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Among those referred 16 (14%) were lost to follow up resulting from hospital admission >30 days, migration, or ending of study.
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The primary endpoint was the change of WOMAC subscore A from inclusion to end of study.
Average family HRQL improved from baseline to end of study for all MTS dose groups.
The median time from inclusion to end of study was 4.8 years (3.9-6.0 3.9-6.0
The primary efficacy endpoint was HbA1c levels from baseline to end of study.
Changes from baseline to end of study in laboratory parameters are shown in Table 2.
The end-of-study visit was at month 12.
At the end-of-study visit, the subject's diary information was reviewed, and all end-of-study visit procedures were performed.
The study consisted of 4 visits: screening, randomization, treatment crossover, and end-of-study.
Average daily gain (ADG) was calculated from end-of-study and baseline BW.
Additional data were collected during the initial visit, subsequent visits, and end-of-study interview.
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