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All authors contributed to manuscript revision and read and approved the submitted version

The current regulatory impact analysis on SE reports indicates that whatever data are submitted, it should include test protocols, quantitative acceptance criteria, and test results as well as clearly identify when national or international standards are used to test the new and predicate products in addition to explaining any deviations from the standard or stating if no testing standards were used

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A lower dose of 150 mg once daily may be as effective as twice-daily dosing