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These observations led to an amended study protocol designed to improve tolerability of pemetrexed with folic acid supplementation.
This was confirmed in the amended study.
In this amended study, nine eligible patients were treated with 500 mg m−2 indisulam in combination with 1250 mg m−2 BID capecitabine.
Therefore, the dose of indisulam was further reduced to 500 mg m−2 (dose level 7, Table 2a) and an amended study was initiated to investigate safety at repeated cycles.
The amended study was powered to detect a clinically relevant difference between omega-3 facid andd and control groups (arms A, B and E combined versus C, D and F combined) on the primary composite outcome of AVF access failure.
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Since the study drug was stopped before intended study termination in the IDENTITY program and the studies were amended, many study subjects did not have the opportunity to participate until the endpoint visit at 76 weeks.
The study was originally designed as a 52-week, open-label extension of the previous European, phase III study (SPD489-325) [ 7], but the protocol was amended after study initiation in response to revised European Medicines Agency guidelines [ 18].
All the authors discussed and amended the study protocol.
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.
27 We amended our study protocol, and from February 2010, after allocation of 48 women to the in vitro fertilisation with single embryo transfer group, a strict single embryo transfer policy was implemented (that is, single embryo transfer was performed irrespective of the quality of the embryo).
Exclusion criteria included on antihypertensive therapy at time of stroke onset (amended during study to allow inclusion of dysphagic patients on antihypertensive therapy) or an urgent indication for BP lowering, significant co-morbidity, or a life expectancy ≤ six months due to non-stroke causes prior to stroke onset.
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