pap, Akos F, Majumder, Madhurima, Monagle, Paul, Coutinho, Jonathan M, UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Service d'hématologie et d'oncologie pédiatrique, Connor, Philip, Sánchez van Kammen, Mayte, Lensing, Anthonie W A, Chalmers, Elizabeth, Kállay, Krisztián, Hege, Kerry, Simioni, Paolo, Biss, Tina, Bajolle, Fanny, Bonnet, Damien, Grunt, Sebastian, Kumar, Riten, Lvova, Olga, Bhat, Rukhmi, Van Damme, An, Palumbo, Joseph, Santamaria, Amparo, Saracco, Paola, Payne, Jeanette, Baird, Susan, Godder, Kamar, Labarque, Veerle, Male, Christoph, Martinelli, Ida, Morales Soto, Michelle, Motwani, Jayashree, Shah, Sanjay, Hooimeijer, Helene L, Prins, Martin H, Kubitza, Dagmar, Smith, William T, Berkowitz, Scott D, Pap, Akos F, Majumder, Madhurima, Monagle, Paul, and Coutinho, Jonathan M

Abstract

Anticoagulant treatment of pediatric cerebral venous thrombosis has not been evaluated in randomized trials. We evaluated the safety and efficacy of rivaroxaban and standard anticoagulants in the predefined subgroup of children with cerebral venous thrombosis (CVT) who participated in the EINSTEIN-Jr trial. Children with CVT were randomized (2:1), after initial heparinization, to treatment with rivaroxaban or standard anticoagulants (continued on heparin or switched to vitamin K antagonist). The main treatment period was 3 months. The primary efficacy outcome, symptomatic recurrent venous thromboembolism (VTE), and principal safety outcome, major or clinically relevant nonmajor bleeding,were centrally evaluated by blinded investigators. Sinus recanalization on repeat brain imaging was a secondary outcome. Statistical analyses were exploratory. In total, 114 children with confirmed CVT were randomized. All children completed the follow-up. None of the 73 rivaroxaban recipients and 1 (2.4%; CVT) of the 41 standard anticoagulant recipients had symptomatic, recurrent VTE after 3 months (absolute difference, 2.4%; 95% confidence interval [CI], -2.6% to 13.5%). Clinically relevant bleeding occurred in 5 (6.8%; all nonmajor and noncerebral) rivaroxaban recipients and in 1 (2.5%; major [subdural] bleeding) standard anticoagulant recipient (absolute difference, 4.4%; 95% CI, -6.7% to 13.4%). Complete or partial sinus recanalization occurred in 18 (25%) and 39 (53%) rivaroxaban recipients and in 6 (15%) and 24 (59%) standard anticoagulant recipients, respectively. In summary, in this substudy of a randomized trial with a limited sample size, children with CVT treated with rivaroxaban or standard anticoagulation had a low risk of recurrent VTE and clinically relevant bleeding. This trial was registered at clinicaltrials.gov as #NCT02234843.

Published
2020

152. Rivaroxaban compared with standard anticoagulants for the treatment of acute venous thromboembolism in children: a randomised, controlled, phase 3 trial

