Regulatory news: Dojolvi (triheptanoin) as a source of calories and fatty acids in long‐chain fatty acid oxidation disorders: FDA approval summary von Zand, Dina, Doan, Jenny, Yi, Sojeong, Wang, Jie, Ma, Lian, Akinshola, Emmanuel, Chakder, Sushanta, Meyer, Joette, Pacanowski, Michael, Johnson, Laura Lee, Donohue, Kathleen, Beitz, Julie

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Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections von Kim, Janice, Singh, Harpreet, Ayalew, Kassa, Borror, Kristina, Campbell, Michelle, Johnson, Laura Lee, Karesh, Alyson, Khin, Ni A, Less, Joanne R, Menikoff, Jerry, Minasian, Lori, Mitchell, Sandra A, Papadopoulos, Elektra J, Piekarz, Richard L, Prohaska, Kevin A, Thompson, Susan, Sridhara, Rajeshwari, Pazdur, Richard, Kluetz, Paul G

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Total and Cancer Mortality After Supplementation With Vitamins and Minerals: Follow-up of the Linxian General Population Nutrition Intervention Trial von Qiao, You-Lin, Dawsey, Sanford M., Kamangar, Farin, Fan, Jin-Hu, Abnet, Christian C., Sun, Xiu-Di, Johnson, Laura Lee, Gail, Mitchell H., Dong, Zhi-Wei, Yu, Binbing, Mark, Steven D., Taylor, Philip R.

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Aryl Hydrocarbon Receptor Expression Is Associated with a Family History of Upper Gastrointestinal Tract Cancer in a High-Risk Population Exposed to Aromatic Hydrocarbons von ROTH, Mark J, WEI, Wen-Qiang, DAWSEY, Sanford M, QIAO, You-Lin, CHERRY, James, BAER, Jessica, ABNET, Christian C, WANG, Guo-Qing, STEMBERG, Lawrence R, WARMER, Andrew C, LEE JOHNSON, Laura, LU, Ning, GIFFEN, Carol A

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NCCAM/NCI Phase 1 Study of Mistletoe Extract and Gemcitabine in Patients with Advanced Solid Tumors von Mansky, Patrick J., Wallerstedt, Dawn B., Sannes, Timothy S., Stagl, Jamie, Johnson, Laura Lee, Blackman, Marc R., Grem, Jean L., Swain, Sandra M., Monahan, Brian P.

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Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension von Calvert, Melanie, Kyte, Derek, Mercieca-Bebber, Rebecca, Slade, Anita, Chan, An-Wen, King, Madeleine T, Hunn, Amanda, Bottomley, Andrew, Regnault, Antoine, Chan, An-Wen, Ells, Carolyn, O’Connor, Daniel, Revicki, Dennis, Patrick, Donald, Altman, Doug, Basch, Ethan, Velikova, Galina, Price, Gary, Draper, Heather, Blazeby, Jane, Scott, Jane, Coast, Joanna, Norquist, Josephine, Brown, Julia, Haywood, Kirstie, Johnson, Laura Lee, Campbell, Lisa, Frank, Lori, von Hildebrand, Maria, Brundage, Michael, Palmer, Michael, Kluetz, Paul, Stephens, Richard, Golub, Robert M, Mitchell, Sandra, Groves, Trish

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Erratum to “NCCAM/NCI Phase 1 Study of Mistletoe Extract and Gemcitabine in Patients with Advanced Solid Tumors” von Monahan, Brian P., Swain, Sandra M., Blackman, Marc R., Johnson, Laura Lee, Stagl, Jamie, Sannes, Timothy S., Wallerstedt, Dawn B., Mansky, Patrick J., Grem, Jean L.

