Participants were asked to rate their overall global assessment of pain therapy with study treatment on a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.

Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for the primary parameter after the 0 hour Baseline visit.

Number of hours per day with average pain intensity less than or equal to 4 was measured on a 11-point Numeric Rating Scale (NRS) (range 0 to 10, 0=no pain; 4=mild pain; 10=strongest pain imaginable). If the participant was sleeping at time of measurement, pain intensity was assumed to be less than or equal to 4.

Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for the primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable for this measure at specified time point.

Nursing staff asked the participants to rate their current pain intensity on 11-point NRS (range 0 to 10, 0= no pain; 10= strongest pain imaginable).

Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable for this measure at specified time point.

Participants were asked to enter the time in hours spend out of bed during the last 24 hours in the participant diary.

Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable for this measure at specified time point.

Participants were asked to describe their time schedule for particular steps of mobilization by answering specific questions in the participant diary.

Data was not statistically summarized but reported in individual participant listing. Due to excessive missing data it was not possible to calculate valid results for the different stages of mobilization.

Participants were asked to give their overall global assessment of pain therapy with study treatment using a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.

Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable for this measure at specified time point.

Physicians were asked to give their overall global assessment of pain therapy with study treatment using a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.

Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'n' signifies those participants evaluable for this measure at the specified time point.

Nursing Staff were asked to give their overall global assessment of pain therapy with study treatment using a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.

Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'n' signifies those participants evaluable for this measure at the specified time point.

Physicians were asked to rate the participant's ability to undergo physiotherapy or mobilization by responding to following questions of a questionnaire: Part 1 A- Does the surgical procedure performed allow the mobilization of the participant, C- Was the mobilization of the participant limited due to pain, D- Is the participant in a condition to undergo physiotherapy; Part 2 A- Was it possible to mobilize the participant sooner than with other pain therapies, B- Does the participant move more, C- Is the participant less afraid of moving. For Part 1-Question C, 'Partial' indicates that mobilization of participant was moderately limited due to pain.

Efficacy analysis set included all participants who received the study treatmentat least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'n' signifies participants evaluable at specified time point for specified item.

Physicians were asked to evaluate the IM for fentanyl-ITS (IONSYS) by responding to following questions of a questionnaire: Part2 D- Would you use IONSYS again, E- Would you prefer IONSYS to intravenous patient controlled analgesia (IV PCA); Part3 A- Was IM easy to understand, B- Did IM help you to use system properly.

Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure.

Nursing staff were asked to evaluate the IM for IONSYS by responding to following questions of a questionnaire: IM A- Was IM easy to understand, B- Did IM help you to use system properly; IONSYS PCA A- Is system easy to handle, B- Did participant need help in using system, C- Do you feel confident using IONSYS; IV PCA- Are you experienced in using IV PCA; IONSYS PCA D- Could participant get mobilized sooner, E- Does participant move more, F- Is participant less afraid of moving, G- Were hospital logistics for IONSYS easier to handle.

Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit.

Participants were asked to evaluate the IM for IONSYS by responding to following questions of a questionnaire: A- Is IONSYS easy to use, B- Were you able to operate the system by yourself after receiving instructions, C- Have you found button yourself, D- Was pressing button easy, E- Have you heard system's beeps, F- Was IONSYS IM easy to understand, G- Did IM help you to use system, H- Did you have problems falling asleep, I- Could you move easily in bed, J- Did system bother you during physiotherapy, K- Do you perceive use of such system as modern treatment standard.

Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit.

The PPP33 questionnaire has an overall score and 8 subscales that represent different aspects of the post-operative quality of life: information, autonomy, communication, physical complaints, pain, rest, fear and accommodation. Answers to individual question are scored with values 1 to 4. Summary scores are calculated by adding values for each question. Subscores ranges depend on the number of questions evaluated (2 to 7 questions). The overall score ranges from 1 to 100. Higher scores indicate less pain.

Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for the primary parameter after the 0 hour Baseline visit. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.