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. 2015 Jul 7;16:294. doi: 10.1186/s13063-015-0806-y

Table 1.

Schedule of the trial

Items Screening/run-in period Visit 1 (baseline) Visit 2 Visit 3 Visit 4 (endpoint) Visit 5 (follow-up)
Week of the trial −2/−1 0 4 8 12 16
Demographic information-taking +
Informed consent form (PICF) +
General medical history-taking +
Severity of AE for inclusion and exclusion of the participants (NESS) +
Blood tests + + +
Clinical sign of AE (EASI) + + + + +
Symptoms (POEM) + + + + +
QoL score (CDLQI) + + + + +
Distributions of treatment or placebo products + + +
Daily medical record + + + + + +
Monitor of adverse event + + + + +
Compliance check + + + + +
Survey of participation +

Abbreviations: AE atopic eczema, CDLQI Children’s Dermatology Life Quality Index, EASI Eczema Area and Severity Index, NESS Nottingham Eczema Severity Score, PICF participant information and consent form, POEM Patient-Oriented Eczema Measure, QoL quality of life