Scott R Evans

Scott R Evans

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Scott R Evans

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Group-sequential logrank methods for trial designs using bivariate non-competing event-time outcomes.

Lifetime Data Anal 2020 Apr 12;26(2):266-291. Epub 2019 Apr 12.

Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, 27705, USA.

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http://dx.doi.org/10.1007/s10985-019-09470-4DOI Listing
April 2020

Analytical evaluation of the Abbott RealTime CT/NG Assay for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in rectal and pharyngeal swabs.

J Mol Diagn 2020 Apr 2. Epub 2020 Apr 2.

Division of Infectious Diseases, David Geffen School of Medicine at UCLA, Los Angeles, California; Fielding School of Public Health, University of California, Los Angeles, California. Electronic address:

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http://dx.doi.org/10.1016/j.jmoldx.2020.03.004DOI Listing
April 2020

Applying a Risk-benefit Analysis to Outcomes in Tuberculosis Clinical Trials.

Clin Infect Dis 2020 Feb;70(4):698-703

Harvard T. H. Chan School of Public Health, Boston, Massachusetts.

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http://dx.doi.org/10.1093/cid/ciz784DOI Listing
February 2020

Modern clinician-initiated clinical trials to determine optimal therapy for multi-drug resistant Gram-negative infections.

Clin Infect Dis 2019 Nov 18. Epub 2019 Nov 18.

Centre for Clinical Research, Faculty of Medicine, The University of Queensland, Royal Brisbane and Women's Hospital Campus, Brisbane, Australia.

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http://dx.doi.org/10.1093/cid/ciz1132DOI Listing
November 2019

Presenting Risks and Benefits: Helping the Data Monitoring Committee Do Its Job.

Ann Intern Med 2019 Nov 19. Epub 2019 Nov 19.

Duke University Medical Center, Durham, North Carolina (F.R.).

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http://dx.doi.org/10.7326/M19-1491DOI Listing
November 2019

Reply to Humphrey and Spafford.

Clin Infect Dis 2019 Oct;69(10):1831-1832

The Biostatistics Center and the Department of Epidemiology and Biostatistics, George Washington University, Rockville, Maryland.

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http://dx.doi.org/10.1093/cid/ciz228DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6821162PMC
October 2019

Design, data monitoring, and analysis of clinical trials with co-primary endpoints: A review.

J Biopharm Stat 2018 30;28(1):28-51. Epub 2017 Oct 30.

a Department of Data Science , National Cerebral and Cardiovascular Center , Osaka , Japan.

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http://dx.doi.org/10.1080/10543406.2017.1378668DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6135538PMC
July 2019

Average Weighted Accuracy (AWA): Pragmatic Analysis for a RADICAL Study.

Clin Infect Dis 2019 Jun 3. Epub 2019 Jun 3.

Biostatistics Center, George Washington Milken Institute School of Public Health.

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http://dx.doi.org/10.1093/cid/ciz437DOI Listing
June 2019

Studying new antibiotics for multidrug resistant infections: are today's patients paying for unproved future benefits?

BMJ 2018 02 22;360:k587. Epub 2018 Feb 22.

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA.

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http://dx.doi.org/10.1136/bmj.k587DOI Listing
February 2018

Group-sequential three-arm noninferiority clinical trial designs.

J Biopharm Stat 2017 18;27(1):1-24. Epub 2016 Feb 18.

b Department of Mathematical Health Science , Osaka University Graduate School of Medicine, Suita , Japan.

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http://dx.doi.org/10.1080/10543406.2016.1148710DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4990829PMC
January 2018

Risk for Major Bleeding in Patients Receiving Ticagrelor Compared With Aspirin After Transient Ischemic Attack or Acute Ischemic Stroke in the SOCRATES Study (Acute Stroke or Transient Ischemic Attack Treated With Aspirin or Ticagrelor and Patient Outcomes).

Circulation 2017 Sep 27;136(10):907-916. Epub 2017 Jun 27.

