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Therefore, none of our study participants had sex reassignment surgery before or during study participation.
In QIBANE, nine of the participants had had a deterioration of neck pain during study participation, as indicated on the comparison of baseline to follow-up assessment, and eleven had experienced an improvement (Table 2).
None of the subjects experienced a cluster headache attack during study participation.
However, none of the subjects experienced a CH attack during study participation, despite the fact that all of the subjects were in a cluster period at the time.
High compliance at baseline was identified as a strong predictor of compliance during study participation (odds ratio (OR) = 6.9, 95% confidence interval (CI) = 5.0 to 9.5, p < 0.001).
Concomitant medication at any point in time and for any duration of treatment during study participation was also allowed in order to reflect routine clinical settings.
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Of the participants in drug treatment during the study participation in Estonia, the majority (92 %) were receiving methadone substitution treatment.
This is illustrated by Table 2, showing high frequencies of toxicities, which accumulated during prolonged study participation.
The four questionnaires (ESAS, PNPC-sv, HADS and NCQ) will be completed at home every four weeks during the study participation.
As shown in Table 3, the frequency of anorexia, fatigue, diarrhoea and PPE was high in the first 50 days on study treatment, and increased significantly during prolonged study participation.
This list will always be accessible to participants in all study arms before, during, and after study participation regardless of whether the participants withdraw from the study.
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