Blinded Sample Size Re-Calculation Sample Clauses

Blinded Sample Size Re-Calculation. A sample size re-calculation will be performed to evaluate on a blinded basis the study assumptions used to calculate sample size. A sample size re-calculation committee (SRC), comprised of Sponsor personnel and the study’s blinded statistician, will be established to re- calculate sample size based on blinded assessment of study assumptions. The SRC will review available data (e.g., baseline characteristics, study drug discontinuations, variability in 6MWD change from baseline, intra-patient autocorrelations of 6MWD) when approximately 100 patients have been enrolled in the study. The Sponsor may increase the sample size of the study up to approximately 200 patients. An increase of sample size within this range will be documented in a note-to-file to the investigators/IRBs/ECs (as appropriate) and will not require a protocol amendment. Because these analyses will be based on pooled, blinded data they will not impact the Type I error rate. An appendix to the Statistical Analysis Plan (SAP) will present details regarding the planned re-calculation of sample size.