A: Follow-Up Schedule etc 1 2 3 4, or or or or Visit Visit Visit Visit Completion Point Point Point Procedures Discontinuation Baseline Screening Time Study Time Study Time Study Time Study Study Premature Signed Consent Form X X Assessment of Eligibility X X Criteria Review of Medical History X X Review of Concomitant X X X X X X X X Medications Study Intervention X Complete X X X X (X) (X) (X) (X) Vital Signs (X) (X) (X) (X) (X) Examination Physical Assessment of Adverse Events (X) (X) (X) (X) X X Chemistry X X (X) (X) (X) (X) X X Hematology X X (X) (X) (X) (X) X X Urinalysis X X (X) (X) (X) (X) X X Clinical Laboratory Immunology __mL whole blood X (X) (X) X X Research Laboratory (X) (X) (X) (X) (X) Other Procedures
A: Follow-Up Schedule Procedures Screening Baseline Time Point or Study Visit 1 Time Point or Study Visit 2 Time or Study Visit 3 Time Point or Study Visit 4, etc Study Completion Premature Discontinuation Signed Consent Form X X Assessment of Eligibility Criteria X X Review of Medical History X X Review of Concomitant Medications X X X X X X X X Study Intervention X Physical Examination Complete X X X X (X) (X) (X) (X) Vital Signs (X) (X) (X) (X) (X) Assessment of Adverse Events (X) (X) (X) (X) X X Clinical Laboratory Chemistry X X (X) (X) (X) (X) X X Hematology X X (X) (X) (X) (X) X X Urinalysis X X (X) (X) (X) (X) X X Research Laboratory Immunology __mL whole blood X (X) (X) X X Other Procedures (X) (X) (X) (X) (X)