Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Objective Response (Complete response, Partial response, Stable disease, Progressive disease). Measurement time: 2, 4 and 6 months.
Key secondary outcomes:
Immunoglobulin's levels-IgA, IgG, IgM (Normal, Enlarged, Diminished). Measurement time: at baseline, 4 and 6 months.
Clinical State (Satisfactory, Acceptable, Equal). Measurement time: at baseline, 4 and 6 months.
Oxidative-damage scoreboards (Normal, Enlarged, Diminished). Measurement time: at baseline and, 6 months.
Antirust- defense scoreboards: at baseline and, 6 months.
Adverse Events-AE (Occurrence of AE (Yes, No), Description of AE (name of the adverse event), Intensity of AE (Light, Moderated, Severe)). Measurement time: 2, 4 and 6 months.
Illnesses associated (Occurrence of illnesses associated (Yes, No), Description of illness (Allergic, Autoimmune, Infectious)). Measurement time: at baseline.