Author

Haematologie patientenzorg, Haematologie, Child Health, Cluster B, Male, Christoph, Lensing, Anthonie W. A., Palumbo, Joseph S., Kumar, Riten, Nurmeev, Ildar, Hege, Kerry, Bonnet, Damien, Connor, Philip, Hooimeijer, Helene L., Torres, Marcela, Chan, Anthony K. C., Kenet, Gili, Holzhauer, Susanne, Santamaria, Amparo, Amedro, Pascal, Chalmers, Elizabeth, Simioni, Paolo, Bhat, Rukhmi V., Yee, Donald L., Lvova, Olga, Beyer-Westendorf, Jan, Biss, Tina T., Martinelli, Ida, Saracco, Paola, Peters, Marjolein, Kallay, Krisztian, Gauger, Cynthia A., Massicotte, M. Patricia, Young, Guy, Pap, Akos F., Majumder, Madhurima, Smith, William T., Heubach, Jurgen F., Berkowitz, Scott D., Thelen, Kirstin, Kubitza, Dagmar, Crowther, Mark, Prins, Martin H., Monagle, Paul, EINSTEIN-Jr Phase 3 Investigators, Haematologie patientenzorg, Haematologie, Child Health, Cluster B, Male, Christoph, Lensing, Anthonie W. A., Palumbo, Joseph S., Kumar, Riten, Nurmeev, Ildar, Hege, Kerry, Bonnet, Damien, Connor, Philip, Hooimeijer, Helene L., Torres, Marcela, Chan, Anthony K. C., Kenet, Gili, Holzhauer, Susanne, Santamaria, Amparo, Amedro, Pascal, Chalmers, Elizabeth, Simioni, Paolo, Bhat, Rukhmi V., Yee, Donald L., Lvova, Olga, Beyer-Westendorf, Jan, Biss, Tina T., Martinelli, Ida, Saracco, Paola, Peters, Marjolein, Kallay, Krisztian, Gauger, Cynthia A., Massicotte, M. Patricia, Young, Guy, Pap, Akos F., Majumder, Madhurima, Smith, William T., Heubach, Jurgen F., Berkowitz, Scott D., Thelen, Kirstin, Kubitza, Dagmar, Crowther, Mark, Prins, Martin H., Monagle, Paul, and EINSTEIN-Jr Phase 3 Investigators

