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. 2024 Mar 7;13:e50513. doi: 10.2196/50513

Table 2.

Study calendar.

Screening visit, from 7 to 30 days Enrollment visit, day 0 Treatment days 1-7 Follow-up visit, day 8 (+3-day window)
Required assessments
Informed consent
Medical historya
Height and weight
Physical examination
Vital signs
ECOGb performance status
EKGc
Blood chemistriesd
Hemoglobin, absolute neutrophil count, and platelets
Urine pregnancy
Medication assessmente
Adverse event assessment
Questionnaires
Physician questionnaire
Study coordinator questionnaire
Patient questionnaire (VASf, BPIg, PROMISh, and COMPATi)
Medication diary

aMedical history and establishment of suspected or definite chronic pancreatitis diagnosis may occur at any time before trial entry.

bECOG: Eastern Cooperative Oncology Group.

cEKG: electrocardiogram.

dWill include at a minimum: electrolytes, glucose, blood urea nitrogen, creatinine and creatinine clearance, calcium, and hepatic function panel.

eWill include detailed use of rescue pain medications and opioids use.

fVAS: Visual Analog Score.

gBPI: Brief Pain Inventory.

hPROMIS: Patient-Reported Outcomes Measurement Information System.

iCOMPAT: Comprehensive Pain Assessment Tool for Chronic Pancreatitis.