 - An unsatisfactory response inadequate efficacy or poor tolerability that includes all 3 classes of analgesic medications acetaminophenparacetamol, NSAIDs, and opioids and receiving an opioid at study entry; For participants in the USA and Canada: An unsatisfactory response inadequate efficacy or poor tolerability that includes all 3 classes of analgesic medications acetaminophenparacetamol, NSAIDs, and opioids other than codeine or codeine combination products and receiving an opioid other than codeine or codeine combination products at study entry 