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Table 4 Examinations and assessments.

From: Efficacy of tibolone and raloxifene for the maintenance of skeletal muscle strength, bone mineral density, balance, body composition, cognitive function, mood/depression, anxiety and quality of life/well-being in late postmenopausal women ≥ 70 years: Study design of a randomized, double-blind, double-dummy, placebo-controlled, single-center trial

Assessment

Visit 1

Visit 2

Visit 3

Visit 4

Visit 5

Visit 6

Visit 7

 

screen

Base

mnth3

mnth6

mnth12

mnth24

mnth30

Medical history

X

      

Physical examination

X

      

Gynaecologicol examination

X

      

Breast examination

X

      

Mammography*

X

      

In/exclusion criteria

X

      

Vital signs

X

X

X

X

X

X

X

Bone mineral density

 

X

   

X

 

Body composition

 

X

X

X

X

X

X

Muscle strength

 

X

X

X

X

X

X

Cognitive function

 

X

X

X

X

X

X

Functional mobility

 

X

X

X

X

X

X

Mood/depression

 

X

X

X

X

X

X

Quality of life

 

X

X

X

X

X

X

HPA

 

X

X

X

X

X

X

Adverse events

  

X

X

X

X

 

Drug accountability

  

X

X

X

X

 
  1. * Only if not performed in the year before.