Planned Analysis Clause Samples

Planned Analysis. The primary analysis will occur 6 months after the last patient in the cohort has started study treatment. The final analysis will occur 1 year after the last patient in the cohort has received her last dose of study treatment. Additionally, an interim safety analysis may be performed after the first 12 patients are enrolled between Cohorts A and B and have completed 2 cycles of therapy. If results from Study ▇▇▇▇-▇▇-▇▇▇ (NCT03307785) are available and support the feasibility of the starting dose regimens in the current trial, the safety interim analysis will not be performed.