| Outcome Measures: |
Primary: Occurrence of AEs (including Injection site reactions) and SAEs, From screening to 12 months.|Number of Clinically Significant Abnormal Results from Physical examinations, including neurological and Vital Signs assessments, From screening to 12 months.|Number of Clinically Significant Abnormal Results From Laboratory measurements, including hematology, clinical chemistry, metabolic status parameters (fasting C-peptide, HbA1c, fasting glucose) and urine analysis, From screening to 12 months. | Secondary: Stage progression, Number of individuals progressing from stage 1 to stage 2 and from stage 2 to stage 3., From screening to 12 months.|T1D diagnosis, Time to T1D diagnosis., From screening to 12 months.|Time to stage progression, Time from stage 1 to stage 2 and time from stage 2 to stage 3., From screening to 12 months.|OGTT stimulated C-peptide, Change in C-peptide /insulin /glucose (Area Under the Curve \[AUC\]mean 0-120 min) during a 2-hour Oral Glucose Tolerance Test (OGTT) from screening to 12 months., From screening to 12 months.|Change in Hemoglobin A1c (HbA1c), Change in Hemoglobin A1c (HbA1c) from baseline to 12 months., From baseline to 12 months.|Change in time in glycemic target range, Change in time in glycemic target range 3.9 to 10 mmol/L (70 to 180 mg/dL) and 3.9 to 7.8 mmol/L (70 to 140 mg/dL) evaluated from continuous glucose monitoring (CGM) data from screening to 12 months., From screening to 12 months.|Change in time in range > 13.9 mmol/L, Change in time in range \> 13.9 mmol/L (\> 250 mg/dL) evaluated from CGM data from screening to 12 months., From screening to 12 months.|Change in time in range > 10 mmol/L, Change in time in range \> 10 mmol/L (\> 180 mg/dL) evaluated from CGM data from screening to 12 months., From screening to 12 months.|Change in time in range > 7.8 mmol/L, Change in time in range \> 7.8 mmol/L (\> 140 mg/dL) evaluated from CGM data from screening to 12 months., From screening to 12 months.|Change in glycemic variation, Change in glycemic variation (Coefficient of variation \[CV\], SD) evaluated from CGM data from screening to 12 months., From screening to 12 months.|Variables that indicate effects on the immune system, Variables that indicate effects on the immune system such as the concentration of serum autoantibodies., From baseline to 12 months.
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