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Inclusion criteria included adult patients capable of providing consent capable of complying with the study protocol, and suffering from back pain due to adult degenerative scoliosis.
All participating units had to commit to complying with the study protocol and were required to be within the catchment area for available emergency ambulance services.
The studies in the present review only excluded participants with serious mental and physical conditions that would prevent participants from complying with the study routines safely, pregnancy and related conditions and use of other weight-related treatments.
Other inclusion criteria comprise: a user of bifocal, trifocal or progressive-lens glasses 3+ times/week when walking outdoors; having had a review by an optometrist or ophthalmologist in the last 12 months; not currently using single-lens distance glasses; and indicating that they are at least 'quite confident' of complying with the study recommendations.
Monitors will ensure that the investigational team is complying with the study protocol and GCP standards, that the data and AEs are accurately and appropriately recorded in the eCRFs, that severe AEs (SAEs) are forwarded to the trial coordinator and the investigational drug provider, and that those meeting reporting criteria are forwarded to the institutional review board (IRB).
Other criteria for a peer mentor include owning a mobile telephone, being willing to attend a 2-day training and complying with the study protocol.
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Offspring were excluded if they were unable to comprehend or comply with the study protocol.
They also had to be willing to comply with the study procedures.
None of these conditions or features considered to potentially compromise the ability to comply with the study were exhibited by any of the IBS patients.
Patients and parents who were willing to comply with the study procedures were included.
All participants provided written informed consent and agreed to comply with the study protocol.
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