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The incidence of TEAEs was 77% in the BTDS 20 group, 59% in the BTDS 5 group, and 73% in the oxycodone group.
Four separate sensitivity analyses showed that BTDS 20 and oxycodone were significantly more effective for pain control than BTDS 5.
The study had two arms: the BTDS group which received the study drug, buprenorphine transdermal patch (NORSPAN[R]), and the TA group which received the comparator drug, tramadol 37.5 mg/acetaminophen 325 mg tablet (Ultracet[R] ER Semi Tab), which is commonly used in Korea (Figure 1).
Noninferiority of BTDS to TA for pain reduction at week 6 was evaluated.
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- BTE-binding protein 1
- BTE-binding protein 2
- BTE-binding protein 3
- BTE-binding protein 4
- BTE-binding protein 5