Published
2020

159. Contributors

Author

Ackerman, Veda L., primary, Adelson, P. David, additional, Agbeko, Rachel S., additional, Almodovar, Melvin C., additional, Alonso, Estella M., additional, Aneja, Raj K., additional, Angus, Derek C., additional, Argent, Andrew C., additional, Aspesberro, Francois P., additional, Bakar, Adnan M., additional, Bambach, Barbara, additional, Bass, Lee M., additional, Bayir, Hülya, additional, Beaulieu, Pierre, additional, Bell, Michael J., additional, Bender, M.A., additional, Benson, Jeffrey C., additional, Benton, Wade W., additional, Berg, Robert A., additional, Berkowitz, Darryl H., additional, Bhutta, Omar J., additional, Biagas, Katherine C., additional, Blatt, Julie, additional, Blowey, Douglas L., additional, Blumer, Jeffrey L., additional, Bradley, John S, additional, Brandom, Barbara W., additional, Brodsky, Linda, additional, Brogan, Thomas V., additional, Brothers, Adam W., additional, Bunchman, Timothy E., additional, Burd, Randall S., additional, Burns, Jeffrey, additional, Bush, Sean P., additional, Bystrak, Louis L., additional, Campbell, Angela J.P., additional, Cannavino, Christopher R., additional, Carcillo, Joseph A., additional, Carrillo-Lopez, Hector, additional, Cassara, Antonio, additional, Caty, Michael G., additional, Charpie, John R., additional, Chavez, Adrian, additional, Christenson, John C., additional, Clark, Jonna D., additional, Clark, Robert S.B., additional, Clement, Katherine C., additional, Coalson, Jacqueline J., additional, Coopersmith, Craig M., additional, Coppola, Christopher P., additional, Corey, Seth J., additional, Cox, Peter N., additional, Cummings, James J., additional, Curley, Martha A.Q., additional, Czosnyka, Marek, additional, D’Angelis, Christopher A., additional, Dahmer, Mary K., additional, Dalton, Heidi J., additional, Davis, Peter J., additional, Morena, M. Theresa de la, additional, Oliveira, Cláudio Flauzino de, additional, Dhanani, Sonny, additional, Dobyns, Emily L., additional, Donner, Elizabeth J., additional, Doughty, Lesley, additional, Dreyfuss, Didier, additional, Duncan, Christine, additional, Durand, Philippe, additional, Duthie, Susan, additional, Eigen, Howard, additional, Maamoun El-Dawy, Waleed M., additional, Elliott, Steven, additional, Emery, Helen M., additional, Escobar, Mauricio A., additional, Evans, Jacqueline M., additional, Felmet, Kate, additional, Fineman, Jeffrey R., additional, Fink, Ericka L., additional, Fiser, Richard T., additional, Fish, Frank A., additional, Fletcher, James E., additional, Forbes, Michael J., additional, Fort, Amber E., additional, Fost, Norman, additional, Frader, Joel E., additional, Franzon, Deborah E., additional, Fricker, F. Jay, additional, Friess, Stuart, additional, Fuhrman, Bradley P., additional, Garcia-Casal, Xiomara, additional, Gauvin, France, additional, Gaynor, J. William, additional, Gilad, Eli, additional, Gilbert, James C., additional, Glaser, Nicole S., additional, Goldstein, Stuart L., additional, Goodman, Denise M., additional, Graciano, Ana Lía, additional, Gunnarsson, Björn, additional, Hahn, Cecil D., additional, Hall, Mark, additional, Hamilton, Melinda Fiedor, additional, Han, Yong Y., additional, Hanson, Cherissa, additional, Harding, Cary O., additional, Hartman, Mary E., additional, Hazelzet, Jan A., additional, Heard, Christopher M.B., additional, Heine, Ann Marie, additional, Hernan, Lynn J., additional, Hertzig, Jeremy S., additional, Heulitt, Mark J., additional, Hoffman, Julien I.E., additional, Huhta, James C., additional, Ichord, Rebecca, additional, Inglis, Andrew, additional, Linggi Irby, Gretchen A., additional, Jacobs, Brian, additional, Jardine, David, additional, Jarillo-Quijada, Alberto, additional, Javouey, Etienne, additional, Jefferis Kirk, Christa C., additional, Johns, James A., additional, Joshi, Prashant, additional, Kagan, Richard J., additional, Kannankeril, Prince J., additional, Kanter, Robert K., additional, Karam, Oliver, additional, Kasten, Kevin R., additional, Kelly, Michael, additional, Khanna, Paritosh C., additional, Kochanek, Patrick M., additional, Kocis, Keith C., additional, Kocoshis, Samuel A., additional, Koves, Ildiko H., additional, Kulik, Thomas J., additional, Kumar, Vasanth