Medications of the participants at baseline.

<p>Medications of the participants at baseline.</p

Change from baseline to 3 months in primary and secondary outcomes (3-month value minus baseline value).

<p>Change from baseline to 3 months in primary and secondary outcomes (3-month value minus baseline value).</p

CONSORT diagram flow of the study.

<p>CONSORT diagram flow of the study.</p

Anti-Sh28GST antibody levels in healthy adult volunteers after administration of Alum (comparator group).

a<p>Specific Ig antibody levels are expressed as the mean of individual titer (± SEM). Number of responders after vaccination is indicated in parentheses.</p>b<p>Day of comparator administration (D₀; D₂₈; D₁₅₀).</p

Main baseline laboratory results.

<p>Abbreviations: WBC, white blood cell count; PTT, partial thromboplastin time; ALT, alanine aminotransferase; AST, aspartate aminotransferase. Data are presented as mean ± standard deviation.</p>*<p>Local laboratory values. All other biological tests were in normal ranges.</p

Specific IgG1 production and inhibition of enzymatic activity of rSh28GST by sera of vaccinated volunteers.

<p>Adult human volunteers received three administrations of rSh28GST of 100 µg respectively at D0, D28 and D150. IgG1 production is expressed as mean +/− SEM of titers at each time. Titer was defined as the highest dilution yielding an absorbance three times above background. Enzymatic inhibition is expressed in % (histograms). Percentage of inhibition was calculated by the ratio GST activity after serum incubation to GST activity control. This value was considered significantly positive above 10%.</p

Anti-Sh28GST antibody levels in healthy adult volunteers after administration of rSh28GST 100 µg.

a<p>Specific Ig antibody levels are expressed as the mean of individual titer (± SEM). Number of responders after vaccination is indicated in parentheses.</p>b<p>Day of Sh28GST administration (D₀; D₂₈; D₁₅₀).</p>*<p>Significantly different (P<0.05) compared to D₀ (comparison of mean using the Wilcoxon test).</p>**<p>Significantly different (P<0.05) compared to D₁₅₀ (comparison of mean using the Wilcoxon test).</p

Study design.

<p>Study design.</p

Course of the mean ABC-irritability score over the 3-month study duration for wet TBW (red) and dry TBW (blue).

<p>Course of the mean ABC-irritability score over the 3-month study duration for wet TBW (red) and dry TBW (blue).</p

Characteristics of study pediatricians per country.

<p>SD = standard deviation; TPE = Therapeutic Patient Education;</p><p>^a p < 10^–8,</p><p>^b p < 10^–6,</p><p>^c p<10^–4,</p><p>^d p < 10^–5</p><p>Characteristics of study pediatricians per country.</p