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1
Department of Pathology, Brigham and Women’s Hospital and Harvard Medical School, Thorn 530, 75 Francis St., Boston, MA 02115.
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Department of Pathology, University of Virginia Medical School, PO Box 800214, Charlottesville, VA 22908.
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Department of Child Health, University of Missouri School of Medicine, 1 Hospital Dr., Columbia, MO 65212.
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Weill Medical College of Cornell University, 1300 York Ave., Suite LC-623, New York, NY 10021.
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Department of Pathology, University of Alabama at Birmingham, 701 S. 19th St., Birmingham, AL 35294.
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Veterans Administration Medical Center, Birmingham, AL 35233.
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American Diabetes Association, 1701 Beauregard St., Alexandria, VA 22311.
aAuthor for correspondence. Fax 617-278-6921; e-mail dsacks{at}rics.bwh.harvard.edu.
Background: Multiple laboratory tests are used in the diagnosis and management of patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially.
Approach: An expert committee drafted evidence-based recommendations for the use of laboratory analysis in patients with diabetes. An external panel of experts reviewed a draft of the guidelines, which were modified in response to the reviewers’ suggestions. A revised draft was posted on the Internet and was presented at the AACC Annual Meeting in July, 2000. The recommendations were modified again in response to oral and written comments. The guidelines were reviewed by the Professional Practice Committee of the American Diabetes Association.
Content: Measurement of plasma glucose remains the sole diagnostic criterion for diabetes. Monitoring of glycemic control is performed by the patients, who measure their own plasma or blood glucose with meters, and by laboratory analysis of glycated hemoglobin. The potential roles of noninvasive glucose monitoring, genetic testing, autoantibodies, microalbumin, proinsulin, C-peptide, and other analytes are addressed.
Summary: The guidelines provide specific recommendations based on published data or derived from expert consensus. Several analytes are of minimal clinical value at the present time, and measurement of them is not recommended.
The following articles in journals at HighWire Press have cited this article:
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  H.-Y. Li, C.-H. Hua, Y.-R. Lin, M.-S. Lin, and J.-N. Wei Effect of Fluoride-Containing Tubes on Accuracy of Glucometers Diabetes Care, May 1, 2008; 31(5): e33 - e33. [Full Text] [PDF]
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 J. L. Camargo, G. M. Lara, A. E. Wendland, J. L. Gross, and M. J. de Azevedo Agreement of Different Immunoassays for Urinary Albumin Measurement Clin. Chem., May 1, 2008; 54(5): 925 - 927. [Full Text] [PDF]
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J. L. Kitzmiller, J. M. Block, F. M. Brown, P. M. Catalano, D. L. Conway, D. R. Coustan, E. P. Gunderson, W. H. Herman, L. D. Hoffman, M. Inturrisi, et al. Managing Preexisting Diabetes for Pregnancy: Summary of evidence and consensus recommendations for care Diabetes Care, May 1, 2008; 31(5): 1060 - 1079. [Full Text] [PDF]
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 A. Smaldone Glycemic Control and Hemoglobinopathy: When A1C May Not Be Reliable Diabetes Spectr, January 1, 2008; 21(1): 46 - 49. [Full Text] [PDF]
