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Protocol amendments were approved by the IRB before implementation or submitted to the IRB for information, as required.
Protocol amendments are often necessary in clinical trials.
Protocol amendments are listed in Additional file 1.
Protocol amendments occurring after the study start are summarized in the Supplementary Data online.
Protocol amendments implemented after the study commenced are summarised in (Additional file 2: Table S1).
Protocol amendments will be managed by the NCTU and communicated to the trial team.
Protocol amendments implying substantial changes were approved by the appropriate IEC/IRB prior to implementation.
Protocol amendments allowed treatment with pegloticase for a maximum of 31 months.
Protocol, amendments, and informed consent documents were approved by independent local ethics committees and implemented according to good clinical practice (9) and the Declaration of Helsinki (10).
There were four protocol amendments during the study.
By limiting the use of HFCs, the new Montreal Protocol amendments could reduce global warming by 1°F by 2100.
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