SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials

Melanie Calvert, Madeleine King, Rebecca Mercieca-bebber, Olalekan Lee Aiyegbusi, Derek Kyte, Anita Slade, A. W. Chan, Ethan Basch, JA Bell , AV Bennett , V Bhatnagar , J Blazeby, A Bottomley , J. Brown, L Campbell, JC Cappelleri , H Draper, A Dueck , C Ells , L Frank Robert M. Golub, I Griebsch, Kirstie Haywood, A Hunn, BL King-Kallimanis , L Martin, S Mitchell , T Morel , L Nelsen , Josephine M. Norquist, D O'Connor, Michael J Palmer, D Patrick, Gary Price, A Regnault , Ameeta Retzer, D Revicki, R Stephens, Grace Turner, A Valakas , Galina Velikova, Maria Von Hildebrand, Anita Walker, Linda Wenzel, Jane A Scott

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