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The ProVIDe study is a multicentre, two-arm, double-blind, parallel, randomised, controlled trial.
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The EAC considered that only three of the provided studies were relevant to the decision problem.
Indirect comparisons may then be used to determine the relative effectiveness, provided studies are adequate for indirect comparisons (§ 5 par. 5 AM-NutzenV).
Information on the four national data sources that provided information for the study is provided in detail elsewhere.
"The preparation contains all manner of neurotransmitters, but excitatory and inhibitory terminals differ in structure, so the picture provided by the study is that of an 'average' terminal without regard for the neurotransmitter".
Since no patient information was provided, the study was approved by the ethics board of the Pennsylvania State University as research not involving human participants (IRB no. 35170).
The rationale for the study is provided and the methods proposed seem correct.
The structure of the study is provided in figure 1 and described in detail below.
An overview of the chronology of the study is provided graphically [Figure 1].
A detailed description of the methodology of the study is provided elsewhere [ 28].
The custom code used for the current study is provided in the Supplementary Data.
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