H., additional, Lacroix, Jacques, additional, Lakshminrusimha, Satyan, additional, Langley, Joanne M., additional, Laussen, Peter C., additional, Levin, Daniel L., additional, Lewis-Newby, Mithya, additional, Lieh-Lai, Mary W., additional, Lindsey, Daphne, additional, Litalien, Catherine, additional, Lynch, Robert E., additional, Makley, Amy T., additional, Marcin, James P., additional, Mariscalco, Mary Michele, additional, Markovitz, Barry, additional, Martin, Lynn D., additional, Maxvold, Norma J., additional, Mazur, Paula M., additional, McArthur, Jennifer A., additional, McLaughlin, Jerry, additional, McLaughlin, Gwenn E., additional, Redwine, Karen McNiece, additional, Mehta, Nilesh M., additional, Mehta, Renuka, additional, Melvin, Ann J., additional, Menon, Sharad, additional, Mian, Ayesa N., additional, Michelson, Kelly, additional, Michienzi, Kelly A., additional, Moloney-Harmon, Patricia A., additional, Monagle, Paul, additional, Moss, Michele M., additional, Mou, Steven S., additional, Muenzer, Jared T., additional, Nadkarni, Vinay, additional, Nakagawa, Thomas A., additional, Naran, Navyn, additional, Nguyen, Trung, additional, Nicholson, Carol E., additional, Nielsen, Katie R., additional, Northway, Tracie, additional, Norwood, Victoria F., additional, Notterman, Daniel A., additional, Nowak, Jeffrey E., additional, Oishi, Peter, additional, Orr, Richard A., additional, Ouellette, Yves, additional, Parakininkas, Daiva, additional, Parker, Margaret M., additional, Pearson-Shaver, Tony, additional, Pérez Fontán, J. Julio, additional, Peters, Mark, additional, Pihoker, Catherine, additional, Pinsk, Maury N., additional, Pollack, Murray M., additional, Pon, Steven, additional, Quasney, Michael, additional, Rajasekaran, Surender, additional, Rampersad, Sally E., additional, Ranjit, Suchitra, additional, Reade, Erin P., additional, Reese Jr., James J., additional, Relvas, Monica, additional, Remy, Kenneth E., additional, Ricard, Jean-Damien, additional, Rice, Tom B., additional, Ridling, Debra Ann, additional, Roberts, Joan S., additional, Ross, Ashley S., additional, Roth, Kimberly R., additional, Rotta, Alexandre T., additional, Rowin, Mark E., additional, Roy, John, additional, Rubino, Christopher M., additional, Ruppel, Randall A., additional, Rushton, Cynda H., additional, Ryan, Rita M., additional, Salonia, Rosanne, additional, Salvin, Joshua, additional, Sanders Jr., Ronald C., additional, Sarnaik, Ajit A., additional, Sarnaik, Ashok P., additional, Saumon, Georges, additional, Sawin, Robert, additional, Scanlon, Matthew C., additional, Schenkman, Kenneth A., additional, Schexnayder, Stephen M., additional, Schleien, Charles L., additional, Schwartz, George J., additional, Schwartz, Steven M., additional, Shann, Frank, additional, Shaw, Dennis W.W., additional, Shemie, Sam D., additional, Shoykhet, Mish, additional, Sivarajan, V. Ben, additional, Skippen, Peter W., additional, Slonim, Anthony D., additional, Smith, Laurie, additional, Smith, Lincoln S., additional, Standage, Stephen W., additional, Steinberg, Joel B., additional, Steinhorn, David M., additional, Stojanovski, Sasko D., additional, Storm, Elizabeth A., additional, Stroud, Michael H., additional, Sturgill, Marc G., additional, Sutton, Robert M., additional, Symons, Jordan M., additional, Tailounie, Muayyad, additional, Talano, Julie-An, additional, Tamburro Jr., Robert, additional, Tasker, Robert C., additional, Thompson, Ann E., additional, Tilton, Ann H., additional, Tinmouth, Alan, additional, Tobias, Joseph D., additional, Tobin, Nicole H., additional, Todres, I. David, additional, Tucci, Marisa, additional, Ulate, Kalia P., additional, Valentine, Kevin M., additional, Vaughan, David J., additional, Venkataraman, Shekhar T., additional, Visoiu, Mihaela, additional, von Saint André–von Arnim, Amélie, additional, Wainwright, Mark S., additional, Wakeham, Martin K., additional, Watson, R. Scott, additional, Webb, Ashley N., additional, Weigle, Carl, additional, Weimer, Maria B., additional, Wessel, David L., additional, Wetzel, Randall C., additional, Wong, Hector R., additional, Wood, Ellen G., additional, Woolf, Alan D., additional, Woytash, James J., additional, Yanay, Ofer, additional, Zaritsky, Arno, additional, Zerr, Danielle M., additional, and Zimmerman, Jerry J., additional

