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Table 2 Comparison of the impact of relaxing different eligibility criteria in patients taking drug D1

From: The “RCT augmentation”: a novel simulation method to add patient heterogeneity into phase III trials

Re-included subpopulations Natural augmentation (number of patients re-included when opening the trial to the specific “real-world population” subgroup) Prediction bias with natural augmentation Mean squared error (MSE) of prediction with natural augmentation
Relaxed eligibility criteria Illness duration between 1 and 3 years 188 0.033 0.818
1 past suicide attempt 190 0.057 0.820
Private practice 159 0.041 0.830
Alcohol abuse 73 0.054 0.836
Drug abuse 65 0.053 0.833
Illness duration between 1 and 3 years + 1 past suicide attempt 339 0.024 0.803
Illness duration between 1 and 3 years + private practice 321 0.024 0.814
Illness duration between 1 and 3 years + alcohol abuse 248 0.037 0.812
RCT population not applicable 0.054 0.852
SOHO “real-world population” not applicable 0.000 0.000
  1. Results for the “RCT population” and SOHO “real-world populations” are displayed as benchmark