Table 1

Project flow and follow-up items.

ProjectBefore treatment/baselinePeriod of treatment/intervention and follow-up (14 days)After the treatment/call-back
0 week (−5 to −1 days)1 week/day 72 weeks/day 14Within 4–8 weeks
Screening×  
Informed consent×  
Inclusion and exclusion criteria×  
Medical history collection×  
Vital signs××××
Randomisation×  
Blood routine test× ×
Urine routine test× ×
Renal function test× ×
liver function test× ×
ECG× ×
14C UBT× ×
Stool H. pylori antigen× ×
Specimens× ×
Treatment and follow-up×××
Concomitant medications××××
AEs×××
Surplus medicines recycling ×

  • The ‘×’ is the item or operation content that must be performed in the project.

  • 14C UBT, 14C-urea breath test; AEs, adverse events.