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Sites collect a core set of data that includes demographics, disease activity, medical history and previous medications at enrolment; safety data are collected at each study visit every 6 months for a minimum of 8 years.
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The Sponsor reserves the right to discontinue this trial at any time for failure to meet expected enrolment goals, for safety or any other administrative reasons.
Screening, informed consent, enrolment, randomization, immunization and safety assessment were done as previously described [4], [10].
There was no imbalance between age, sex and baseline clinical safety tests at enrolment between the various groups (Table 1).
An interim analysis will be performed after the enrolment of 20 patients for safety reasons.
A sample size of 300 subjects was planned for enrolment for descriptive evaluation of safety of the vaccine.
At no time, did the Data & Safety Monitoring Board recommend the study to be put on hold or enrolment to be discontinued due to safety issues related to the study medication.
Similarly, G6PD deficient and pregnant individuals were excluded prior to enrolment in all trials and therefore safety of TQ under these circumstances is not explored.
As described in a dedicated DSMB charter, it will be responsible for regularly review the results regarding the enrolment of patients, and the efficacy and safety of AL.
In investigator-sponsored trials and product registries (intensified monitoring) for which no enrolment figures are available, the sanofi-aventis safety database contains an additional 75 individuals with malignancies, including nine cases of breast cancer.
For the university, this isn't about student safety – it's about future enrolments, profits and reputation.
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Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.

Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com