Table 2 General Reporting Characteristics

Randomised, controlled (including cluster- and community-randomised)

37

(84.1)

  Placebo-controlled

12

(32.4)

  Treatment-controlled

24

(64.9)

  No treatment-controlled

1

(2.7)

  Blinded (including double-, single-, and partially-blinded)

21

(56.8)

  Open-label

10

(27.0)

  NDA

6

(16.2)

  Phase I

1

(2.7)

  Phase III

3

(8.1)

  NDA

33

(89.2)

Non-randomised, single-arm

6

(13.6)

NDA

1

(2.3)

By multiple national and external ECs/IRBs (local regulatory authorities, local IRBs, national ECs, international ECs, external national ECs, and external IRBs)

24

(54.5)

By multiple local (local regulatory authorities, local IRBs, national ECs)

1

(2.3)

Only by local EC/IRB

13

(29.5)

Only by national EC

1

(2.3)

NDA

5

(11.4)

Good Clinical Practice

13

(29.5)

Declaration of Helsinki

9

(20.5)

National/local regulatory requirements

7

(15.9)

Good Laboratory Practice

1

(2.3)

n/a (Conference abstract)

2

(4.5)

NDA

27

(61.4)

CT registration^b

21

(47.7)

CT publications including supplementary files

9

(20.5)

Protocol as supplementary file^c

6

(13.6)

Abstract

18

(40.9)

Methods

41

(93.2)

 Eligibility

27

(65.9)

 Ethics

34

(82.9)

Results

15

(34.1)

Discussion

1

(2.3)