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American Diabetes Association Standards of Medical Care in Diabetes--2008 Diabetes Care, January 1, 2008; 31(Supplement_1): S12 - S54. [Full Text] [PDF]
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 R. S. Parekh, W.H. L. Kao, L. A. Meoni, E. Ipp, P. L. Kimmel, J. La Page, C. Fondran, W. C. Knowler, M. J. Klag, and and the Family Investigation of Nephropathy and Di Reliability of Urinary Albumin, Total Protein, and Creatinine Assays after Prolonged Storage: The Family Investigation of Nephropathy and Diabetes Clin. J. Am. Soc. Nephrol., November 1, 2007; 2(6): 1156 - 1162. [Abstract] [Full Text] [PDF]
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 T. J. Amiss, D. B. Sherman, C. M. Nycz, S. A. Andaluz, and J. B. Pitner Engineering and rapid selection of a low-affinity glucose/galactose-binding protein for a glucose biosensor Protein Sci., November 1, 2007; 16(11): 2350 - 2359. [Abstract] [Full Text] [PDF]
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 N Travier, M Jeffreys, N Brewer, C. Wright, C. Cunningham, J Hornell, and N Pearce Association between glycosylated hemoglobin and cancer risk: a New Zealand linkage study Ann. Onc., August 1, 2007; 18(8): 1414 - 1419. [Abstract] [Full Text] [PDF]
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 E. Selvin, C. M. Crainiceanu, F. L. Brancati, and J. Coresh Short-term Variability in Measures of Glycemia and Implications for the Classification of Diabetes Arch Intern Med, July 23, 2007; 167(14): 1545 - 1551. [Abstract] [Full Text] [PDF]
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 W S Waring, L E Evans, and C T Kirkpatrick Glycolysis inhibitors negatively bias blood glucose measurements: potential impact on the reported prevalence of diabetes mellitus J. Clin. Pathol., July 1, 2007; 60(7): 820 - 923. [Abstract] [Full Text] [PDF]
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 R. J. Schrot, K. T. Patel, and P. Foulis Evaluation of Inaccuracies in the Measurement of Glycemia in the Laboratory, by Glucose Meters, and Through Measurement of Hemoglobin A1c Clin. Diabetes, April 1, 2007; 25(2): 43 - 49. [Abstract] [Full Text] [PDF]
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K. Dungan, J. Chapman, S. S. Braithwaite, and J. Buse Glucose Measurement: Confounding Issues in Setting Targets for Inpatient Management Diabetes Care, February 1, 2007; 30(2): 403 - 409. [Full Text] [PDF]
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American Diabetes Association Standards of Medical Care in Diabetes--2007 Diabetes Care, January 1, 2007; 30(suppl_1): S4 - S41. [Full Text] [PDF]
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 M. Rodriguez-Yanez, M. Castellanos, M. Blanco, M. Millan, F. Nombela, T. Sobrino, I. Lizasoain, R. Leira, J. Serena, A. Davalos, et al. Micro- and macroalbuminuria predict hemorrhagic transformation in acute ischemic stroke. Neurology, October 10, 2006; 67(7): 1172 - 1177. [Abstract] [Full Text] [PDF]
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W S A Smellie, J Forth, D Bareford, P Twomey, M J Galloway, E C M Logan, S R S Smart, T M Reynolds, and C Waine Best practice in primary care pathology: review 3. J. Clin. Pathol., August 1, 2006; 59(8): 781 - 789. [Abstract] [Full Text] [PDF]
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 A. D. Mooradian, M. Bernbaum, and S. G. Albert Narrative Review: A Rational Approach to Starting Insulin Therapy Ann Intern Med, July 18, 2006; 145(2): 125 - 134. [Abstract] [Full Text] [PDF]
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G. B.B. Kristensen, K. Nerhus, G. Thue, and S. Sandberg Results and Feasibility of an External Quality Assessment Scheme for Self-Monitoring of Blood Glucose Clin. Chem., July 1, 2006; 52(7): 1311 - 1317. [Abstract] [Full Text] [PDF]