From Department of Neurology, University of California, San Francisco (J.D.E.); AstraZeneca, Gothenburg, Sweden (M.A., S.B.-S., H.D., P.H., M.J., J.J.); Stanford University Medical Center, Stanford Stroke Center, Palo Alto, CA (G.W.A.); Department of Neurology and Stroke Center, Bichat University Hospital and Medical School, Paris, France (P.A.); Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA (S.R.E.); National Cerebral and Cardiovascular Center, Suita, Osaka, Japan (K.M.); Stroke Unit, Hospital Vall d'Hebron, Barcelona, Spain (C.A.M.); Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (Y.W.); Department of Medicine and Therapeutics, Chinese University of Hong Kong, China (K.S.L.W.); and Dean's Office, Dell Medical School, University of Texas, Austin (S.C.J.).

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http://dx.doi.org/10.1161/CIRCULATIONAHA.117.028566DOI Listing
September 2017

Ticagrelor Versus Aspirin in Acute Embolic Stroke of Undetermined Source.

Stroke 2017 09 18;48(9):2480-2487. Epub 2017 Jul 18.

From the Department of Neurology and Stroke Center, Bichat University Hospital and Paris-Diderot, Sorbonne University, Paris, France (P.A.); Stanford University Medical Center, Stanford Stroke Center, Palo Alto, CA (G.W.A.); AstraZeneca, Gothenburg, Sweden (H.D., P.H., J.J., P.L.); Department of Neurology, University of California San Francisco (J.D.E.); Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, MA (S.R.E.); Department of Clinical Neurosciences, Hotchkiss Brain Institute, University of Calgary, Canada (M.D.H.); Department of Neurology, Perelman School of Medicine, University of Pennsylvania Health System, Philadelphia (S.E.K.); National Cerebral and Cardiovascular Center, Suita, Osaka, Japan (K.M.); Stroke Unit, Hospital Vall d'Hebron, Barcelona, Spain (C.A.M.); Department of Neurology, Tiantan Hospital, Beijing, China (Y.W.); Department of Medicine & Therapeutics, Chinese University of Hong Kong, SAR (K.S.L.W.); and Dell Medical School, University of Texas, Austin (S.C.J.).

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https://www.ahajournals.org/doi/10.1161/STROKEAHA.117.017217
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http://dx.doi.org/10.1161/STROKEAHA.117.017217DOI Listing
September 2017

Interim evaluation of efficacy or futility in group-sequential trials with multiple co-primary endpoints.

Biom J 2017 Jul 19;59(4):703-731. Epub 2016 Oct 19.

Center for Biostatistics in AIDS Research, Department of Biostatistics, Harvard T. H. Chan School of Public Heath, Boston, MA, 02115, USA.

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http://dx.doi.org/10.1002/bimj.201600026DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6222168PMC
July 2017

Methods and issues in studies of CRE.

Virulence 2017 05 28;8(4):453-459. Epub 2016 Jul 28.

b Epidemiology and Public Health , University of Maryland , MD , USA.

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http://dx.doi.org/10.1080/21505594.2016.1213473DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5477696PMC
May 2017

Sizing clinical trials when comparing bivariate time-to-event outcomes.

Stat Med 2017 04 24;36(9):1363-1382. Epub 2017 Jan 24.

Department of Information and Computer Technology, Faculty of Engineering, Tokyo University of Science, Tokyo, Japan.

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http://dx.doi.org/10.1002/sim.7225DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5533151PMC
April 2017

The Antibacterial Resistance Leadership Group: Progress Report and Work in Progress.

Clin Infect Dis 2017 Mar;64(suppl_1):S3-S7

Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.

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http://dx.doi.org/10.1093/cid/ciw824DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5850447PMC
March 2017

Advancing Diagnostics to Address Antibacterial Resistance: The Diagnostics and Devices Committee of the Antibacterial Resistance Leadership Group.

