| Outcome Measures: |
Primary: Mixed-Meal Tolerance Test (MMTT)-Stimulated 2-hour C-peptide Area Under the Curve (AUC), Week 52 | Secondary: MMTT-Stimulated Peak and 4-hour C-peptide AUC, Weeks 52 and 104|MMTT-Stimulated 2-hour C-Peptide AUC Assessed Over Time, Weeks 0, 14, 26, 52, and 104|Insulin Use in Units Per Kilogram Body Weight Per Day, Weeks 52 and 104|Hypoglycemic Events Occurring from Randomization to End of Trial, Throughout the Study|Glycosylated Hemoglobin (HbA1c) Levels, Weeks 52 and 104|Emergence of Anti-Alpha 1-Antitrypsin (AAT) Antibodies, Throughout the Study|Frequency and Severity of All Adverse Events (AEs), Throughout the study|Changes in D-dimer Levels Indicating Alteration in Coagulant/Anticoagulant Balance, Throughout the study|Pharmacokinetic Parameters of Aralast NP, Throughout the study
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| Locations: |
University of California San Diego, La Jolla, California, 92093, United States|Barbara Davis Center, Aurora, Colorado, 80045, United States|Yale University, New Haven, Connecticut, 06511, United States|Atlanta Diabetes Associates, Atlanta, Georgia, 30309, United States|Emory University, Atlanta, Georgia, 30322, United States|University of Iowa, Iowa City, Iowa, 52242, United States|University of Maryland Medical Center, Baltimore, Maryland, 21201, United States|Calvert Memorial Hospital, Prince Frederick, Maryland, 20678, United States|Massachusetts General Hospital, Boston, Massachusetts, 02114, United States|Joslin Diabetes Center, Boston, Massachusetts, 02215, United States|University of Massachusetts Medical School, Worchester, Massachusetts, 01655, United States|Columbia University, New York, New York, 10027, United States|Nationwide Children's Hospital, Columbus, Ohio, 43205, United States|The Children's Hospital of Philadelphia, Philadephia, Pennsylvania, 19104, United States|Cetero Research San Antonio, San Antonio, Texas, 78229, United States
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