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Secondary endpoints Secondary endpoints include the following: Time to 10% relative decline in FVC% predicted, first respiratory hospitalization, lung transplantation, or death from any cause Time to death from any cause Time to first respiratory hospitalization Time to 10% relative decline in FVC Time to lung transplantation Time to 10% relative decline in FVC% predicted Time to first all-cause hospitalization Annualized rate of respiratory hospitalizations Annualized rate of non-elective, all-cause hospitalizations Proportion of participants undergoing lung transplantation during follow-up Change in FVC % predicted from randomization to 12 and 24 months Change in FVC from randomization to 12 and 24 months Change in DLCO uncorrected, from randomization to 12 and 24 months Change in patient-reported outcomes scores from randomization to 12 and 24 months (Leicester Cough Questionnaire, EuroQoL EQ-5D, UCSD-SOB, K-BILD, SGRQ scores) Proportion of participants with and number of treatment- emergent adverse events, serious adverse events, adverse events leading to discontinuation, unanticipated problems Exploratory endpoints Exploratory endpoints are related to home spirometry and include the following: Time to 10% relative decline in home spirometry FVC Time to 10% relative decline in home spirometry FVC % predicted Change in home spirometry FVC % predicted from randomization to 12 and 24 months Change in home spirometry FVC from randomization to 12 and 24 months Comparison between a 10% relative decline captured by home spirometry with the relative change in FVC captured by the next on-site FVC measurement Data and safety monitoring board Safety and oversight will be under the direction of a Data and Safety Monitoring Board (DSMB) that is appointed by the NHLBI

This is in accord with the finding that when skeletal muscle cells in culture, were either transfected with the MGF cDNA or were treated with the MGF carboxy peptide they increased in number but stayed as monocleated myoblasts Yang & Goldspink, 2002)

J Cell Sci 2003

Iron homeostasis and oxidative stress: an intimate relationship

Supports antioxidant defense, tissue repair, and immune system health

Makhutov, E