5 Suggestions Which will alleviate All your PDE4B Complications

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Версія від 10:24, 28 травня 2017, створена Drawer9parade (обговореннявнесок) (Створена сторінка: Safety evaluation Adverse events Adverse events (AEs) and SAEs are defined according to the Dutch Medical Research Involving Human Subjects Act 2006. AEs will b...)

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Safety evaluation Adverse events Adverse events (AEs) and SAEs are defined according to the Dutch Medical Research Involving Human Subjects Act 2006. AEs will be monitored throughout the n-of-1 trial. All SAEs and Suspected Unexpected Serious Adverse Reactions (SUSARs) occurring during the study and either reported spontaneously or as part of the AE monitoring will be followed up by the principal investigator and will be reported separately to the Medical Ethics Committee (MEC). Unblinding will occur if there is reason to believe a SAE or SUSAR was due to the study medication and if the patient cannot be treated without knowing which treatment they were receiving. Unblinding and the reason for unblinding will be recorded. All AEs, SAEs and SUSARs will be followed up until they have abated or a stable situation has been reached. Removal from the trial and replacement of participants Participants will be removed from the study if informed consent is withdrawn. The investigator can decide to withdraw a participant from the n-of-1 trial for urgent medical reasons. Specific criteria for withdrawal of individual participants consist of: The occurrence of a SAE or SUSAR; A myasthenic crisis or worsening of symptoms requiring any treatment other than the trial medication; A need to undergo thymectomy before the end of a cycle in the multiple crossover phase of the trial. Participants who are withdrawn from the study will be followed up until their planned end of the n-of-1 trial to assess AEs of the trial medication. The cycles completed before a participant's withdrawal from the study will be analysed as part of the trial. Participants who fail to complete a single cycle of the multiple crossover phase will be replaced. Premature termination of the study The study will be terminated prematurely if SAEs occur that are deemed in all likelihood to be caused by the trial medication. Analysis Effect of add-on ephedrine compared with placebo on muscle strength and endurance for all patients The average QMG scores for baseline, placebo and ephedrine periods of the multiple crossover phase will be described for all n-of-1 trials combined. A linear model for QMG score with fixed PDE4B effects for treatment and patient will be fitted for all patients in the trial combined. All treatment effects for the study population will be tested at the 0.05 level. If we can demonstrate a significant treatment effect in the study population, we conclude that, on average, ephedrine has an effect on the four patients enrolled in the study. If this is the case, we will proceed to test if there is a significant treatment effect in the population from which the four patients were sampled. To this end, we will fit a linear mixed model for QMG score with fixed effects for treatment and patient, and also a random treatment effect.