Published
2011
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175. Impact of Persistent Antiphospholipid Antibodies on Risk of Incident Symptomatic Thromboembolism in Children: A Systematic Review and Meta-Analysis

Author

Kenet, Gili, Aronis, Sofia, Berkun, Yackov, Bonduel, Mariana, Chan, Anthony, Goldenberg, Neil A., Holzhauer, Susanne, Iorio, Alfonso, Journeycake, Janna, Junker, Ralf, Male, Christoph, Manco-Johnson, Marilyn, Massicotte, Patti, Mesters, Rolf, Monagle, Paul, van Ommen, Heleen, Rafini, Leslie, Simioni, Paolo, Young, Guy, and Nowak-Göttl, Ulrike

Published
2011

180. Consensus‐based clinical recommendations and research priorities for anticoagulant thromboprophylaxis in children hospitalized for COVID‐19–related illness

Author

Goldenberg, Neil A., primary, Sochet, Anthony, additional, Albisetti, Manuela, additional, Biss, Tina, additional, Bonduel, Mariana, additional, Jaffray, Julie, additional, MacLaren, Graeme, additional, Monagle, Paul, additional, O’Brien, Sarah, additional, Raffini, Leslie, additional, Revel‐Vilk, Shoshana, additional, Sirachainan, Nongnuch, additional, Williams, Suzan, additional, Zia, Ayesha, additional, and Male, Christoph, additional

Published
2020
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186. Methodology for the American Society of Hematology VTE guidelines: current best practice, innovations, and experiences

Author

Wiercioch, Wojtek, primary, Nieuwlaat, Robby, primary, Akl, Elie A., primary, Kunkle, Robert, primary, Alexander, Kendall E., primary, Cuker, Adam, primary, Rajasekhar, Anita, primary, Alonso-Coello, Pablo, primary, Anderson, David R., primary, Bates, Shannon M., primary, Cushman, Mary, primary, Dahm, Philipp, primary, Guyatt, Gordon, primary, Iorio, Alfonso, primary, Lim, Wendy, primary, Lyman, Gary H., primary, Middeldorp, Saskia, primary, Monagle, Paul, primary, Mustafa, Reem A., primary, Neumann, Ignacio, primary, Ortel, Thomas L., primary, Rochwerg, Bram, primary, Santesso, Nancy, primary, Vesely, Sara K., primary, Witt, Daniel M., primary, and Schünemann, Holger J., primary

Published
2020
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194. Defining the path ahead for NOAC use in the pediatric population: A cardiac safety research consortium think tank

Author

Seltzer, Jonathan H., primary, Farrell, Ann, additional, Goldenberg, Neil, additional, Hornik, Christoph, additional, Keene, Daniel, additional, Krucoff MD, Mitchell W., additional, Lipardi, Concetta, additional, Massicotte, Patricia, additional, Mentzer, Dirk, additional, Monagle, Paul, additional, Thornburg, Courtney, additional, Revkin, James H., additional, Walker, Shetarra, additional, and Gajjar, Diptee, additional

Published
2020
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196. Management of People With a Fontan Circulation: a Cardiac Society of Australia and New Zealand Position statement

Author

Zentner, Dominica, primary, Celermajer, David S., additional, Gentles, Thomas, additional, d’Udekem, Yves, additional, Ayer, Julian, additional, Blue, Gillian M., additional, Bridgman, Cameron, additional, Burchill, Luke, additional, Cheung, Michael, additional, Cordina, Rachael, additional, Culnane, Evelyn, additional, Davis, Andrew, additional, du Plessis, Karin, additional, Eagleson, Karen, additional, Finucane, Kirsten, additional, Frank, Belinda, additional, Greenway, Sebastian, additional, Grigg, Leeanne, additional, Hardikar, Winita, additional, Hornung, Tim, additional, Hynson, Jenny, additional, Iyengar, Ajay J., additional, James, Paul, additional, Justo, Robert, additional, Kalman, Jonathan, additional, Kasparian, Nadine, additional, Le, Brian, additional, Marshall, Kate, additional, Mathew, Jacob, additional, McGiffin, David, additional, McGuire, Mark, additional, Monagle, Paul, additional, Moore, Ben, additional, Neilsen, Julie, additional, O’Connor, Bernadette, additional, O’Donnell, Clare, additional, Pflaumer, Andreas, additional, Rice, Kathryn, additional, Sholler, Gary, additional, Skinner, Jonathan R., additional, Sood, Siddharth, additional, Ward, Juliet, additional, Weintraub, Robert, additional, Wilson, Tom, additional, Wilson, William, additional, Winlaw, David, additional, and Wood, Angela, additional

Published
2020
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197. Rivaroxaban compared with standard anticoagulants for the treatment of acute venous thromboembolism in children: a randomised, controlled, phase 3 trial

