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Table 2 Inclusion and exclusion criteria

From: Efficacy and safety of Ban-Lan-Gen granules in the treatment of seasonal influenza: study protocol for a randomized controlled trial

Inclusion criteria Exclusion criteria
(1) With confirmed infection by the influenza A (H1N1, H3N2) or influenza B virus according to real-time polymerase chain reaction (PCR) or viral culture (1) Age <18 years or >65 years
(2) Confirmed bronchitis, pneumonia, pleural effusion and interstitial lung disease via chest imaging (radiograph or CT)
(2) Aged 18 to 65 years; axillary temperature ≥38°C and at least two constitutional symptoms (headache, chill, myalgia or fatigue) and one respiratory symptom (cough, sore throat, or rhinitis) (3) Routine screening tests of blood with leukocyte readings >10.0 × 109/L or neutrophil count ≥80%
(4) Suppurative tonsillitis or purulent sputum
(3) Illness onset within 36 h (5) Underling primary disorders such as hematological disease, chronic obstructive pulmonary disease (FEV1/FVC <70%, FEV1/predicated value <50%; or respiratory failure or right-heart failure), hepatic disease (ALT or AST ≥ triple ULN), renal disease (serum creatinine > 2 mg/dL) or chronic congestive heart failure (NYHA III to IV)
(4) Granting of written informed consent
  (6) Previous administration of antiviral drugs (amantadine, rimantadine, zanamivir, or oseltamivir phosphate) before disease onset and study enrollment, or administration of traditional Chinese herbal medicine or proprietary Chinese medicine. Administration of BLG granules within 1 week before disease onset
  (7) Allergy to study medication(s)
  (8) Women who are pregnant, or may possibly become pregnant, or who are lactating with a positive urine pregnant test, or with a body mass index (BMI) ≥25 kg/m2
  (9) The immunodeficient: malignant tumor; organ or bone-marrow transplantation; AIDS; or taken immune inhibitors during the last 3 months
  (10) Suspicion or history of alcohol/drug abuse
  (11) Participation in another clinical trial <3 months before study randomization
  (12) Acute respiratory infection, otitis, or nasosinusitis 2 weeks before study enrollment
  (13) Vaccination with the influenza vaccine within 6 months
  (14) Other reasons at the investigator’s discretion