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Anecdotal feedback from potential participants during the recruitment process has led us to consider amending the study brochure to use less clinical, more inclusive language.
They can contribute, for instance, to amending the study protocol and design, a more substantial scientific contribution that later impacts the field procedures, although any amendment should be done according to the rules defined by or with collaborators: " Most of time, the sponsor comes with the study protocol already done.
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All the authors discussed and amended the study protocol.
During the original study, it was decided to amend the study protocol to include the follow-up during Years 2 5 of the second consecutive LNG-IUS.
Figure 1 shows the anticipated timing to gain approvals, run the focus group and amend the study based on focus group feedback.
In 2006 we amended the study protocol by asking the children to write each measurement from the Piko meter in the symptom diary and encouraged the community workers to check these carefully to ensure compliance and technique.
After receiving approval from the JHU Institutional Review Board in July 2009 to amend the study protocol, the HFS team began training CHWs to distribute combined hormonal contraceptive pills and condoms, in accordance with Bangladeshi government protocols for in-home provision of contraceptives by community-based workers.
Owing to the unexpected early occurrence of DLT at dose level II and the rather big gap in Caelyx dosage between levels I and II, we decided to amend the study protocol and include a dose level Ia (Caelyx 20 mg m−2).
All authors were involved in planning the study and amending the manuscript.
He also spoke of a committee to study amending the Constitution or drafting a new one.
Both authors were equally involved in planning the study, drafting, and amending the manuscript.
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