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Table 1 Follow-up procedures and main outcome measures

From: Breast ductal lavage for biomarker assessment in high risk women: rationale, design and methodology of a randomized phase II clinical trial with nimesulide, simvastatin and placebo

  

Month

Tests and Procedures

0

3

6

9

12

24

Informed consent

X

     

Eligibility checklist

X

     

Medical history

X

     

Mammography

X

   

X

X

Breast Ultrasound (if indicated)

X

   

X

X

Physical examination

X

X

X

X

X

X

Ductal Lavage (or FNA)

X

   

X

X

Concomitant medication

X

X

X

X

X

X

AE/ADR (*)

X

X

X

X

X

X

Hematology/biochemistry

X

X

X

X

X

X

Hormones, IGFs, SHBG, C-Reactive Protein

X

   

X

X

  1. (*) AE/ADR, adverse event/adverse drug reaction.
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BMC Cancer

ISSN: 1471-2407

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