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 F. Corica, A. Corsonello, R. Ientile, D. Cucinotta, A. Di Benedetto, F. Perticone, L. J. Dominguez, and M. Barbagallo Serum Ionized Magnesium Levels in Relation to Metabolic Syndrome in Type 2 Diabetic Patients J. Am. Coll. Nutr., June 1, 2006; 25(3): 210 - 215. [Abstract] [Full Text] [PDF]
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A. Mosca, R. Paleari, M. G. Dalfra, G. Di Cianni, I. Cuccuru, G. Pellegrini, L. Malloggi, M. Bonomo, S. Granata, F. Ceriotti, et al. Reference Intervals for Hemoglobin A1c in Pregnant Women: Data from an Italian Multicenter Study Clin. Chem., June 1, 2006; 52(6): 1138 - 1143. [Abstract] [Full Text] [PDF]
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D. Rodriguez Cabaleiro, D. Stockl, J. M. Kaufman, T. Fiers, and L. M. Thienpont Feasibility of Standardization of Serum C-Peptide Immunoassays with Isotope-Dilution Liquid Chromatography-Tandem Mass Spectrometry Clin. Chem., June 1, 2006; 52(6): 1193 - 1196. [Abstract] [Full Text] [PDF]
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J. E. Shaw, P. Z. Zimmet, and K. G. M.M. Alberti Point: Impaired Fasting Glucose: The Case for the New American Diabetes Association Criterion Diabetes Care, May 1, 2006; 29(5): 1170 - 1172. [Full Text] [PDF]
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 C. D. Saudek, R. L. Derr, and R. R. Kalyani Assessing Glycemia in Diabetes Using Self-monitoring Blood Glucose and Hemoglobin A1c JAMA, April 12, 2006; 295(14): 1688 - 1697. [Abstract] [Full Text] [PDF]
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 R. Gambino, S. Reichberg, J. G. Schwartz, A. Tirosh, I. Shai, and A. Rudich Normal Fasting Plasma Glucose Levels and Type 2 Diabetes N. Engl. J. Med., January 5, 2006; 354(1): 87 - 88. [Full Text] [PDF]
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American Diabetes Association Standards of Medical Care in Diabetes-2006 Diabetes Care, January 1, 2006; 29(suppl_1): S4 - S42. [Full Text] [PDF]
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 J. Incerti, T. Zelmanovitz, J. L. Camargo, J. L. Gross, and M. J. de Azevedo Evaluation of tests for microalbuminuria screening in patients with diabetes Nephrol. Dial. Transplant., November 1, 2005; 20(11): 2402 - 2407. [Abstract] [Full Text] [PDF]
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M. W. Steffes and D. B. Sacks Measurement of Circulating Glucose Concentrations: The Time Is Now for Consistency among Methods and Types of Samples Clin. Chem., September 1, 2005; 51(9): 1569 - 1570. [Full Text] [PDF]
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P. D'Orazio, R. W. Burnett, N. Fogh-Andersen, E. Jacobs, K. Kuwa, W. R. Kulpmann, L. Larsson, A. Lewenstam, A. H.J. Maas, G. Mager, et al. Approved IFCC Recommendation on Reporting Results for Blood Glucose (Abbreviated) Clin. Chem., September 1, 2005; 51(9): 1573 - 1576. [Abstract] [Full Text] [PDF]
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M. P. Francescato, L. Cattin, M. Geat, E. Tosoratti, S. Lazzer, C. Noacco, and P. E. di Prampero Glucose Pulse: A simple method to estimate the amount of glucose oxidized during exercise in type 1 diabetic patients Diabetes Care, August 1, 2005; 28(8): 2028 - 2030. [Full Text] [PDF]
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S. Skeie, C. Perich, C. Ricos, A. Araczki, A. R. Horvath, W. P. Oosterhuis, T. Bubner, G. Nordin, R. Delport, G. Thue, et al. Postanalytical External Quality Assessment of Blood Glucose and Hemoglobin A1c: An International Survey Clin. Chem., July 1, 2005; 51(7): 1145 - 1153. [Abstract] [Full Text] [PDF]
