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Table 1 Schedule of Study Events

From: Phase II study of metformin for reduction of obesity-associated breast cancer risk: a randomized controlled trial protocol

Study Events Consenting/Screening Baseline/Randomization Intervention (12 month (52 ± 4 weeks))
Months 1–3 Month 3 Visit (13 ± 2 weeks) Months 4–6 Month 6 Visit (26 ± 4 weeks) Months 7–9 Month 9 Visit (39 ± 2 weeks) Months 10 –12 Month 12 Visit (52 ± 4 weeks) Follow up
Consent, med records release form x           
Medical history, performance status x           
Anthropometric measurements x x     x     x  
Vital signs (Temp, BP, Pulse) x x   x   x   x   x  
Concomitant meds x x   x   x   x   x  
Breast cancer risk questionnaire x           
Menstrual pattern/cycle review x x   x   x   x   x  
Menstrual cycle diary x x x x x x x x x x  
Fasting blood (CBC/Diff, CMP, lipids, FSHa, estradiola) x          x  
Fasting blood for research endpoints   x     x     x  
Urine pregnancy test x x   x   x   x   x  
Urine for research endpoints   x     x     x  
AFFQ, AAFQb   x         x  
Nipple aspirate fluid (NAF) collection   x     x     x  
Breast MRIc   x     x     x  
Core biopsy, if consented   x     x      
Final eligibility assessment   x          
Randomization   x          
Dispense study agent   x     x      
Intake calendar    x x x x x x x x  
Adverse events diary   x x x x x x x x x x
Adverse events review   x   x   x   x   x x
Return study agent       x     x  
Compliance assessment     x   x   x   x  
Case report form completion x x   x   x   x   x x
Telephone/email contactd    x   x   x   x   
  1. aFSH (follicle-stimulating hormone) and/or estradiol at screening for women with uncertain menopausal status
  2. bAFFQ: Arizona Food Frequency Questionnaire; AAFQ: Arizona Activity Frequency Questionnaire
  3. cWomen who cannot fit into the MRI scanner due to the large body size will continue the study and undergo all other study procedures
  4. dStudy personnel will contact subjects within a week after study agent has been initiated and within a week following scheduled dose increase to assess compliance and any potential problems. Additional periodic telephone or email contact will occur between study visits and as needed to review study procedures, adverse events, concomitant medications, and to address any subject concerns