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Registration

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Trial Status in_development on_going
Last Published August 31, 2020 08:49 AM September 01, 2020 03:57 AM
Experimental Design (Public) A cluster randomised controlled trial design will be applied, using trade districts as clusters for randomization. A cluster randomised controlled trial design will be applied, using trade districts as clusters for randomisation.
Power calculation: Minimum Detectable Effect Size for Main Outcomes Power calculations were conducted as follows. Simulations were performed employing real sales data from January 2014 to August 2019. In these simulations, we assumed that extended opening hours were implemented by trade districts from September 1st 2018, December 1st 2018, and March 1st 2019, thus resembling the dates of the planned experiment, only two years before. For each outlet, the predicted increase in sales was set to be a uniformly distributed rate over the interval (0, 0.3) of mean hourly sales on Saturday afternoons in 2018; and this effect was further weighted by a relative measure of increasing sales on Saturday afternoons as compared to sales in the morning hours. The simulated increase in sales on Saturdays, given a one hour increase in trading hours, was then added to monthly sales data on which we ran regressions with standard errors adjusted for clustering. In the regression models, we also accounted for seasonal variation. With 100 simulations of different block randomizations and random effect sizes, we were unable to produce parameter estimates for wine (mean β=0.030) and spirits (mean β=0.025)  which were not statistically significant at p< 0.05. However, the effect on beer sales (mean β=0.018) was mostly statistically insignificant. Power calculations were conducted as follows. Simulations were performed employing real sales data from January 2014 to August 2019. In these simulations, we assumed that extended opening hours were implemented by trade districts from September 1st 2018, December 1st 2018, and March 1st 2019, thus resembling the dates of the planned experiment, only two years before. For each outlet, the predicted increase in sales was set to be a uniformly distributed rate over the interval (0, 0.3) of mean hourly sales on Saturday afternoons in 2018; and this effect was further weighted by a relative measure of increasing sales on Saturday afternoons as compared to sales in the morning hours. The simulated increase in sales on Saturdays, given a one hour increase in trading hours, was then added to monthly sales data on which we ran regressions with standard errors adjusted for clustering. In the regression models, we also accounted for seasonal variation. With 100 simulations of different block randomisations and random effect sizes, we were unable to produce parameter estimates for wine (mean β=0.030) and spirits (mean β=0.025)  which were not statistically significant at p< 0.05. However, the effect on beer sales (mean β=0.018) was mostly statistically insignificant.
Pi as first author No Yes
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Analysis Plans

Field Before After
Document
Timeline+Diagram.pdf
MD5: 4a435999b9ad8970c23ddf05d0b3e9f0
SHA1: e0d4950fee3cbfe71f619ef339e8d32ef11c0ba9
Title Timeline Diagram
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Documents

Field Before After
Description Short description of study protocol applying the WHO registration form for trial registtration. Short description of study protocol applying the WHO registration form for trial registration.
Public No Yes
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Fields Removed

Documents

Field Value
Document Name Analysis plan - SPIRIT
Custom Type Pre-Analysis plan
File
Analysis+Plan+-+SPIRIT.pdf
MD5: 3c10101d513c8f772cfbef1179d505ee
SHA1: 790da89cb00316ac018803a27f718e887cf07f81
Description The pre-analysis plan is a project protocol developed in accordance with the SPIRIT checklist for clinical trial protocols.
Public Yes
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Field Value
Document Name Timeline Diagram
Custom Type Participant timeline diagram
File
Timeline+Diagram.pdf
MD5: 4a435999b9ad8970c23ddf05d0b3e9f0
SHA1: e0d4950fee3cbfe71f619ef339e8d32ef11c0ba9
Description This diagram gives an overview of the timeline for trading hours in alcohol monopoly outlets in Norway by outlet category, for those eligible for allocation to experimental conditions and those not eligible for RCT.
Public Yes
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