An Open-Label Randomized Trial Is Conducted to Compare a New

An open-label randomized trial is conducted to compare a new nonsteroidal anti-inflammatory agent (AG) and low-dose colchicine for the treatment of gout flares in primary care.  A total of 400 adults with gout flares were randomized 1:1 to AG for 7 days or low-dose colchicine three times per day for 4 days.  The primary outcome was change in pain intensity from baseline measured over the first 7 days.  At Day 7 follow-up, about 25% of participants in the low-dose colchicine group had switched treatment to AG, and about 15% of participants in the low-dose colchicine group had stopped treatment altogether.  The primary investigator decided to preserve the original randomization for the data analysis.  Which of the following describes the data analysis approach adopted by the primary investigator?

A) Correlation analysis
B) Intention-to-treat analysis
C) Per-protocol analysis
D) Regression analysis
E) Stratified analysis

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