Regulatory inventory and regulatory change management framework von Dodge Jason Dane, Galligan Davila Kelly Ann, McRae Walter Eugene, Snyder Richard Allen, Rapaka Srinivas, Moore Ethan Thomas, LaPrade Ryan Alexander

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REGULATORY INVENTORY AND REGULATORY CHANGE MANAGEMENT FRAMEWORK von SNYDER RICHARD ALLEN, LAPRADE RYAN ALEXANDER, DODGE JASON DANE, MOORE ETHAN THOMAS, RAPAKA SRINIVAS, MCRAE WALTER EUGENE, GALLIGAN DAVILA KELLY ANN

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AACR Project GENIE: Powering Precision Medicine through an International Consortium von André, Fabrice, Arnedos, Monica, Baras, Alexander S., Baselga, José, Bedard, Philippe L., Berger, Michael F., Bierkens, Mariska, Calvo, Fabien, Cerami, Ethan, Chakravarty, Debyani, Dang, Kristen K., Davidson, Nancy E., Del Vecchio Fitz, Catherine, Dogan, Semih, DuBois, Raymond N., Ducar, Matthew D., Futreal, P. Andrew, Gao, Jianjiong, Garcia, Francisco, Gardos, Stu, Gocke, Christopher D., Gross, Benjamin E., Guinney, Justin, Heins, Zachary J., Hintzen, Stephanie, Horlings, Hugo, Hudeček, Jan, Hyman, David M., Kamel-Reid, Suzanne, Kandoth, Cyriac, Kinyua, Walter, Kumari, Priti, Kundra, Ritika, Ladanyi, Marc, Lefebvre, Céline, LeNoue-Newton, Michele L., Lepisto, Eva M., Levy, Mia A., Lindeman, Neal I., Lindsay, James, Liu, David, Lu, Zhibin, MacConaill, Laura E., Maurer, Ian, Maxwell, David S., Meijer, Gerrit A., Meric-Bernstam, Funda, Micheel, Christine M., Miller, Clinton, Mills, Gordon, Moore, Nathanael D., Nederlof, Petra M., Omberg, Larsson, Orechia, John A., Park, Ben Ho, Pugh, Trevor J., Reardon, Brendan, Rollins, Barrett J., Routbort, Mark J., Sawyers, Charles L., Schrag, Deborah, Schultz, Nikolaus, Shaw, Kenna R Mills, Shivdasani, Priyanka, Siu, Lillian L., Solit, David B., Sonke, Gabe S., Soria, Jean Charles, Sripakdeevong, Parin, Stickle, Natalie H., Stricker, Thomas P., Sweeney, Shawn M., Taylor, Barry S., ten Hoeve, Jelle J., Thomas, Stacy B., Van Allen, Eliezer M., Van 'T Veer, Laura J., van de Velde, Tony, van Tinteren, Harm, Velculescu, Victor E., Virtanen, Carl, Voest, Emile E., Wang, Lucy L., Wathoo, Chetna, Watt, Stuart, Yu, Celeste, Yu, Thomas V., Yu, Emily, Zehir, Ahmet, Zhang, Hongxin

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Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chem... von Basch, Ethan, Pugh, Stephanie L., Dueck, Amylou C., Mitchell, Sandra A., Berk, Lawrence, Fogh, Shannon, Rogak, Lauren J., Gatewood, Marcha, Reeve, Bryce B., Mendoza, Tito R., O'Mara, Ann M., Denicoff, Andrea M., Minasian, Lori M., Bennett, Antonia V., Setser, Ann, Schrag, Deborah, Roof, Kevin, Moore, Joan K., Gergel, Thomas, Stephans, Kevin, Rimner, Andreas, DeNittis, Albert, Bruner, Deborah Watkins

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Antibacterial Envelope to Prevent Cardiac Implantable Device Infection von Tarakji, Khaldoun G, Mittal, Suneet, Kennergren, Charles, Corey, Ralph, Poole, Jeanne E, Schloss, Edward, Gallastegui, Jose, Pickett, Robert A, Evonich, Rudolph, Philippon, François, McComb, Janet M, Roark, Steven F, Sorrentino, Denise, Sholevar, Darius, Cronin, Edmond, Berman, Brett, Riggio, David, Biffi, Mauro, Khan, Hafiza, Silver, Marc T, Collier, Jack, Eldadah, Zayd, Wright, David J, Lande, Jeff D, Lexcen, Daniel R, Cheng, Alan, Wilkoff, Bruce L

