Are the selected outcomes clinically important and do they have a prespecified MCID? Are the selected outcomes acknowledged and accepted by the decision-maker concerned? Are subjective endpoints reliable and informative? Are any surrogate or intermediate endpoints being used, and if so, have they ...
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11 Although approximately 70% of the patients with AEs experienced their first AEs within the time period of the first three injections, there were some patients in whom the first AE happened after the seventh injection, indicating that careful administration and observation is needed for the ...
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