Furthermore, training in completion of data collection forms and monitoring of completion of questionnaires will occur at each site and update courses will be offered as required.
Close-out of the study will occur after completion of all month 12 surveys or non-response by a participant for 1 month following the month 12 email and telephone notification.
Randomisation to study condition will occur following the completion of baseline assessment.
Randomization and baseline study procedures (hyperglycemic clamp and OGTT) will occur after successful completion of the run-in.
A short debriefing session will occur at the completion of the training session to discuss participants' general well-being, motivation and any concerns they may have regarding the training programme.
Randomisation will occur immediately following the completion of the baseline interview with the child, with participants informed at this time.
Randomisation will not be stratified and will occur automatically at the completion of the baseline survey by taking the next allocation of the generated schedule.
Randomization to receive either Pharmacist or Pharmacist+HP assignments for the first year will occur after consent and completion of all baseline data collection.
Re-assessment will occur at 14 weeks (following completion of physiotherapy rehabilitation in the PT group) and 24 weeks post surgery via administration of questionnaires completed online or via post.
Actual randomisation will occur during surgery, prior to case completion and will be carried out by the pharmacy technician using an internet-based randomisation system that ensures concealment.
