Schedule of Evaluations Baseline, Screening: Follow-up: Enrollment, Treatment Treatment Treatment Treatment Treatment Assessment Visit-1 (Day-14 Final Visit Randomization: Visit 2 (W1) Visit 3 (W2) Visit 4 (W3) Visit 5 (W4) Visit 6 (W5) to Day -1) (W10) Visit 1 (Day 0) Informed Consent Form X Demographics X X DXA X X Medical History X General Physical X X X X X Examination Current Medications X X Blood Chemistries X X X X X Hematology X X X X X Urine Analysis X X X X X Vital Signs X X X X X X X X Inclusion/Exclusion Criteria X Enrollment/Randomization X Treatment Administration X X X X X Form Concomitant Medications X X X X X X X Adverse Events X X X X X X X
Schedule of Evaluations Assessment Screening: Visit-1 (Day-14 to Day -1) Baseline, Enrollment, Randomization: Visit 1 (Day 0) Treatment Visit 2 (W1) Treatment Visit 3 (W2) Treatment Visit 4 (W3) Treatment Visit 5 (W4) Treatment Visit 6 (W5) Follow-up: Final Visit (W10) Informed Consent Form X Demographics X X DXA X X Medical History X General Physical Examination X X X X X Current Medications X X Blood Chemistries X X X X X Hematology X X X X X Urine Analysis X X X X X Vital Signs X X X X X X X X Inclusion/Exclusion Criteria X Enrollment/Randomization X Treatment Administration Form X X X X X Concomitant Medications X X X X X X X Adverse Events X X X X X X X
startup_protocol_template.docx