Table 1.

Study treatment steps 1–2

Step	Regular analgesic treatment	Study treatment	Dose
1	No analgesics (1a) or paracetamol ≤ 1 g/day (1b)	Paracetamol tablets	Maximum 3 g/day
		Placebo tablets	Inert placebo
2	Non-opioid analgesics (paracetamol > 1 g/day, and/or NSAID), or no analgesics, but with difficulty swallowing tablets (2a), or buprenorphine 5 µg/h (2b)	Buprenorphine TDS	5 µg/h (maximum 10 µg/h in 2b)
		Placebo TDS	Inert placebo

NSAID non-steroidal anti-inflammatory drug, except low-dose acetylsalicylic acid, TDS transdermal system