This trial is an open, national, multi-centre trial. The trial will be initiated in December 2013 and subjects will receive treatment for 6 weeks. Safety monitoring will be performed in an ongoing basis through a Clinical Safety Group with immediate access to Adverse Events registered in the clinical database. The composition, procedures and deliverables of the Clinical Safety Group will be detailed in a Safety Agreement prior to trial start.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
51
AVANZ Salsola
Hospital General Universitario de Alicante
Alicante, Alicante, Spain
Frequency of patients with adverse reactions
Time frame: Participants will be followed for an expected average of 6 weeks
Frequency of patients with systemic reactions according to EAACI classification
Time frame: Participants will be followed for an expected average of 6 weeks
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