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Details of the main study protocol have been published previously.
The main study protocol was approved by the Ethics Committee (H‐B‐2008‐093) and the Danish Data Protection Agency (2008‐41‐2599).
Sensitivity analyses by treatment received, excluding main study protocol violators (n=23) and including only countries where patients demonstrated good compliance, did not significantly alter the conclusions and thus these data are not shown here.
The Trial Steering Committee TSCC) responsibilities are to approve the main study protocol and any amendments, monitor and supervise the trial towards its interim and overall objectives, review relevant information from other sources, consider the recommendations of the DMEC, and resolve problems brought by the trial co-coordinating centres.
The Steering Committee will approve the main study protocol, monitor and supervise the trial towards its interim and overall objectives, review relevant information from other sources, consider the recommendations of the DMC, and resolve problems brought by the trial co-ordinating centres.
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The main study protocol-related reason against participation was additional time needed [ 12, 18, 19].
In the main study, many protocol adjustments and additional actions were executed to increase the response rate of this specific population: printed questionnaires were developed in Dutch and English and services of an interview bureau were enlisted to conduct telephone interviews in Turkish and Arabic.
The resulting curriculum and intervention then moved into the main research study protocol, described elsewhere.
MAIN OUTCOMES MEASURES:Study protocol and randomization effectiveness, exercise safety and adherence, and progressive intensity of the ACTIVE training procedures.
The study protocol and main results have been reported previously.
NB has co-supervised the telephone survey and assisted in data analysis and drafting the study protocol and main paper.
More suggestions(15)
core study protocol
main study instruments
main study design
main immunosuppression protocol
main routing protocol
main study group
main signaling protocol
main study population
main study publication
main study parameter
main intervention protocol
main study region
main study visit
main communication protocol
main phase protocol
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