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The newly optimized nonhuman primate model described will facilitate preclinical efficacy assessments of novel therapeutics for CNV.
The efficacy analysis was performed in the 'intent to treat' (ITT) population defined as randomised subjects who received study treatment and completed at least one post-baseline efficacy assessments.
Toxicology is equally as important as efficacy assessments in drug development because the majority of drug projects still fail due to toxicity or safety reasons.
No safety or efficacy assessments were made.
Efficacy assessments included measures of PTSD, anxiety, depression, sleep quality, resilience, and disability.
[18F] FDG-PET imaging was included in the clinical efficacy assessments.
Efficacy assessments included the Yale-Brown Obsessive Compulsive Scale (YBOCS) and the Clinical Global Impressions-Improvement scale.
In all six studies, efficacy assessments included the YMRS total score (primary efficacy outcome) and the MADRS Total score.
This means, during the period of agents' efficacy assessments, a relatively constant natural pest population was present.
Weekly efficacy assessments [Hamilton Anxiety Scale, Hospital Anxiety and Depression Scale (HADS), Self Assessment of Resilience and Anxiety (SARA)] and safety evaluations were conducted.
Efficacy assessments included change in adjusted inflammatory neuropathy cause and treatment (INCAT) score, grip strength and Medical Research Council (MRC) sum score.
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