Alternative therapy | Standard therapy | P-value* | Absolute difference in change | Two-sided 95% CI | |
---|---|---|---|---|---|
Primary Objective: | n = 202 | n = 221 | |||
Change in PC, days 1 to 7†, mean activity units (%) ± SD | 31 ± 29 | 24 ± 29 | 0.011 | 7 | (2, 13) |
Classification of change‡, n (%) | |||||
No change or decreased | 38 (18.8) | 61 (27.6) | |||
Increased, but still deficient | 64 (31.7) | 60 (27.1) | |||
Increased and above LLN | 100 (49.5) | 100 (45.2) | |||
Secondary Objective Moderate deficiency group: | n = 171 | n = 175 | |||
Change in PC, days 1 to 7†, mean activity units (%) ± SD, | 30 ± 29 | 24 ± 28 | 0.047 | 6 | (0, 12) |
Classification of change‡, n (%) | |||||
No change or decreased | 35 (20.5) | 46 (26.3) | |||
Increased, but still deficient | 50 (29.2) | 44 (25.1) | |||
Increased and above LLN | 86 (50.3) | 85 (48.6) | |||
Secondary Objective Severe deficiency group: | n = 31 | n = 46 | |||
Change in PC, days 1 to 7†, mean activity units (%) ± SD, | 38 ± 27 | 25 ± 32 | 0.063 | 13 | (-1, 27) |
Classification of change‡, n (%) | |||||
No change or decreased | 3 (9.7) | 15 (32.6) | |||
Increased, but still deficient | 14 (45.2) | 16 (34.8) | |||
Increased and above LLN | 14 (45.2) | 15 (32.6) |