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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)