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The SAC also discussed and approved revisions of the protocol.
CAE, CAJ and ASW participated in the development of the study design and revisions of the protocol.
Recent revisions of the protocol are listed in Additional file 2. Whole genome amplification was performed using 50 ng of genomic DNA with reagents from the Repli-g midi kit (Qiagen), according to the manufacturer's instructions.
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Finally, phase 3 was after revision of the protocol (August 1st to October 31, 2011) (revised CPOE protocol group), following a plan-do-study-act cycle.
Major revision of the protocol was not needed to triage OHCA patients for CFR dispatch.
The transplantation team has not changed but a revision of the protocol had done during this interval (restriction in transfusion and volume infusion, immunosuppression based on CysA and TAC and use of basiliximab for patients with high risk for AKI).
We also acknowledge the contribution of J.J. Beckeringh, PhD, for the final editorial revision of the protocol.
The session will be recorded and minuted, and recommendations used to inform revision of the protocol as needed.
At the meetings, the intervention program committee will present the agenda, after which important issues, such as revision of the protocol or stopping of the study, will be discussed.
Revisions to the protocol are documented and justified with notation of when in the process the revisions were made.
Specifically, the need to obtain approval from all national regulatory bodies and ethics commissions was source of unexpected delays and called for numerous revisions of the study protocol.
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