Clin Infect Dis 2017 Mar;64(suppl_1):S41-S47

Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Division of Infectious Diseases, Department of Medicine, Mayo Clinic, Rochester, Minnesota.

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http://dx.doi.org/10.1093/cid/ciw831DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5848376PMC
March 2017

Evaluating Anti-Infective Drugs in the Resistant Pathogen Setting: Can we Use External Controls?

Stat Commun Infect Dis 2017 14;9(1). Epub 2017 Mar 14.

Leidos Biomedical Research in support of the Division of Clinical Research, National Institutes of Health, Bethesda, Maryland, USA.

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http://dx.doi.org/10.1515/scid-2016-0003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5529043PMC
March 2017

Ticagrelor in Acute Stroke or Transient Ischemic Attack in Asian Patients: From the SOCRATES Trial (Acute Stroke or Transient Ischemic Attack Treated With Aspirin or Ticagrelor and Patient Outcomes).

Stroke 2017 01 29;48(1):167-173. Epub 2016 Nov 29.

From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (Y.W.); China National Clinical Research Center for Neurological Diseases, Beijing (Y.W.); Center of Stroke, Beijing Institute for Brain Disorders, China (Y.W.); Beijing Key Laboratory of Translational Medicine for Cerebrovascular Disease, China (Y.W.); National Cerebral and Cardiovascular Center, Suita, Osaka, Japan (K.M.); Department of Medicine and Therapeutics, Chinese University of Hong Kong (K.S.L.W.); Department of Neurology and Stroke Center, Bichat University Hospital and Medical School, Paris, France (P.A.); Department of Neurology, Stanford University Medical Center, Stanford Stroke Center, Palo Alto, CA (G.W.A.); AstraZeneca, Gothenburg, Sweden (H.D., P.H., J.J.); Department of Neurology, University of California, San Francisco (D.E.); Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA (S.R.E.); Stroke Unit, Hospital Vall d'Hebron, Barcelona, Spain (C.A.M.); and Dean's Office, Dell Medical School, University of Texas, Austin (S.C.J.).

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http://dx.doi.org/10.1161/STROKEAHA.116.014891DOI Listing
January 2017

Using Outcomes to Analyze Patients Rather than Patients to Analyze Outcomes: A Step toward Pragmatism in Benefit:risk Evaluation.

Stat Biopharm Res 2016 6;8(4):386-393. Epub 2016 Dec 6.

National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH).

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https://www.tandfonline.com/doi/full/10.1080/19466315.2016.1
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http://dx.doi.org/10.1080/19466315.2016.1207561DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5394932PMC
December 2016

Benefit-risk Evaluation for Diagnostics: A Framework (BED-FRAME).

Clin Infect Dis 2016 09 18;63(6):812-7. Epub 2016 May 18.

Louis Stokes Cleveland Veterans Affairs Medical Center, Case Western Reserve University School of Medicine, Ohio.

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http://dx.doi.org/10.1093/cid/ciw329DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4996133PMC
September 2016

Totality of outcomes: A different paradigm in assessing interventions for treatment of tuberculosis.

J Clin Tuberc Other Mycobact Dis 2016 Aug;4:9-13

Center for Biostatistics in AIDS Research and Department of Biostatistics, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA.

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http://dx.doi.org/10.1016/j.jctube.2016.05.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5193477PMC
August 2016

Ticagrelor versus Aspirin in Acute Stroke or Transient Ischemic Attack.

N Engl J Med 2016 Jul 10;375(1):35-43. Epub 2016 May 10.

From the Dean's Office, Dell Medical School, University of Texas, Austin (S.C.J.); the Department of Neurology and Stroke Center, Bichat University Hospital and Medical School, Paris (P.A.); Stanford University Medical Center, Stanford Stroke Center, Palo Alto (G.W.A.), and the Department of Neurology, University of California, San Francisco, San Francisco (J.D.E.) - both in California; AstraZeneca, Gothenburg, Sweden (H.D., P.H., J.J.); the Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston (S.R.E.); the National Cerebral and Cardiovascular Center, Suita, Osaka, Japan (K.M.); the Stroke Unit, Hospital Vall d'Hebron, Barcelona (C.A.M.); the Department of Neurology, Tiantan Hospital, Beijing (Y.W.); and the Department of Medicine and Therapeutics, Chinese University of Hong Kong, Hong Kong (K.S.L.W.).