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A. J. Bakker, A. Bierma-Ram, H. Keidel, H. Syperda, and A. Zijlstra (Micro)Albuminuria: Antigen Excess Detection in the Roche Modular Analyzer Clin. Chem., June 1, 2005; 51(6): 1070 - 1071. [Full Text] [PDF]
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H. W. Vesper, E. Archibold, K. H. Porter, and G. L. Myers Assessment of a Reference Procedure to Collect and Analyze Glucose in Capillary Whole Blood Clin. Chem., May 1, 2005; 51(5): 901 - 903. [Full Text] [PDF]
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D. B. Sacks and for the ADA/EASD/IDF Working Group of the HbA1c As Global Harmonization of Hemoglobin A1c Clin. Chem., April 1, 2005; 51(4): 681 - 683. [Full Text] [PDF]
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W. L. Roberts, S. Safar-Pour, B. K. De, C. L. Rohlfing, C. W. Weykamp, and R. R. Little Effects of Hemoglobin C and S Traits on Glycohemoglobin Measurements by Eleven Methods Clin. Chem., April 1, 2005; 51(4): 776 - 778. [Full Text] [PDF]
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J. L. Gross, M. J. de Azevedo, S. P. Silveiro, L. H. Canani, M. L. Caramori, and T. Zelmanovitz Diabetic Nephropathy: Diagnosis, Prevention, and Treatment Diabetes Care, January 1, 2005; 28(1): 164 - 176. [Abstract] [Full Text] [PDF]
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American Diabetes Association Standards of Medical Care in Diabetes Diabetes Care, January 1, 2005; 28(suppl_1): S4 - S36. [Full Text] [PDF]
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R. Rej Clinical Chemistry through Clinical Chemistry: A Journal Timeline Clin. Chem., December 1, 2004; 50(12): 2415 - 2458. [Abstract] [Full Text] [PDF]
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W. Jones, J. Scott, S. Leary, F. Stratton, S. Smith, R. Jones, A. Day, A. Ness, and ALSPAC Study Team Stability of Whole Blood at -70 {degrees}C for Measurement of Hemoglobin A1c in Healthy Individuals Clin. Chem., December 1, 2004; 50(12): 2460 - 2461. [Full Text] [PDF]
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E. Selvin, S. Marinopoulos, G. Berkenblit, T. Rami, F. L. Brancati, N. R. Powe, and S. H. Golden Meta-Analysis: Glycosylated Hemoglobin and Cardiovascular Disease in Diabetes Mellitus Ann Intern Med, September 21, 2004; 141(6): 421 - 431. [Abstract] [Full Text] [PDF]
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R. R. Miles, R. F. Roberts, A. R. Putnam, and W. L. Roberts Comparison of Serum and Heparinized Plasma Samples for Measurement of Chemistry Analytes Clin. Chem., September 1, 2004; 50(9): 1704 - 1706. [Full Text] [PDF]
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 W.-D. Li, C. Dong, D. Li, C. Garrigan, and R. A. Price A Quantitative Trait Locus Influencing Fasting Plasma Glucose in Chromosome Region 18q22-23 Diabetes, September 1, 2004; 53(9): 2487 - 2491. [Abstract] [Full Text] [PDF]
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H. J. Woerle, W. P. Pimenta, C. Meyer, N. R. Gosmanov, E. Szoke, T. Szombathy, A. Mitrakou, and J. E. Gerich Diagnostic and Therapeutic Implications of Relationships Between Fasting, 2-Hour Postchallenge Plasma Glucose and Hemoglobin A1c Values Arch Intern Med, August 9, 2004; 164(15): 1627 - 1632. [Abstract] [Full Text] [PDF]
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H. A. Tran, D. Silva, and N. Petrovsky Case Study: Potential Pitfalls of Using Hemoglobin A1c as the Sole Measure of Glycemic Control Clin. Diabetes, July 1, 2004; 22(3): 141 - 143. [Full Text]
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A. Ponce-de-Leon, Ma. d. L. Garcia-Garcia, Ma. C. Garcia-Sancho, F. J. Gomez-Perez, J. L. Valdespino-Gomez, G. Olaiz-Fernandez, R. Rojas, L. Ferreyra-Reyes, B. Cano-Arellano, M. Bobadilla, et al. Tuberculosis and Diabetes in Southern Mexico Diabetes Care, July 1, 2004; 27(7): 1584 - 1590. [Abstract] [Full Text] [PDF]
