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Tumor volume was measured twice weekly using the formula length breadth height

As a mitigation strategy, if the test for period effect post unblinding was significant, then the statistical model for the primary outcome had to be recomputed only on the data from the first period of the trial (where period effect is taken out)as recommended by clinical practice (3537)

It remains to be seen whether properly conducted randomized clinical trials will strengthen or weaken these associations

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