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Table 7 Adverse events reported during the course of the open-label extension*

From: Safety of phosphatidylserine containing omega-3 fatty acids in non-demented elderly: a double-blind placebo-controlled trial followed by an open-label extension

PS-DHA continuers

PS-DHA naive**

Adverse event

Number of related or probably related adverse events

Number of not-related or probably not related adverse events

Number of not-related or probably not related adverse events

Gastrointestinal discomfort

1

 

3

Hypertension

 

1

3

Hypotension

 

1

 

Fall

 

1

 

Tenesmus

1

  

Amaurosis fugax

 

1

 

Mild bleeding due to Hemorrhoids

 

1

 

Platelets decrease

 

1

 

Hand Fracture

 

1

 

Hyperlipidemia

  

1

Dizziness

 

1

 

Urinal tract infection

  

1

Arm pigmentation

  

1

Headache

1

1

 

SUM

3 events in 3 participants

9 events in 7 participants

9 events in 6 participants

  1. * Judged by the study physicians as related, probably related, not related or probably not related to the study treatment
  2. ** There were no adverse events classified by the study physicians as related or probably related to the study treatment