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. 2016 Sep 22;2016:8294805. doi: 10.1155/2016/8294805

Table 5.

Change in mean HbA1c during dosing period (ITT and PP populations).

 5-ALA-SFC  Placebo
n Mean Change from baselinea
Mean (SE)
n Mean Change from baselinea  
Mean (SE)
Intent-to-treat population
 Week 2 32 7.6 −0.2 (0.1) 13 7.4 −0.5 (0.2)
 Week 4 30 7.5 −0.3 (0.1) 13 7.3 −0.5 (0.2)
 Week 6 28 7.3 −0.4 (0.1) 13 7.2 −0.6 (0.2)
 Week 12 25 7.1 −0.7 (0.2) 13 7.3 −0.5 (0.2)

Per protocol population
 Week 2 15 7.3 −0.3 (0.1) 6 7.6 −0.3 (0.2)
 Week 4 15 7.1 −0.4 (0.1) 7 7.3 −0.5 (0.2)
 Week 6 14 7.1 −0.4 (0.1) 7 7.2 −0.6 (0.2)
 Week 12 14 6.8 −0.8 (0.2) 7 7.3 −0.5 (0.3)

p < 0.05 compared to baseline.

aCompared to baseline mean for only the subjects with a result for the visit.