Total Symptom Score (TSS) statistics and the change of the total score by the end of the treatment period, in total study population and in subgroups defined by HbA1c (below 8.0% vs ≥8.0%) and baseline TSS (below 7.5 vs ≥7.5)
| Experimental group (SINR) n=108 | Placebo group n=107 | P value | |
| ITT, TSS (±SD) | − | − | |
| Day 1 | 6.96 (±1.02) | 6.89 (±1.17) | 0.619 |
| Day 86 | 4.31 (±1.65) | 5.06 (±1.56) | 0.0012 |
| Change | −2.65 (±1.46) | −1.73 (±1.51) | <0.0001 |
| PP, TSS (±SD) | 101 | ||
| Day 1 | 6.98 (±1.04) | 6.80 (±1.12) | 0.242 |
| Day 86 | 4.33 (±1.67) | 5.09 (±1.54) | 0.0011 |
| Change | −2.65 (±1.49) | −1.71 (±1.47) | <0.0001 |
| TSS in patients with baseline HbA1c, <8.0% | 55 | 45 | |
| Day 1 | 6.86 (±0.88) | 6.64 (±1.07) | 0.243 |
| Day 86 | 4.21 (±1.35) | 4.99 (±1.69) | 0.0119 |
| Change | −2.65 (±1.04) | −1.65 (±1.41) | 0.0001 |
| TSS in patients with baseline HbA1c, ≥8.0% (n) | 50 | 55 | |
| Day 1 | 7.08 (±1.16) | 7.08 (±1.21) | 0.991 |
| Day 86 | 4.43 (±1.94) | 5.11 (±1.47) | 0.0438 |
| Change | −2.65 (±1.83) | −1.80 (±1.59) | 0.0120 |
| TSS in patients with baseline TSS <7.5 (n) | 77 | 78 | |
| Day 1 | 6.48 (±0.58) | 6.33 (±0.61) | 0.131 |
| Day 86 | 3.85 (±1.28) | 4.72 (±1.32) | 0.0001 |
| Change | −2.63 (±1.24) | −1.60 (±1.31) | <0.0001 |
| TSS in patients with baseline TSS ≥7.5 (n) | 28 | 22 | |
| Day 1 | 8.29 (±0.76) | 8.53 (±0.83) | 0.253 |
| Day 86 | 5.58 (±1.91) | 6.24 (±1.82) | 0.223 |
| Change | −2.72 (±1.96) | −2.21 (±2.03) | 0.372 |
HbA1c, hemoglobin A1c; ITT, full analysis set; PP, per protocol; SINR, succinic acid+inosine+nicotinamide+riboflavin.