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The aim of this evaluation was to summarise and analyse endpoints on fate and behaviour as well as the corresponding test methods for their importance and appropriateness to be implemented into a test strategy on the fate of ENMs.
Propensity-adjusted Cox proportional hazards regression models stratified by age subgroups were used to analyse endpoints of time to death and time to hospital discharge.
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Analysed endpoints were local control (LC), distant brain control (DC), intracranial control (IC) and overall survival (OS).
For primary analysis, we collected and analysed endpoint data on all participants.
Univariate and multivariate DFS analyses (endpoint: recurrence excluding second primary breast tumor) were carried out using Cox proportional hazards regression analysis.
For the patient-reported outcome analyses, DTSQs endpoints were analysed at week 26 using the standard ANCOVA model with treatment, country and previous treatment as fixed effects, and DTSQc endpoints were analysed using an ANCOVA model with treatment, country and previous treatment as fixed effects and baseline DTSQs as covariate.
Another potentially useful approach in exploratory studies where the most sensitive endpoint to the therapy is unknown is to analyse multiple endpoints individually and look for consistency of results across the endpoints.
Similarity analyses between endpoints D and E were also carried out at multiple levels.
Analyses of endpoints and treatment comparisons were performed in a fixed sequential order to control the type 1 error rate for multiple comparisons.
Finally, we analysed all endpoints restricted to the participants who were adherent to the allocated intervention and clinical trial instructions as stipulated in the protocol (figure 1).
In the linear mixed effects model analyses for endpoints that constituted changes from baseline, the baseline value of the outcome was also adjusted for.
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Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.

Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com