Safety
inflammation/swelling, Itching
INDURATION, BLOOD, INJECTION SITE REACTION
Study visits and procedures are shown in Additional file The intensity of injection site reactions was determined by study center staff for the first four patients of each cohort, either by visual assessment or through questioning the patient, and self-reported by the rest of the patients. Injection site erythema/redness, inflammation/swelling, and induration were classified using the longest diameter of the affected skin area as mild (grade 1; 0–30 mm), moderate (grade 2; 30–120 mm), or severe (grade 3; ≥ 120 mm). Pain/tenderness was classified based on patient perception as mild (grade 1; injection site is painful when pressed), moderate (grade 2; interferes with activity) or severe (grade 3; prevents daily activity). Itching was classified as mild (grade 1; mild or localized), moderate (grade 2; intense or widespread, intermittent, limiting instrumental activities of daily living) or severe (grade 3; intense or widespread, constant, limiting self-care, instrumental activities of daily living or sleep). Blood samples were taken at each visit for clinical chemistry and hematology assessment, and were analyzed with standardized techniques.