Table 3 Protocol deviations

Became apparent post-randomisation that participant did not fulfil eligibility criteria

n/N (%)

n/N (%)

 Took opioid medicines for this episode

n/N (%)

n/N (%)

 Pain duration > 12 weeks

n/N (%)

n/N (%)

 Had bony metastasis

n/N (%)

n/N (%)

Did not receive treatment as allocated

n/N (%)

n/N (%)

 Took concomitant opioid medication during the treatment period

n/N (%)

n/N (%)

 Never collected medication kit

n/N (%)

n/N (%)

 Was dispensed medicine from an incorrect kit

n/N (%)

n/N (%)

Discrepency in data collection procedure

n/N (%)

n/N (%)

 Verbal consent received prior to enrolment, written consent followed

n/N (%)

n/N (%)

 Unable to obtain baseline data

n/N (%)

n/N (%)

 Obtained Brief Pain Inventory from a proxy

n/N (%)

n/N (%)

 Baseline questionnaire completed > 72 h after first presentation to study doctor

n/N (%)

n/N (%)