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Table 1 Design of study

From: Protocol for assessing the hypotensive effect of evening administration of acetylsalicylic acid: study protocol for a randomized, cross-over controlled trial

Schedule of events (Day counted from the first visit, Day 0)

Screening: visit 1 (Day −15)

Baseline, enrolment, randomization: visit 2(Day 0)

Treatment: visit 3 day 30

Treatment visit 4 day 60

Treatment visit 5 day 90

Washout 1 month

Treatment visit 6 day 150

Treatment visit 7 day 180

Treatment visit 8 day 210

Study procedures

         

Informed consent form

X

        

Medical history

X

        

Physical examination including weight and height measurements

 

X

       

Demographic data

X

        

Intervention

         

Control/Intervention group I (ASA in the morning and placebo in the evening in the first period)

  

X

X

X

Crossover

X

X

X

Intervention/Control group II (placebo in the morning and ASA in the evening in the first period)

  

X

X

X

X

X

X

Blood chemistry

         

Haematology and biochemistry

 

X

      

X

Efficacy measures

         

ABPM

 

X

  

X

   

X

Safety assessment

  

X

X

X

 

X

X

X

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Trials

ISSN: 1745-6215