Table 1 SPIRIT schedule of enrolment, interventions, and assessments

Timepoint

−7 to 0 days

Day 0 (baseline)

Week 6 (±4 days)

Week 12 (±4 days)

Week 16 (±4 days)

Enrolment

 Informed consent

X

 Eligibility screen

X

X

 Medical consultation and assessment

X

X

X

X

X

 Medical history

X

 Concomitant medication

X

X

X

X

X

Intervention

 mXFP/ Placebo and Bilastine

X

X

 Outcome Assessment

 Weekly urticaria activity score (UAS7)

X

X

X

X

X

 Urticaria Control Test (UCT)

X

X

X

X

 Visual Analog Scale of Itch Severity (VAS)

X

X

X

X

 Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL)

X

X

X

X

 Angioedema Activity Score (AAS)

X

X

X

X

 Serum levels of IgE

X

X

 Gut microbiota

X

X

 AE/SAE assessment

X

X

X

Laboratory Assessment

 CBP with differentiation

X

X

 Renal and Liver function test

X

X

 Thyroid function test (FT3, FT4 and TSH)

X