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It will also aid in the initial protocol design for the pilot study.
Like the controls, mice that had received just the drug but no parasites in the initial protocol also got sick from the challenge dose of Plasmodium, the team reports online today in Science Translational Medicine.
The patients were given vaccine doses identical to the ones they received in the initial protocol.
JOH, RT and IS were involved in the initial protocol design, patient recruitment and assessment.
The assessment of quality of life was planned in the initial protocol version but was not further pursued.
In the initial protocol patient follow-up included visits at 30 days and visit or telephone follow-up at 6 months.
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JM was involved in drafting the initial protocol and liaised with staff at NUHT throughout the project.
DC participated in the extensions to the initial protocol and in the interpretation of the results, and revised the paper.
In this qualitative phase of the study, the initial protocol was discussed in one focus group with 12 low vision health care workers (social workers and psychologists) and two focus groups with each 4 patient representatives (one in the Netherlands and one in Belgium).
This observation resulted in a major change to the initial protocol, namely not requiring the wearing of a PPS for defibrillation.
The halt to recruitment resulted in a smaller sample than planned, with more women in the PMU group, due to the initial protocol of not making follow-up calls to those booked into the TMH for the first six months of recruitment.
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