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Table 1

Clinical characteristics of the intention-to-treat population at baseline

ALAPlaceboP
n 230 224  
Age (years) 53.3 ± 8.3 53.9 ± 7.6 0.3607 
Sex (% male) 66.1 67.0 0.8430 
BMI (kg/m229.7 ± 6.1 29.8 ± 6.1 0.9226 
Heart rate (bpm) 76.3 ± 12.3 74.6 ± 12.6 0.1603 
Type 1/type 2 diabetes 27.4 / 72.6 21.0 / 79.0 0.1111 
Diabetes duration (years) 13.3 (0.8–56.1) 13.5 (0.9–46.7) 0.4190 
Neuropathy duration (years) 3.0 (0.0–25.4) 3.2 (0.0–21.1) 0.2588 
Insulin treatment 58.9 55.1 0.4170 
HbA1c 8.9 ± 1.8 8.8 ± 1.9 0.6354 
Fasting blood glucose (mmol/L) 11.1 ± 4.68 10.9 ± 4.26 0.6529 
Nephropathy 11.7 12.0 0.5935 
Retinopathy 45.5 43.6 0.6833 
Neuropathy stage 1/stage 2a 11.3 / 88.7 9.8 / 90.2 0.6074 
NIS-LL+7 (nds) 17.1 ± 8.4 16.8 ± 8.0 0.6740 
NIS (points) 12.7 ± 8.6 12.2 ± 7.8 0.5062 
NIS-LL (points) 9.8 ± 5.6 9.5 ± 5.3 0.6087 
Peroneal MNCV (m/s) 38.5 ± 5.03 38.1 ± 6.48 0.4957 
Sural SNAP (µV) 2.49 ± 3.38 2.43 ± 3.21 0.8387 
Vibration perception threshold (JND) 21.27 ± 3.18 21.21 ± 3.52 0.8393 
Cold detection threshold (JND) 17.86 ± 5.14 17.58 ± 5.33 0.5765 
Heart rate deep breathing (bpm) 7.26 ± 5.44 8.59 ± 6.59 0.0193 
NSC weakness (number) 0.06 ± 0.30 0.03 ± 0.23 0.2353 
NSC weakness (severity) 0.10 ± 0.56 0.04 ± 0.31 0.1613 
TSS (points) 2.4 ± 1.9 2.6 ± 1.8 0.2752 
ALAPlaceboP
n 230 224  
Age (years) 53.3 ± 8.3 53.9 ± 7.6 0.3607 
Sex (% male) 66.1 67.0 0.8430 
BMI (kg/m229.7 ± 6.1 29.8 ± 6.1 0.9226 
Heart rate (bpm) 76.3 ± 12.3 74.6 ± 12.6 0.1603 
Type 1/type 2 diabetes 27.4 / 72.6 21.0 / 79.0 0.1111 
Diabetes duration (years) 13.3 (0.8–56.1) 13.5 (0.9–46.7) 0.4190 
Neuropathy duration (years) 3.0 (0.0–25.4) 3.2 (0.0–21.1) 0.2588 
Insulin treatment 58.9 55.1 0.4170 
HbA1c 8.9 ± 1.8 8.8 ± 1.9 0.6354 
Fasting blood glucose (mmol/L) 11.1 ± 4.68 10.9 ± 4.26 0.6529 
Nephropathy 11.7 12.0 0.5935 
Retinopathy 45.5 43.6 0.6833 
Neuropathy stage 1/stage 2a 11.3 / 88.7 9.8 / 90.2 0.6074 
NIS-LL+7 (nds) 17.1 ± 8.4 16.8 ± 8.0 0.6740 
NIS (points) 12.7 ± 8.6 12.2 ± 7.8 0.5062 
NIS-LL (points) 9.8 ± 5.6 9.5 ± 5.3 0.6087 
Peroneal MNCV (m/s) 38.5 ± 5.03 38.1 ± 6.48 0.4957 
Sural SNAP (µV) 2.49 ± 3.38 2.43 ± 3.21 0.8387 
Vibration perception threshold (JND) 21.27 ± 3.18 21.21 ± 3.52 0.8393 
Cold detection threshold (JND) 17.86 ± 5.14 17.58 ± 5.33 0.5765 
Heart rate deep breathing (bpm) 7.26 ± 5.44 8.59 ± 6.59 0.0193 
NSC weakness (number) 0.06 ± 0.30 0.03 ± 0.23 0.2353 
NSC weakness (severity) 0.10 ± 0.56 0.04 ± 0.31 0.1613 
TSS (points) 2.4 ± 1.9 2.6 ± 1.8 0.2752 

Data are means ± SD, median (range), or %. P values derived from χ2 test for binary data and from t tests otherwise. JND, just noticeable difference; SNAP, sensory nerve action potential.

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