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Author Correction: Continent-wide tree fecundity driven by indirect climate effects von Clark, James S., Andrus, Robert, Aubry-Kientz, Melaine, Bergeron, Yves, Bogdziewicz, Michal, Bragg, Don C., Brockway, Dale, Cleavitt, Natalie L., Cohen, Susan, Courbaud, Benoit, Daley, Robert, Das, Adrian J., Dietze, Michael, Fahey, Timothy J., Fer, Istem, Franklin, Jerry F., Gehring, Catherine A., Gilbert, Gregory S., Greenberg, Cathryn H., Guo, Qinfeng, HilleRisLambers, Janneke, Ibanez, Ines, Johnstone, Jill, Kilner, Christopher L., Knops, Johannes, Koenig, Walter D., Kunstler, Georges, LaMontagne, Jalene M., Legg, Kristin L., Luongo, Jordan, Lutz, James A., Macias, Diana, McIntire, Eliot J. B., Messaoud, Yassine, Moore, Christopher M., Moran, Emily, Myers, Jonathan A., Myers, Orrin B., Nunez, Chase, Parmenter, Robert, Pearse, Sam, Pearson, Scott, Poulton-Kamakura, Renata, Ready, Ethan, Redmond, Miranda D., Reid, Chantal D., Rodman, Kyle C., Scher, C. Lane, Schlesinger, William H., Schwantes, Amanda M., Shanahan, Erin, Sharma, Shubhi, Steele, Michael A., Stephenson, Nathan L., Sutton, Samantha, Swenson, Jennifer J., Swift, Margaret, Veblen, Thomas T., Whipple, Amy V., Whitham, Thomas G., Wion, Andreas P., Zhu, Kai, Zlotin, Roman

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Multiscale optimization of formic acid dehydrogenation process via linear model decision tree surrogates von Sunshine, Ethan M., Bucci, Giovanna, Chatterjee, Tanusree, Deo, Shyam, Ehlinger, Victoria M., Li, Wenqin, Moore, Thomas, Myers, Corey, Sun, Wenyu, Wang, Bo-Xun, Yuan, Mengyao, Kitchin, John R., Laird, Carl D., McNenly, Matthew J., Akhade, Sneha A.

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Trauma Hemostasis and Oxygenation Research Network position paper on the role of hypotensive resuscitation as part of remote damage control resuscitation von Woolley, Thomas, Thompson, Patrick, Kirkman, Emrys, Reed, Richard, Ausset, Sylvain, Beckett, Andrew, Bjerkvig, Christopher, Cap, Andrew P, Coats, Tim, Cohen, Mitchell, Despasquale, Marc, Dorlac, Warren, Doughty, Heidi, Dutton, Richard, Eastridge, Brian, Glassberg, Elon, Hudson, Anthony, Jenkins, Donald, Keenan, Sean, Martinaud, Christophe, Miles, Ethan, Moore, Ernest, Nordmann, Giles, Prat, Nicolas, Rappold, Joseph, Reade, Michael C, Rees, Paul, Rickard, Rory, Schreiber, Martin, Shackelford, Stacy, Skogran Eliassen, Håkon, Smith, Jason, Smith, Mike, Spinella, Philip, Strandenes, Geir, Ward, Kevin, Watts, Sarah, White, Nathan, Williams, Steve

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Hemorrhagic Resuscitation Guided by Viscoelastography in Far-Forward Combat and Austere Civilian Environments: Goal-Directed Whole-Blood and Blood-Component Therapy Far from the Tr... von Lantry, James H, Mason, Phillip, Logsdon, Matthew G, Bunch, Connor M, Peck, Ethan E, Moore, Ernest E, Moore, Hunter B, Neal, Matthew D, Thomas, Scott G, Khan, Rashid Z, Gillespie, Laura, Florance, Charles, Korzan, Josh, Preuss, Fletcher R, Mason, Dan, Saleh, Tarek, Marsee, Mathew K, Vande Lune, Stefani, Ayoub, Qamarnisa, Fries, Dietmar, Walsh, Mark M

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Perioperative thrombotic complications associated with pediatric liver transplantation: a UNOS database evaluation von Bezinover, Dmitri, Deacutis, Molly F., Dalal, Priti G., Moore, Robert P., Stine, Jonathan G., Wang, Ming, Reeder, Ethan, Hollenbeak, Christopher S., Saner, Fuat H., Riley, Thomas R., Janicki, Piotr K.

