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The applicant asserted that in a post-procedural questionnaire in the CYTALUX® Phase 3 study for ovarian cancer, investigators self-reported achieving complete R0 (no gross residual disease) resection in 62.4% (68 of 109) of patients

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For those with Barth syndrome, the answer is yes There was a very small study—which is understandable given how rare this disease is The study was called the TAZPOWER trial that had 12 males with genetically confirmed Barth syndrome, and they received 40 mg of the equivalent of SS-31 subcutaneously once daily in a randomized double-blinded placebo-controlled crossover design A crossover designs allows you to give 6 people a treatment, the other 6 would get the placebo, you would run them out, and then you would do a washout and then flip it So, it’s more statistically powerful It was followed by an open-label extension that ran for almost 4 years What were they measuring in these people, and what were the results