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The GACO system may have provided an opportunity to formally enrol patients who were already being followed without formal enrolment.
Patients with soft-tissue sarcoma had to be aged 18 years or older to enrol; patients with bone sarcoma could enrol if they were aged 12 years or older.
Following first communication of a study indicating that moderate hypothermia may be harmful in patients with severe bacterial meningitis [45], we submitted a protocol amendment to the local independent ethics committee (Comité de Protection des Personnes CPP Ile de France IV, Saint Louis, on 15 January 2013) to not enrol patients with bacterial meningitis.
Our finding that low baseline weight and CD4 count and recency of ART initiation are associated with higher mortality is consistent with other studies and points to the need to enrol patients earlier in their disease progression [10], [13] [15].
Four Dutch (non-academic) hospitals will enrol patients.
The present study did not enrol patients with severe sequelae.
This prospective cohort study enrol patients assigned for meniscus surgery.
We are planning to enrol patients during 2011-2014 and follow-up will continue until 2019.
The study was initiated in November 2012 and continues to enrol patients (www.clinicaltrials.gov identifier number NCT01695408).
First, we did not enrol patients with mild ARDS under the Berlin criteria (PaO2/FiO2>200mm Hg).
We could not enrol patients with grade 3 and 4 severe scorpion stings owing to restriction by the ethics committee.
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