The hazard ratio exp(θHR), as defined in (9) depends on the threshold (c), the Wiener process parameters (σ2, θA and θB) and time t. The slopes, as depicted on the left, though not drastic, can dramatically impact the resulting sample size calculation, as depicted on the right. We have found in our Wiener process simulation that choosing a large t results in sample size estimates that are generally consistent with our simulations. In the top panels we set σ = 0.5, θA = 0.2, θB = 0.1 and vary t and c. In the bottom panel we σ = 0.5, t = 10, θB = 0.1, and vary δ = θA – θB.