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. 2014 Apr 12;383(9925):1297–1304. doi: 10.1016/S0140-6736(13)62301-6

Table 1.

Clinical endpoints for first and second phases

Control (n=46) Active (n=39) p value
First phase
Number desensitised 0 24 <0·001*
Number not desensitised 46 15
Proportion desensitised 0 (0 to 0·091) 0·62 (0·45 to 0·78) ..
Proportion able to tolerate daily ingestion 0 0·84 (0·70 to 0·93) ..
Median absolute change in NOAEL, mg 0 (−95 to 45) 1345 (45 to 1400) 0·002, <0·001
Median fold change in NOAEL, mg 0·81 (0·05 to 1·82) 25·5 (1·82 to 280) 0·003, <0·001
Median NOAEL after first phase, mg 5 (5 to 400) 1400 (100 to 1400) <0·001§
Second phase
Proportion desensitised 0·54 (0·35 to 0·72) .. ..
Proportion able to tolerate daily ingestion 0·91 (0·79 to 0·98) .. ..
Median change in FAQLQ-PF score from baseline to post-treatment −1·41 (−4·83 to 1·38) −1·61 (−4·87 to 0·24) <0·001, <0·001**

Data are proportion (95% CI) or median (range). NOAEL=no observed adverse effect level. FAQLQ-PF=Food Allergy Quality of Life Questionnaire—Parent Form for 5–12 years.

*

From Fisher's exact test.

From Wilcoxon signed rank tests.

Median difference in NOAEL between groups was 1395 mg (95% CI 395 to 1395); p<0·001 (from Mann Whitney U test).

§

From Mann Whitney U test.

n=20.

n=19.

**

From Wilcoxon signed rank tests.