{
  "study": "SIMBE01",
  "synthetic": true,
  "design": "2x2 crossover, sequences TR and RT",
  "dose_mg": 100,
  "washout_days": 14,
  "periods": 2,
  "planning": {
    "cv_pct": 25,
    "gmr_pct": 95,
    "lower_pct": 80,
    "upper_pct": 125,
    "alpha_one_sided": 0.05,
    "ci_level_pct": 90,
    "n_evaluable_80": 28,
    "n_evaluable_90": 38,
    "power_90_achieved": 0.9089,
    "power_80_achieved": 0.8074,
    "dropout_pct": 5,
    "n_enrolled": 40,
    "pa_abe_min_power": 0.8,
    "pa_abe_cv_pct": 29.81,
    "pa_abe_gmr_pct": 92.32,
    "pa_abe_n": 28
  },
  "randomization": {
    "seed": 2026,
    "method": "permuted blocks (blockrand 1.5)",
    "block_size": 4,
    "n_blocks": 10,
    "n_TR": 20,
    "n_RT": 20,
    "max_running_imbalance": 2
  },
  "software": {
    "PowerTOST": "1.5-7",
    "blockrand": "1.5"
  }
}
