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The horizon for the baseline analysis will be two years.
A baseline analysis will be performed to examine the comparability of groups at baseline for both costs and outcomes.
The baseline analysis will be based on complete cases, with an additional sensitivity analysis using multiple imputation to account for missing data using the ICER procedure within STATA.
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Prior to analyzing DD2 data, a baseline economic analysis will be conducted using existing patient cohort data, data from the Danish National Hospital Register, and data from the Danish Quality Unit of General Practice.
A baseline raw analysis will be performed to evaluate the following parameters and their 95% confidence intervals: ABI (absolute benefit increase), RBI (relative benefit increase) and NNT (number needed to treat).
In order to evaluate the data retrieved from these studies and from the DD2 database, a baseline health-economic analysis will be performed.
Randomisation should ensure that the groups are similar or equivalent in their baseline characteristics; additional multivariate analysis will be used if baseline differences are noted between the two groups.
In case of skewed randomisation (i.e. statistically significant differences in baseline variables), an adjusted analysis will be performed using multivariable logistic regression.
To account for possible baseline imbalances, a secondary analysis will be performed in which comparison of treatment groups for all endpoints will be adjusted for predefined covariates using multiple regressions.
If more than 5% of patients fail to provide post-baseline data, the primary analysis will be complemented by sensitivity analyses exploring potential biases induced by patterns of missingness which will be investigated by logistic regression on comprehensive baseline information.
If an adjustment for possible baseline incomparability is needed, covariance analysis will be performed.
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