Author

Male, Christoph, primary, Lensing, Anthonie W A, additional, Palumbo, Joseph S, additional, Kumar, Riten, additional, Nurmeev, Ildar, additional, Hege, Kerry, additional, Bonnet, Damien, additional, Connor, Philip, additional, Hooimeijer, Hélène L, additional, Torres, Marcela, additional, Chan, Anthony K C, additional, Kenet, Gili, additional, Holzhauer, Susanne, additional, Santamaría, Amparo, additional, Amedro, Pascal, additional, Chalmers, Elizabeth, additional, Simioni, Paolo, additional, Bhat, Rukhmi V, additional, Yee, Donald L, additional, Lvova, Olga, additional, Beyer-Westendorf, Jan, additional, Biss, Tina T, additional, Martinelli, Ida, additional, Saracco, Paola, additional, Peters, Marjolein, additional, Kállay, Krisztián, additional, Gauger, Cynthia A, additional, Massicotte, M Patricia, additional, Young, Guy, additional, Pap, Akos F, additional, Majumder, Madhurima, additional, Smith, William T, additional, Heubach, Jürgen F, additional, Berkowitz, Scott D, additional, Thelen, Kirstin, additional, Kubitza, Dagmar, additional, Crowther, Mark, additional, Prins, Martin H, additional, Monagle, Paul, additional, Molinari, Angelo C., additional, Nowak Göttl, Ulrike, additional, Chain, Juan, additional, Robertson, Jeremy, additional, Thom, Katharina, additional, Streif, Werner, additional, Schwarz, Rudolf, additional, Schmitt, Klaus, additional, Grangl, Gernot, additional, Van Damme, An, additional, Maes, Philip, additional, Labarque, Veerle, additional, Petrilli, Antonio, additional, Loggeto, Sandra, additional, Azeka, Estela, additional, Brandao, Leonardo, additional, Le, Doan, additional, Sabapathy, Christine, additional, Giordano, Paola, additional, Wu, Runhui, additional, Ding, Jie, additional, Huang, Wenyan, additional, Mao, Jianhua, additional, Lähteenmäki, Päivi, additional, Decramer, Stephane, additional, Bernig, Toralf, additional, Chada, Martin, additional, Chan, Godfrey, additional, Kally, Krisztian, additional, Nolan, Beatrice, additional, Revel-Vilk, Shoshana, additional, Tamary, Hannah, additional, Levin, Carina, additional, Tormene, Daniela, additional, Abbattista, Maria, additional, Artoni, Andrea, additional, Ikeyama, Takanari, additional, Inuzuka, Ryo, additional, Yasukochi, Satoshi, additional, Morales Soto, Michelle, additional, Solis Labastida, Karina A, additional, Suijker, Monique H, additional, Bartels, Marike, additional, Tamminga, Rienk Y, additional, Van Ommen, C Heleen, additional, Te Loo, D. Maroeska, additional, Anjos, Rui, additional, Zubarovskaya, Lyudmila, additional, Popova, Natalia, additional, Samochatova, Elena, additional, Belogurova, Margarita, additional, Svirin, Pavel, additional, Shutova, Tatiana, additional, Lebedev, Vladimir, additional, Barbarash, Olga, additional, Koh, Pei L, additional, Mei, Joyce C, additional, Podracka, Ludmila, additional, Berrueco, Ruben, additional, Fernandez, Maria F, additional, Frisk, Tony, additional, Grunt, Sebastian, additional, Rischewski, Johannes, additional, Albisetti-Pedroni, Manuela, additional, Antmen, Ali, additional, Tokgoz, Huseyin, additional, Karakas, Zeynep, additional, Motwani, Jayashree, additional, Williams, Michael, additional, Grainger, John, additional, Payne, Jeanette, additional, Richards, Mike, additional, Baird, Susan, additional, Bhatnagar, Neha, additional, Aramburo, Angela, additional, Crary, Shelley, additional, Wynn, Tung, additional, Carpenter, Shannon, additional, Ahuja, Sanjay, additional, Goldenberg, Neil, additional, Woods, Gary, additional, Godder, Kamar, additional, Scott-Emuakpor, Ajovi, additional, Roach, Gavin, additional, Raffini, Leslie, additional, Shah, Nirmish, additional, Shah, Sanjay, additional, Thornburg, Courtney, additional, Zia, Ayesha, additional, and Berkow, Roger, additional

Published
2020
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