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The key to the randomization list will remain with Marinex International Sp. z o.o. until the last study participant completes the trial.
These two sets of within-study variances were then ranked, and the first study was taken to have the largest pair of simulated variances, and so on, until the last study had the smallest pair of simulated within-study variances.
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This allows for identification of trends over time with higher reliability and avoids the loss of precious information in case patients do not remain in the study until completion or the last study measure does not pass quality control.
All adverse events (AEs) were reported until 30 days after the last study drug injection.
Patients were evaluated for adverse events during therapy and until 28 days after the last study drug dose.
Patients were evaluated for AEs during therapy and until 28 days after the last study drug dose.
Long-term follow-up will comprise assessments at 12-week intervals beginning 24 weeks after the last study treatment and continuing until death or study end.
Adverse events (AEs) were monitored from the signing of informed consent until completion of the last study-related procedure.
Patients are followed for bleeding events until the last dose of study drug, and for 1 month (30 days) following the last dose of study treatment for all other secondary endpoints.
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