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Accounting for missing data in end-of-life research von DIEHR, Paula, JOHNSON, Laura-Lee

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Overexpression of CDC25B and LAMC2 mRNA and Protein in Esophageal Squamous Cell Carcinomas and Premalignant Lesions in Subjects from a High-Risk Population in China von SHOU, Jian-Zhong, NAN HU, KONG, Li-Hui, EMMERT-BUCK, Michael R, GOLDSTEIN, Alisa M, HEWITT, Stephen M, TAYLOR, Philip R, TAKIKITA, Mikiko, ROTH, Mark J, JOHNSON, Laura Lee, GIFFEN, Carol, WANG, Quan-Hong, CHAOYU WANG, YUAN WANG, HUA SU

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Polymorphic Variation of CYP1A1 Is Associated with the Risk of Gastric Cardia Cancer: A Prospective Case-Cohort Study of Cytochrome P-450 1A1 and GST Enzymes von Roth, Mark J., Abnet, Christian C., Johnson, Laura Lee, Mark, Steven D., Dong, Zhi Wei, Taylor, Philip R., Dawsey, Sanford M., Qiao, You-Lin

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An Interview With the Food and Drug Administration About Draft Patient-Focused Drug Development Guidance 3: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Ass... von Oehrlein, Elisabeth M., Bent, Robyn, Bocell, Fraser, Garrard, Lili, Lee Johnson, Laura, Knoble, Naomi, Reasner, David, Tarver, Michelle, Weinfurt, Kevin, Mullin, Theresa

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Gene-Specific Methylation and Subsequent Risk of Colorectal Adenomas among Participants of the Polyp Prevention Trial von WOODSON, Karen, WEISENBERGER, Daniel J, CAMPAN, Mihaela, LAIRD, Peter W, TANGREA, Joseph, JOHNSON, Laura Lee, SCHATZKIN, Arthur, LANZA, Elaine

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Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials-Response von Kluetz, Paul G, Papadopoulos, Elektra J, Johnson, Laura Lee, Donoghue, Martha, Kwitkowski, Virginia E, Chen, Wen-Hung, Sridhara, Rajeshwari, Farrell, Ann T, Keegan, Patricia, Kim, Geoffrey, Pazdur, Richard

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Preface von Zhou, Xiao-Hua, Johnson, Laura Lee

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‘Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials’- Authors Response to Letter von Kluetz, Paul G., Papadopoulos, Elektra J., Johnson, Laura Lee, Donoghue, Martha, Kwitkowski, Virginia E., Chen, Wen-Hung, Sridhara, Rajeshwari, Farrell, Ann T., Keegan, Patricia, Kim, Geoffrey, Pazdur, Richard

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The statistical challenges in clinical studies. Preface von Zhou, Xiao-Hua, Johnson, Laura Lee

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Methods for incorporating death into health-related variables in longitudinal studies von Diehr, Paula, Johnson, Laura Lee, Patrick, Donald L., Psaty, Bruce

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Effects of Chronic Osteoarthritis Pain on Neuroendocrine Function in Men von Khoromi, Suzan, Muniyappa, Ranganath, Nackers, Lisa, Gray, Nora, Baldwin, Howard, Wong, Kelli Anne, Matheny, Leigh Ann, Moquin, Barbara, Rainer, Aliya, Hill, Suvimol, Remaley, Alan, Johnson, Laura Lee, Max, Mitchell B., Blackman, Marc R.

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Aryl hydrocarbon receptor expression is associated with a family history of upper gastrointestinal cancer in a high risk population exposed to aromatic hydrocarbons von Roth, Mark J., Wei, Wen-Qiang, Baer, Jessica, Abnet, Christian C., Wang, Guo-Qing, Sternberg, Lawrence R., Warner, Andrew C., Johnson, Laura Lee, Lu, Ning, Giffen, Carol A., Dawsey, Sanford M., Qiao, You-Lin, Cherry, James

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β-Catenin splice variants and downstream targets as markers for neoplastic progression of esophageal cancer von Roth, Mark J., Hu, Nan, Johnson, Laura Lee, Quon-Hang, Wang, Ahnen, Dennis J., Iwamoto, Michiko, Dawsey, Sanford M., Taylor, Philip R., Huppi, Konrad

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