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Table 2 Treatment schedule and outcome measures

From: A first-in-human clinical study of laparoscopic autologous myoblast sheet transplantation to prevent delayed perforation after duodenal endoscopic mucosal dissection

=A2:I15

Screening

Days

-49

0

1

3

7

At discharge

49

Informed concent

〇

       

Baseline characterization

〇

       

Eligibility check

〇

       

Vital signs*

〇

〇

〇

〇

〇

〇

〇

〇

Blood tests†

〇

〇

〇

〇

〇

〇

〇

〇

AbdominalCT

〇

   

〇

 

〇

 

Endoscopy

〇

  

〇

 

〇

〇

〇

Drain examination‡

   

〇

〇

   

Muscle collection

 

〇

      

Transplantation

  

〇

     

Primary endopoint

    

〇

   

Adverse events

 

→

→

→

→

→

→

→

  1. *Blood pressure, Pulse rate, Body temperature
  2. †WBC, RBC, Hg, Ht, PLT, AST, ALT, T-Bil, D-Bil, Amy, LDH, ALP, BUN, Cre, TG, Alb, CK, Na, K, Cl, CRP, Glu
  3. ‡Amy, T-Bil
  4. CT: computed tomography