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Table 3 Therapy compliance, side effects and SAEs

From: Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery: statistical analysis plan for a randomised controlled trial (UPGRADE trial)

 

UDCA (n=)

Placebo (n=)

p

Therapy compliancen (% n/N)

 Did not start trial medication

   

 Poor (< 91 pills)

   

 Moderate (< 300 pills)

   

 Good (≥ 300 pills)

   

 Complete therapy (364; all pills)

   

Side effects of treatment (AEs)n (% n/N)

 Diarrhoea

   

 Abdominal pain

   

 Skin rash

   

SAEsn (% n/N)

 Related to trial medication

   

 Not related to trial medication