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Randomisation was generated electronically through the electronic case report form according to a predefined randomisation sequence (implemented by a statistician).
Another limitation is that the duration of additional telephone consultations was self-reported by study staff on the electronic case report form.
Data were collected via an electronic case report form from 129 sites in ten European countries.
Data were collected using an electronic case report form.
A specific electronic case report form (eCRF) was developed by Lincoln, Paris, France, using software developed in collaboration with JDC.
Study variables were collected via an electronic Case Report Form.
Data were collected online using an electronic case report form.
All data are stored in an electronic case report form.
The incidence and severity of all adverse events was recorded in the electronic case report form.
All data were collected using a standardized electronic case report form by dedicated clinical research assistants.
Collected data went through de-identification process using the electronic case report form system.
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