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P J Twomey Plasma glucose measurement with the Yellow Springs Glucose 2300 STAT and the Olympus AU640 J. Clin. Pathol., July 1, 2004; 57(7): 752 - 754. [Abstract] [Full Text] [PDF]
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Expert Committee on the Diagnosis and Classificati Follow-up Report on the Diagnosis of Diabetes Mellitus Clin. Diabetes, April 1, 2004; 22(2): 71 - 79. [Full Text] [PDF]
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Follow-up Report on the Diagnosis of Diabetes Mellitus Diabetes Spectr, January 1, 2004; 17(1): 51 - 59. [Full Text] [PDF]
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The Expert Committee on the Diagnosis and Classifi Follow-up Report on the Diagnosis of Diabetes Mellitus Diabetes Care, November 1, 2003; 26(11): 3160 - 3167. [Full Text] [PDF]
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W. D. Comper, G. Jerums, and T. M. Osicka Deficiency in the Detection of Microalbuminuria by Urinary Dipstick in Diabetic Patients Diabetes Care, November 1, 2003; 26(11): 3195 - 3196. [Full Text] [PDF]
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 S. G. Gabbe and C. R. Graves Management of Diabetes Mellitus Complicating Pregnancy Obstet. Gynecol., October 1, 2003; 102(4): 857 - 868. [Abstract] [Full Text] [PDF]
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M. A.J. van Dijk, J. B. Reitsma, J. C. Fischer, and G. T.B. Sanders Indications for Requesting Laboratory Tests for Concurrent Diseases in Patients with Carpal Tunnel Syndrome: A Systematic Review Clin. Chem., September 1, 2003; 49(9): 1437 - 1444. [Abstract] [Full Text] [PDF]
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 T. A. Baird, M. W. Parsons, T. Phanh, K. S. Butcher, P. M. Desmond, B. M. Tress, P. G. Colman, B. R. Chambers, and S. M. Davis Persistent Poststroke Hyperglycemia Is Independently Associated With Infarct Expansion and Worse Clinical Outcome Stroke, September 1, 2003; 34(9): 2208 - 2214. [Abstract] [Full Text] [PDF]
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D. B. Sacks Hemoglobin Variants and Hemoglobin A1c Analysis: Problem Solved? Clin. Chem., August 1, 2003; 49(8): 1245 - 1247. [Full Text] [PDF]
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Q.-P. Qin, O. Peltola, and K. Pettersson Time-resolved Fluorescence Resonance Energy Transfer Assay for Point-of-Care Testing of Urinary Albumin Clin. Chem., July 1, 2003; 49(7): 1105 - 1113. [Abstract] [Full Text] [PDF]
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T. Nakanishi, K. Iguchi, and A. Shimizu Method for Hemoglobin A1c Measurement Based on Peptide Analysis by Electrospray Ionization Mass Spectrometry with Deuterium-labeled Synthetic Peptides as Internal Standards Clin. Chem., May 1, 2003; 49(5): 829 - 831. [Full Text] [PDF]
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J. Penders, T. Fiers, and J. R. Delanghe Quantitative Evaluation of Urinalysis Test Strips Clin. Chem., December 1, 2002; 48(12): 2236 - 2241. [Abstract] [Full Text] [PDF]
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R. Star, T. Hostetter, and G. L. Hortin New Markers for Kidney Disease Clin. Chem., September 1, 2002; 48(9): 1375 - 1376. [Full Text] [PDF]
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L. D. Youngman, S. Clark, S. Manley, R. Peto, and R. Collins Reliable Measurement of Glycated Hemoglobin in Frozen Blood Samples: Implications for Epidemiologic Studies Clin. Chem., September 1, 2002; 48(9): 1627 - 1629. [Full Text] [PDF]
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