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http://www.nejm.org/doi/10.1056/NEJMoa1603060
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http://dx.doi.org/10.1056/NEJMoa1603060DOI Listing
July 2016

Corrigendum: A logrank test-based method for sizing clinical trials with two co-primary time-to-event endpoints (10.1093/biostatistics/kxs057).

Biostatistics 2016 07;17(3):603-4

Department of Biostatistics, Harvard University School of Public Heath, Boston, MA 02115-6018, USA.

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http://dx.doi.org/10.1093/biostatistics/kxw021DOI Listing
July 2016

Rapid Molecular Diagnostics, Antibiotic Treatment Decisions, and Developing Approaches to Inform Empiric Therapy: PRIMERS I and II.

Clin Infect Dis 2016 Jan 25;62(2):181-9. Epub 2015 Sep 25.

Department of Medicine, Case Western Reserve University School of Medicine Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, Ohio Departments of Pharmacology, Molecular Biology and Microbiology, Biochemistry, and Proteomics and Bioinformatics, Case Western Reserve University School of Medicine, Cleveland, Ohio.

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http://dx.doi.org/10.1093/cid/civ837DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4690483PMC
January 2016

Comment: Fundamentals and Innovation in Antibiotic Trials.

Stat Biopharm Res 2015;7(4):331-336. Epub 2015 Dec 17.

National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH).

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http://dx.doi.org/10.1080/19466315.2015.1094406DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4831648PMC
December 2015

Patterns of peripheral neuropathy in ART-naïve patients initiating modern ART regimen.

J Neurovirol 2015 Apr 13;21(2):210-8. Epub 2015 Feb 13.

Center for Biostatistics in AIDS Research, Department of Biostatistics, FXB 604B, Harvard School of Public Health, 651 Huntington Avenue, Boston, MA, 02115, USA,

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http://dx.doi.org/10.1007/s13365-015-0327-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4624403PMC
April 2015

Group-Sequential Strategies in Clinical Trials with Multiple Co-Primary Outcomes.

Stat Biopharm Res 2015;7(1):36-54

Department of Biostatistics, Kyoto University School of Public Health, Japan.

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http://dx.doi.org/10.1080/19466315.2014.1003090DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4382106PMC
January 2015

Difficulties in demonstrating superiority of an antibiotic for multidrug-resistant bacteria in nonrandomized studies.

Clin Infect Dis 2014 Oct 30;59(8):1142-7. Epub 2014 Jun 30.

Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore VA Maryland Health Care System, Baltimore.

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http://dx.doi.org/10.1093/cid/ciu486DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4271096PMC
October 2014

Sample size determination in group-sequential clinical trials with two co-primary endpoints.

Stat Med 2014 Jul 27;33(17):2897-913. Epub 2014 Mar 27.

Department of Biomedical Statistics, Osaka University Graduate School of Medicine, Osaka, Japan; Office of Biostatistics and Data Management, Research and Development Initiative Center, National Cerebral and Cardiovascular Center, Osaka, Japan.

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http://dx.doi.org/10.1002/sim.6154DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4082481PMC
July 2014

Peripheral neuropathy in ART-experienced patients: prevalence and risk factors.

J Neurovirol 2013 Dec 3;19(6):557-64. Epub 2013 Dec 3.

Harvard School of Public Health, 651 Huntington Avenue, FXB-607, Boston, MA, 02115, USA,

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http://dx.doi.org/10.1007/s13365-013-0216-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3965352PMC
December 2013

A logrank test-based method for sizing clinical trials with two co-primary time-to-event endpoints.