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Climatizing the internal medicine residency curriculum: A practical guide for integrating the topic of climate and health into resident education von Kuczmarski, Thomas M., Fox, Jacob, Katznelson, Ethan, Thakral, Durga, Aung, Khin-Kyemon, Moore, Emily, Eisen, Jonathan, Slutzman, Jonathan E, LaRocque, Regina, Solomon, Caren G, Furie, Gregg L, Dellaripa, Paul F

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Retrospective analysis of infliximab and adalimumab treatment in a large cohort of juvenile dermatomyositis patients von Campanilho-Marques, Raquel, Deakin, Claire T, Simou, Stefania, Papadopoulou, Charalampia, Wedderburn, Lucy R, Pilkington, Clarissa A

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TIF1-gamma IgG2 isotype is not associated with malignancy in juvenile dermatomyositis patients von Nguyen, Huong D, Jouen, Fabienne, Déchelotte, Benoit, Cordel, Nadège, Gitiaux, Cyril, Bodemer, Christine, Quartier, Pierre, Belot, Alexandre, O'Brien, Kathryn, Cancemi, Dario, Melki, Isabelle, Fabien, Nicole, Tansley, Sarah, Boyer, Olivier, Wedderburn, Lucy R, Bader-Meunier, Brigitte

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Histological heterogeneity in a large clinical cohort of juvenile idiopathic inflammatory myopathy: analysis by myositis autoantibody and pathological features von Yasin, S. A., Schutz, P. W., Deakin, C. T., Sag, E., Simou, S., Marshall, L. R., Tansley, S. L., McHugh, N. J., Holton, J. L., Wedderburn, L. R., Jacques, T. S., Armon, Kate, Ellis‐Gage, Joe, Briggs, Vanja, Watts, Joanna, McCann, Liza, Roberts, Ian, Baildam, Eileen, Hanna, Lou, Lloyd, Olivia, Wadeson, Susan, Riley, Phil, McGovern, Ann, Ryder, Clive, Scott, Janis, Thomas, Beverley, Southwood, Taunton, Al‐Abadi, Eslam, Wyatt, Sue, Jackson, Gillian, Wood, Mark, VanRooyen, Vanessa, Burton, Deborah, Davidson, Joyce, Gardner‐Medwin, Janet, Martin, Neil, Waxman, Liz, Browne, Michael, Friswell, Mark, Foster, Helen, Swift, Alison, Stevenson, Vicky, Wade, Debbie, Sen, Ethan, Smith, Eve, Qiao, Lisa, Watson, Stuart, Duong, Claire, Venning, Helen, Satyapal, Rangaraj, Stretton, Elizabeth, Jordan, Mary, Mosley, Ellen, Frost, Anna, Crate, Lindsay, Warrier, Kishore, ord, Stefanie, Pilkington, Clarissa, Hasson, Nathan, Halkon, Elizabeth, Brown, Virginia, Juggins, Audrey, Smith, Sally, Lunt, Sian, Enayat, Elli, Kassoumeri, Laura, Beard, Laura, Arnold, Katie, Glackin, Yvonne, Simou, Stephanie, Almeida, Beverley, Nistala, Kiran, Dowle, Stefanie, Papadopoulou, Charis, Johnson‐Moore, Cer, Robinson, Emily, Murray, Kevin, Ioannou, John, Suffield, Linda, Al‐Obaidi, Muthana, Lee, Helen, Leach, Sam, McMahon, Anne‐Marie, Chisem, Heather, Kingshott, Ruth, Wilkinson, Nick, Inness, Emma, Kendall, Eunice, Mayers, David, Bailey, Kathryn, Fineman, Natalie, Pluess‐Hall, Helen, Akeroyd, Lou, Leahy, Alice, Collier, Amy, Cutts, Rebecca, Macleod, Emma, De Graaf, Hans, Hartfree, Sarah, Pratt, Danny

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Efficacy and Safety of Cyclophosphamide Treatment in Severe Juvenile Dermatomyositis Shown by Marginal Structural Modeling von Deakin, Claire T., Campanilho‐Marques, Raquel, Simou, Stefania, Moraitis, Elena, Wedderburn, Lucy R., Pilkington, Clarissa A., Armon, Kate, Ellis‐Gage, Joe, Roper, Holly, Briggs, Vanja, Watts, Joanna, McCann, Liza, Roberts, Ian, Baildam, Eileen, Hanna, Louise, Lloyd, Olivia, Wadeson, Susan, Riley, Phil, McGovern, Ann, Ryder, Clive, Thomas, Beverley, Southwood, Taunton, Al‐Abadi, Eslam, Wyatt, Sue, Amin, Tania, VanRooyen, Vanessa, Burton, Deborah, Davidson, Joyce, Gardner‐Medwin, Janet, Martin, Neil, Ferguson, Sue, Waxman, Liz, Browne, Michael, Friswell, Mark, Swift, Alison, Jandial, Sharmila, Stevenson, Vicky, Wade, Debbie, Sen, Ethan, Smith, Eve, Watson, Stuart, Duong, Claire, Venning, Helen, Satyapal, Rangaraj, Stretton, Elizabeth, Jordan, Mary, Mosley, Ellen, Frost, Anna, Crate, Lindsay, Warrier, Kishore, Stafford, Stefanie, Wedderburn, Lucy, Hasson, Nathan, Maillard, Sue, Halkon, Elizabeth, Brown, Virginia, Juggins, Audrey, Smith, Sally, Lunt, Sian, Enayat, Elli, Varsani, Hemlata, Beard, Laura, Arnold, Katie, Glackin, Yvonne, Simou, Stephanie, Almeida, Beverley, Nistala, Kiran, Yasin, Shireena, Marques, Raquel, Deakin, Claire, Dowle, Stefanie, Papadopoulou, Charis, Johnson‐Moore, Cerise, Robinson, Emily, Murray, Kevin, Ioannou, John, Suffield, Linda, Al‐Obaidi, Muthana, Lee, Helen, Smith, Helen, McMahon, Anne‐Marie, Chisem, Heather, Wilkinson, Nick, Inness, Emma, Mayers, David, Etherton, Ruth, Bailey, Kathryn, Clinch, Jacqui, Fineman, Natalie, Pluess‐Hall, Helen, Vallance, Lindsay, Akeroyd, Louise, Leahy, Alice, Collier, Amy, Cutts, Rebecca, Macleod, Emma, De Graaf, Hans, Davidson, Brian, Hartfree, Sarah, Pratt, Danny

