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Table 1 Enrolment and analysis populations

From: Performance of a sensitive haemozoin‐based malaria diagnostic test validated for vivax malaria diagnosis in Brazilian Amazon

Candidate subjects presenting for enrolment in the study

300

Total number of subjects enrolled and tested (full analysis population)

300

Subjects excluded from full analysis population

18

Reason: Data file not retrievable

1

Reason: Inconclusive Gazelle™ test result

17

Subject tested negative for malaria by other methods

12

Subject tested positive for P. vivax by other methods

3

Subject tested positive for P. falciparum by other methods

2

Number of subjects included in full data analysis (per protocol population)

282

Additional subjects excluded from the P. vivax data analysis subset

6

Reason: Subject tested positive for P. falciparuma

3

Reason: Subject tested positive for P. falciparum and P. vivax

3

Number of subjects included inP. vivaxdata analysis sub-set (P. vivaxpopulation)

276

  1. aThese 3 subjects infected with P. falciparum are in addition to the 2 subjects with P. falciparum excluded from the full analysis due to inconclusive Gazelle™ test results