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Bhat, O
Modification of the protocol Any modifications to the study protocol that may influence study conduct, patient benefit, or safetysuch as changes in study objectives, design, participant population, sample size, procedures, or major administrative aspectswill require a formal amendment
doi: 10.1111/joim.12161 559 HoadASpickettGElliottJNewtonJ
Diabetes 53 , 535-P (2004)
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