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Community based distribution of oral HIV self-testing kits in Zambia: a cluster-randomised trial nested in four HPTN 071 (PopART) intervention communities von Mulubwa, Chama, Hensen, Bernadette, Phiri, Mwelwa M, Shanaube, Kwame, Schaap, Albertus J, Floyd, Sian, Phiri, Comfort R, Bwalya, Chiti, Bond, Virginia, Simwinga, Musonda, Mwenge, Lawrence, Fidler, Sarah, Hayes, Richard, Mwinga, Alwyn, Ayles, Helen

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Impact of stratospheric air and surface emissions on tropospheric nitrous oxide during ATom von Gonzalez, Yenny, Commane, Róisín, Manninen, Ethan, Daube, Bruce C, Schiferl, Luke D, McManus, J. Barry, McKain, Kathryn, Hintsa, Eric J, Elkins, James W, Montzka, Stephen A, Sweeney, Colm, Moore, Fred, Jimenez, Jose L, Campuzano Jost, Pedro, Ryerson, Thomas B, Bourgeois, Ilann, Peischl, Jeff, Thompson, Chelsea R, Ray, Eric, Wennberg, Paul O, Crounse, John, Kim, Michelle, Allen, Hannah M, Newman, Paul A, Stephens, Britton B, Apel, Eric C, Hornbrook, Rebecca S, Nault, Benjamin A, Morgan, Eric, Wofsy, Steven C

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Rationale and Design for the BLOCK-SAH Study (Pterygopalatine Fossa Block as an Opioid-Sparing Treatment for Acute Headache in Aneurysmal Subarachnoid Hemorrhage): A Phase II, Mult... von Busl, Katharina M, Smith, Cameron R, Troxel, Andrea B, Fava, Maurizio, Illenberger, Nicholas, Pop, Ralisa, Yang, Wenqing, Frota, Luciola Martins, Gao, Hanzhi, Shan, Guogen, Hoh, Brian L, Maciel, Carolina B

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Feasibility of Patient Reporting of Symptomatic Adverse Events via the PRO-CTCAE in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial von Basch, Ethan, MD, Pugh, Stephanie L., PhD, Dueck, Amylou C., PhD, Mitchell, Sandra A., PhD, Berk, Lawrence, MD, PhD, Fogh, Shannon, MD, Rogak, Lauren J., MA, Gatewood, Marcha, MBA, Reeve, Bryce B., PhD, Mendoza, Tito R., PhD, O’Mara, Ann, PhD, Denicoff, Andrea, RN, MS, Minasian, Lori, MD, Bennett, Antonia V., PhD, Setser, Ann, BSN, MEd, Schrag, Deborah, MD, MPH, Roof, Kevin, MD, Moore, Joan K., RN, MSN, OCN, CCRP, Gergel, Thomas, MD, Stephans, Kevin, MD, Rimner, Andreas, MD, DeNittis, Albert, MD, Bruner, Deborah Watkins, PhD

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Demographics of sources of HIV-1 transmission in Zambia: a molecular epidemiology analysis in the HPTN 071 PopART study von Hall, Matthew, Golubchik, Tanya, Bonsall, David, Abeler-Dörner, Lucie, Limbada, Mohammed, Kosloff, Barry, Schaap, Ab, de Cesare, Mariateresa, MacIntyre-Cockett, George, Otecko, Newton, Probert, William, Ratmann, Oliver, Bulas Cruz, Ana, Piwowar-Manning, Estelle, Burns, David N, Cohen, Myron S, Donnell, Deborah J, Eshleman, Susan H, Simwinga, Musonda, Fidler, Sarah, Hayes, Richard, Ayles, Helen, Fraser, Christophe

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