In the experimental model of meningitis, clinical parameters such as clinical score and weight difference were assessed at defined time points.
The primary endpoint of the study was the callus formation, radiologically assessed at defined days, and histologically assessed at day 30.
Sporozoites was assessed before cryopreservation, for release of the lot, and to assess stability at defined time points after cryopreservation.
Median annual NO2 and PM10 concentrations were 33.0 μg/m and 30.5 μg/m, respectively, as assessed at coordinates defined using the building-matching technique.
Histological remission was assessed at Day 57, defined as a Geboes Index score of <2.0 (standard) 23 or <1.0 (stringent), 20 24 25 and is reported with 95% CIs.
The primary end point was the rate of objective response assessed at 24 weeks, defined as the proportion of patients with confirmed CR, clinical complete response (CCR) or PR, as determined by the Objective Primary Disease Response Evaluation Criteria OPDRECC).
Complete fistula healing/closure (assessed at every visit) was defined as no drainage, either spontaneous or with gentle compression.
The MED was assessed at 24 h, and defined as the lowest dose of UVB that resulted in detectable erythema.
The presence or absence of clinically probable AD was assessed at 24 months and defined as: 1) MMSE <26; 2) Clinical Dementia Rating (CDR) ≥0.5; and 3) positive NINCDS/ADRDA criteria for probable AD [ 24].
Systemic response was also assessed at W28 and was defined as a decrease of ≥3 points in ESSDAI score [ 15] in accordance with its minimal clinically important improvement [ 16].
