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YES NO Date of Consent: ____/____/_____ Copy of signed Informed Consent given to subject. YES NO (dd/mmm/yyyy) Height & Weight Assessment/Vital Signs (Shoes off ) Time: ____:____ (24 hour clock) Height (cm) _____ Weight (kg) _________ Temp (0C) _______ (oral (axillary Respiration Rate _______  Blood Pressure and Heart Rate (sitting and supine) SittingBlood Pressure (mmHg) ______/_______ Systolic/DiastolicHeart Rate ----------- SupineBlood Pressure (mmHg) ______/_______ Systolic/DiastolicHeart Rate ------------  Laboratory Tests* Time: ____:____ (24 hour clock) Complete Local Lab Requisition. *Serum Chemistry- ALT, AST, Creatinine, Alk Phos, Creatinine, Hemoglobin (For females of child bearing potential only) Serum B-HCG or  FORMCHECKBOX  N/A (Indicate below) >2 yrs post menopause (Year of menopause _______________) Surgically sterilized Other (Specify):______________________________________ Results of Pregnancy Test (For females of child bearing potential only): Positive * (Not Eligible to be enrolled) Negative Laboratory Tests for Central Labs Time _____:_____ (24 hour clock) Complete Central Lab Requisition. Hematology Chemistry Coagulation Trough serum digoxin – for pt on digoxin only Urinalysis  List labs not done/reason:  *Any abnormal laboratory results must be assessed by the Investigator for possible clinical significance. Any clinically significant laboratory abnormalities and their subsequent follow up are to be documented in the source documents. Clinically significant laboratory abnormalities must be included on the Adverse Events CRF page. 12 – Lead ECG (Investigator to review for clinical abnormalities and sign/date). Completed ECG. Print out 2 ECG reports and have Investigator review and sign both copies. Were all screening procedures completed ? YES NO If no explain: __________________________________________________________________________________ _____________________________________________________________________________________________ PI / Physician’s Checklist Review/ Sign Informed Consent and answer any questions with Patient Review and sign off Medical History Review Screening Inclusion/ Exclusion Criteria for enrollment considerations to date Complete physical exam Review and sign off ECG Review methods of birth control for females of child bearing potential Review and sign Pregnancy/Lab results Comments: ___________________________________________________________________________________________ __________________________________________________________________________________________ ___________________________________________________________________________________________ ___________________________________________________________________________________________ Physician/ Investigator Physical Exam SYSTEMNORMALABNORMAL If yes: CS NCSCOMMENTS (Comment if Abnormal: Clinically Significant or Not Clinically Significant)SKIN FORMCHECKBOX  FORMCHECKBOX  FORMCHECKBOX   FORMCHECKBOX HENT FORMCHECKBOX  FORMCHECKBOX  FORMCHECKBOX   FORMCHECKBOX EYES FORMCHECKBOX  FORMCHECKBOX  FORMCHECKBOX   FORMCHECKBOX HEART FORMCHECKBOX  FORMCHECKBOX  FORMCHECKBOX   FORMCHECKBOX CHEST/LUNGS FORMCHECKBOX  FORMCHECKBOX  FORMCHECKBOX   FORMCHECKBOX ABDOMEN FORMCHECKBOX  FORMCHECKBOX  FORMCHECKBOX   FORMCHECKBOX REFLEXES FORMCHECKBOX  FORMCHECKBOX  FORMCHECKBOX   FORMCHECKBOX LYMPH NODES FORMCHECKBOX  FORMCHECKBOX  FORMCHECKBOX   FORMCHECKBOX SPINE FORMCHECKBOX  FORMCHECKBOX  FORMCHECKBOX   FORMCHECKBOX NERVOUS SYSTEM FORMCHECKBOX  FORMCHECKBOX  FORMCHECKBOX   FORMCHECKBOX EXTREMITIES FORMCHECKBOX  FORMCHECKBOX  FORMCHECKBOX   FORMCHECKBOX OTHER (specify) ________________ FORMCHECKBOX  FORMCHECKBOX  FORMCHECKBOX   FORMCHECKBOX OTHER (specify) ________________ FORMCHECKBOX  FORMCHECKBOX  FORMCHECKBOX   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