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the competent authority shall take responsibility for generating the randomization scheme and ensuring it is implemented correctly.
den kompetente myndighed skal påtage sig ansvaret for at udarbejde randomiseringsplanen og sikre, at den gennemføres korrekt.
the primary efficacy parameter of the trial was overall survival, defined as the time from randomization to death from any cause.
den primære effektparameter for studiet var samlet overlevelse, defineret som tid fra randomisering til død, uanset årsag.
the primary efficacy endpoint of the study was ttp, defined as the time from randomization to first documentation of objective tumour progression.
undersøgelsens primære effektendepunkt var ttp, defineret som tiden fra randomisering til første dokumenterede objektive tumorprogression.
studies i, ii, iii, v, and vi required patients to have at least 12 tender and 10 swollen joints at randomization.
i studie i, ii, iii, v og vi skulle patienterne have mindst 12 ømme og 10 hævede led ved randomisering.
all patients received standard of care analgesia during treatment patients received low-dose acetylsalicylic acid prior to randomization and throughout the two cabg surgery studies.
alle patienter fik standard smertelindrings -behandling under forløbet.