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The study will be conducted at regional and long-haul operations within the study area, which includes all counties in the State of California. Regions and long-haul operations that can be feasibly reached in a two-year period will be selected for this multicenter study.
All study participants will be blinded to the hypothesis of the study, the hypothesis of each treatment group, and the specific hypothesis to be tested. Study data will be collected during normal business hours in the study region, with procedures identical no matter which driver study group the participant represents. Participants will be asked to maintain their usual work schedules and follow their usual work routines and patterns.
The study utilizes a randomized controlled design. Drivers will be randomized into two groups to be dosed with a single topical application treatment or a placebo within one hour of reporting to the local data collection center
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Dr. Mary Ann Veri will be the principle investigator for this study. Dr. Veri is experienced in designing and conducting clinical studies. Dr. Veri also has experience researching the impact of circadian rhythms on occupational and geographical distribution and the pharmacokinetics and pharmacodynamics of pharmaceuticals, topical antimicrobial therapies and specific foods.
She will be assisted by Dr. Marcia Chambers who will assist with the practical aspects of conducting the study in the field, and Dr. Raymond Witmer who will assist with the statistical analysis of the results. Research personnel will be recruited from Oregon State University in Corvallis, Oregon. They will be trained in the methods to be used in the study.
Study details will be explained verbally and in writing. Written informed consent will be obtained from the participant in the first session. Adult participants will be asked to read and sign the consent form as well as have their parent or guardian sign the child consent form if age less than 18 years. d2c66b5586