Sentence examples for amended to the protocol from inspiring English sources

Note: All changes in eligibility criteria were amended to the protocol during the trial and before breaking of the blinding.

Two eligibility criteria and two exclusion criteria were revised and amended to the protocol in August 2006 and April 2007.

As amended to the protocol, the previous primary outcome (improvement of glycemic control of at least 1% in HbA1c value from baseline to the end of the long-term phase) was assessed as a secondary outcome.

Due to an advice of the advisory board, the analysis of the primary outcome parameter was changed and amended to the protocol in November 2008 into 'change of glycemic control', defined as the difference in HbA1c value from baseline to the end of the long-term phase.

Subsequently, as these drugs became available throughout the countries participating in the trial, the protocol was amended to reflect the evolution of the standard of care and to allow inclusion of patients with up to four lines of prior systemic therapy for mCRC.

Given the early discontinuation of the first three patients, the protocol was amended to shorten the first cycle to a 14-day cycle to obtain a pharmacokinetic profile after 14 days of multiple dosing of LY2457546.

However, after treatment of the first 40 patients, of whom 20 were randomised to the combination treatment arm, the protocol was amended to reduce the dose of IL-2 3 IL-2 3days per week, 2 weeks on and 2 weeks off, because of the onset of AEs.

During the study the protocol was amended to modify the inclusion criteria.

In order to fully characterise the elimination phase, the protocol was amended to increase the time period of follow-up after dosing from 48 h to 144 h.

After it was noted that infusion reactions were common with the first dose, the protocol was amended to give the first infusion of obinutuzumab over a 2-day period.

For this reason, the protocol was amended to remove the run-in period and to perform randomisation on the day of screening if the subject was eligible.