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Compliance with Good Clinical Practice and scientific integrity will be managed by the study management team through regular and ad hoc meetings.
Each statement was discussed at length by the study management group, all of whom agreed on the final set of 42 statements.
These random allocation tables were generated by the study management team and integrated into the QFL computer system where they were not accessible to coaches or participants.
This was an overestimate of the number of cases actually reported once the study had started, and the study duration has therefore been extended to 4 years after a review of initial recruitment by the study management group.
Statements for round 1 of the Delphi process were generated by the study management group in a team workshop, which comprised 7 clinical researchers (2 physiotherapists, 1 occupational therapist and 4 geriatricians) with an interest in rehabilitation of frail older people.
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The provider will inform the study management by an enrolment fax and arrange for the first session within a week of inclusion.
The study management was overseen by a scientific steering committee.
The study management was executed by Daiichi Sankyo Europe GmbH, Munich as sponsor via a contract research organization (SSS International Clinical Research GmbH, Munich, Germany).
Subjects were instructed to use the device on a daily basis and to verify the accuracy of the glucose measurement with a home blood glucose meter (provided by the study) before making management decisions (as per the regulatory labeling of the devices).
After completion of the blinded use, subjects were instructed to use the device on a daily basis and to verify the accuracy of glucose measurements with a home blood glucose meter (provided by the study) before making management decisions (as per the regulatory labeling of the devices).
Procedures specifically conducted by the CTU team (eg, data management, study management and study monitoring) will be conducted in compliance with CTU SOPs.
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