Title and abstract |
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1a |
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1b |
See abstract. No results and conclusions yet since study design paper |
Introduction |
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Background and objectives |
2a |
See Background |
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2b |
See Background |
Methods |
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Trial design |
3a |
See Methods (Study design) |
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3b |
See Methods (Study design) |
Participants |
4a |
See Methods (Study population) |
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4b |
See Methods (Study design) |
Interventions |
5 |
See Methods (Study intervention) |
Outcomes |
6a |
See Methods (Study endpoints) |
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6b |
See Methods (Study endpoints) |
Sample size |
7a |
See Methods (Sample size) |
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7b |
See Methods (sample size) |
Randomization: |
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Sequence generation |
8a |
See Methods (Randomization) |
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8b |
See Methods (Randomization) |
Allocation concealment mechanism |
9 |
See Methods (Randomization) |
Implementation |
10 |
See Methods (Randomization) |
Blinding |
11a |
See Methods (Study endpoints) |
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11b |
Not applicable |
Statistical methods |
12a |
See Methods (Statistical analysis) |
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12b |
See Methods (Statistical analysis) |
Results |
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Participant flow |
13a |
Not yet available (since study design paper) |
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13b |
Not yet available (since study design paper) |
Recruitment |
14a |
See abstract |
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14b |
Not applicable |
Baseline data |
15 |
Not yet available (since study design paper) |
Numbers analysed |
16 |
Not yet available (since study design paper) |
Outcomes and estimation |
17a |
Not yet available (since study design paper) |
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17b |
Not yet available (since study design paper) |
Ancillary analyses |
18 |
Not yet available (since study design paper) |
Harms |
19 |
Not yet available (since study design paper) |
Discussion |
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Limitations |
20 |
Not yet available (since study design paper) |
Generalisability |
21 |
Not yet available (since study design paper) |
Interpretation |
22 |
Not yet available (since study design paper) |
Other information |
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Registration |
23 |
See Trial registration |
Protocol |
24 |
See Main manuscript |
Funding |
25 |
See Acknowledgements |