FULL PROTOCOL TITLE
9.7 statistical methods planned in the protocol & determination of sample size 16. 9.7.1 statistical and analytical plans 16. 9.7.2 determination of sample size 16. 9.8 changes in the conduct of the study or planned analyses 16. 9.8.1 protocol amendments 16. 10. study population 16. 10.1 disposition of patients 16. 10.2 protocol deviations 18 ... ................
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