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Table 1 Summary of studies included for which data was received

From: Data-sharing and re-analysis for main studies assessed by the European Medicines Agency—a cross-sectional study on European Public Assessment Reports

Study acronym Study Study drug Comparator drug Sponsor Design Study duration (weeks) Number of arms Participants Percentage of women Mean age of participants (SD)
ENDURANCE-4 Asselah, 2018 [36] Glecaprevir/pibrentasvir NA AbbVie Deutschland GmbH & Co. KG Non-controlled cohort study 24 1 121 36.4 52.66 (11)
M41008−1002, Mrowietz, 2017 [37] Dimethyl fumarate Placebo/dimethyl fumarate + ethyl hydrogen fumarate Almirall, S.A. Superiority and non-inferiority (head to head) 16 3 699 35.3 44.2 (14.5)
ERC 231 Archer, 2015 [38] Dehydroepiandrosterone (DHEA) Placebo Endoceutics Superiority (head to head) 12 3 255 100 58.5 (6)
Clarity Giovannoni, 2010 [39] Cladribine Placebo Merck Serono International S.A. Superiority (head to head) 96 3 1326 67.6 38.6 (10)
NN7088-3885 Trakymiene, 2020 [40] Turoctocog Alfa pegol NA Novo Nordisk A/S Non-controlled cohort study 26 1 68 0 6 (3.3)
SUSTAIN 2 Ahren, 2017 [41] Semaglutide Sitagliptine Novo Nordisk A/S Superiority and non-inferiority (head to head) 56 4 1231 49.4 55.1 (10)
SUSTAIN 5 Rodbard, 2018 [42] Semaglutide Placebo Novo Nordisk A/S Superiority (head to head) 30 4 397 43.9 58.8 (10.1)
TRANSFORM-1 Fedgchin, 2019 [43] Esketamine Placebo Janssen-Cilag International NV Superiority (head to head) 4 3 346 70.3 46.3 (11.6)
SUSTAIN-1 Daly, 2019 [45] Esketamine Placebo Janssen-Cilag International NV Superiority (head to head) 16 2 705 64.8 46.1 (11.1)
SUSTAIN-2 Wajs, 2020 [44] Esketamine NA Janssen-Cilag International NV Non-controlled cohort study 52 1 802 62.6 52.2 (13.7)