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No unanticipated toxicities were encountered and overall therapy appeared to be more tolerable after amending the protocol.
For example, the involvement of carers as research participants was advocated by LEAP, and initially implemented by the research team (with time spent drafting information sheets and consent forms, and amending the protocol), before it became clear that the resources needed to obtain high quality empirical evidence would be disproportionate.
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349 350 To reflect the degree of oversight for the trial and adherence to applicable regulation, the protocol should describe the process for making amendments, including who will be responsible for the decision to amend the protocol and how substantive changes will be communicated to relevant stakeholders (eg, REC/IRBs, trial registries, regulatory agencies).
To defend against the aforementioned attacks, we amend the protocol with a stateful variant so that it holds the claimed security properties.
We amended the protocol to accrue 102 patients.
After this high complication rate became evident, the protocol committee decided to amend the protocol.
Accordingly, we amended the protocol so that outpatients completed the daily breathlessness diary for a week at baseline.
We have amended the protocol in December 2009 to allow 3 cycles CAPOX to be administered to bridge time to surgery.
The intervention package described above was piloted, and based on a review of the results a decision was made to amend the protocol by redesigning the benefit package.
Therefore it was decided to amend the protocol and also allow the PTA treatment of other infrapopliteal lesions in nontarget vessels outside of the current study.
We therefore amended the protocol midway through the study (December 5, 2006) to include cases of invasive GCS and GGS infection (year 2).
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CEO of Professional Science Editing for Scientists @ prosciediting.com