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Abbreviations ATMP: Advanced therapeutic medicinal product CHMP: Committee for medicinal products for human use COMP: Committee for orphan medicinal products DFS: Disease-free survival EFS: Event-free survival EC: European Commission EMA: European medicines agency EPAR: European public assessment report EU: European Union EUMRN: EU medicines regulatory network FEV: Forced expiratory volume ITT: Intention-to-treat population MAA: Marketing authorization application MAH: Marketing authorization holder MS: Member state ODD: Orphan drug designation OMAR: Orphan maintenance assessment report OMP: Orphan medicinal product ORR: Objective response rate OS: Overall survival pCR: Pathological complete response PFS: Progress-free survival PRAC: Pharmacovigilance Risk Assessment Committee PRIME: Priority medicines RCT: Randomized controlled trials RWD: Real world data RWE: Real world evidence SME: Small and medium sized enterprises US: United States References Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products

Abstract Background It has been demonstrated that acute GPLC supplementation produces enhanced anaerobic work capacity with reduced lactate production in resistance trained males

doi:10.21037/atm-20-6757 34

some patients require a lower dose of 50 mg/kg/day due to the side effect of fishsmelling body odour resulting from the drug