Biostatistics 2013 Jul 10;14(3):409-21. Epub 2013 Jan 10.

Department of Mathematical Sciences, Hirosaki University Graduate School of Science and Technology, 3 Bunkyocho, Hirosaki, Aomori 036-8561, Japan.

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http://dx.doi.org/10.1093/biostatistics/kxs057DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4148615PMC
July 2013

HIV peripheral neuropathy progression: protection with glucose-lowering drugs?

J Neurovirol 2012 Oct 18;18(5):428-33. Epub 2012 Jul 18.

Center for Biostatistics in AIDS Research, Department of Biostatistics, FXB-513 Harvard School of Public Health, Boston, MA 02115, USA.

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http://dx.doi.org/10.1007/s13365-012-0119-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3485691PMC
October 2012

Treatment with pravastatin and fenofibrate improves atherogenic lipid profiles but not inflammatory markers in ACTG 5087.

J Clin Lipidol 2010 Jul-Aug;4(4):279-87

Division of Infectious Diseases, Department of Internal Medicine, University of Cincinnati College of Medicine, PO Box 670405, 231 Albert Sabin Way, Cincinnati, OH 45267-0405, USA.

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http://dx.doi.org/10.1016/j.jacl.2010.04.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2932453PMC
June 2011

Vicriviroc and peripheral neuropathy: results from AIDS Clinical Trials Group 5211.

HIV Clin Trials 2010 Jan-Feb;11(1):51-8

Harvard School of Public Health, Boston, Massachusetts 02115, USA.

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http://dx.doi.org/10.1310/hct1101-51DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2958041PMC
May 2010

Clinical trial structures.

Authors:
Scott R Evans

J Exp Stroke Transl Med 2010 Feb;3(1):8-18

Department of Statistics, Harvard University, Boston, MA.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3059315PMC
http://dx.doi.org/10.6030/1939-067x-3.1.8DOI Listing
February 2010

Common statistical concerns in clinical trials.

Authors:
Scott R Evans

J Exp Stroke Transl Med 2010 Feb;3(1):1-7

Department of Statistics, Harvard University, Boston, MA.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3059317PMC
http://dx.doi.org/10.6030/1939-067x-3.1.1DOI Listing
February 2010

Fundamentals of clinical trial design.

Authors:
Scott R Evans

J Exp Stroke Transl Med 2010 Jan;3(1):19-27

Department of Statistics, Harvard University, Boston, MA.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3083073PMC
http://dx.doi.org/10.6030/1939-067x-3.1.19DOI Listing
January 2010

Predicted Interval Plots (PIPS): A Graphical Tool for Data Monitoring of Clinical Trials.

Stat Biopharm Res 2009 Nov;1(4):348-355

Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, Boston, MA.

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http://dx.doi.org/10.1198/sbr.2009.0041DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3059316PMC
November 2009

Clinical validation of the NeuroScreen.

J Neurovirol 2005 Dec;11(6):503-11

Department of Neurosciences, UCSD AntiViral Research Center and HIV Neurobehavioral Research Center, University of California, San Diego, California 92103, USA.

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http://dx.doi.org/10.1080/13550280500384966DOI Listing
December 2005

The neuropsychological and neurological impact of hepatitis C virus co-infection in HIV-infected subjects.

AIDS 2005 Oct;19 Suppl 3:S64-71

Washington University School of Medicine, St Louis, MO 63110, USA.

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http://dx.doi.org/10.1097/01.aids.0000192072.80572.43DOI Listing
October 2005

Phase II evaluation of low-dose oral etoposide for the treatment of relapsed or progressive AIDS-related Kaposi's sarcoma: an AIDS Clinical Trials Group clinical study.

J Clin Oncol 2002 Aug;20(15):3236-41

Center for Biostatistics in AIDS Research, Department of Biostatistics, Harvard School of Public Health, Boston, MA, USA.

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http://dx.doi.org/10.1200/JCO.2002.12.038DOI Listing
August 2002